Evaluation and Management of Chronic Insomnia in Adults

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 487

SUMMARY RECOMMENDATIONS

General:

Insomnia is an important public health problem that re-quires accurate diagnosis and effective treatment. (Stan-dard)

An insomnia diagnosis requires associated daytime dys-function in addition to appropriate insomnia symptomatol-ogy. (ICSD-2 definition)

Evaluation:

Insomnia is primarily diagnosed by clinical evaluation through a thorough sleep history and detailed medical, sub-stance, and psychiatric history. (Standard)• Thesleephistoryshouldcoverspecificinsomniacom-

plaints, pre-sleep conditions, sleep-wake patterns, oth-er sleep-related symptoms, and daytime consequences. (Consensus)

• Thehistoryhelpstoestablishthetypeandevolutionofinsomnia,perpetuatingfactors,andidentificationofcomorbid medical, substance, and/or psychiatric con-ditions. (Consensus)

Instruments which are helpful in the evaluation and dif-ferential diagnosis of insomnia include self-administered

questionnaires, at-home sleep logs, symptom checklists, psychological screening tests, and bed partner interviews. (Guideline)• Atminimum,thepatientshouldcomplete:(1)Agen-

eral medical/psychiatric questionnaire to identify co-morbiddisorders(2)TheEpworthSleepinessScaleorother sleepiness assessment to identify sleepy patients andcomorbiddisordersofsleepiness(3)Atwo-weeksleep log to identify general patterns of sleep-wake times and day-to-day variability. (Consensus)

• Sleepdiarydatashouldbecollectedpriortoanddur-ing the course of active treatment and in the case of relapse or reevaluation in the long-term. (Consensus)

• Additionalassessmentinstrumentsthatmayaidinthebaseline evaluation and outcomes follow-up of pa-tients with chronic insomnia include measures of sub-jective sleep quality, psychological assessment scales, daytime function, quality of life, and dysfunctional beliefs and attitudes. (Consensus)

Physical and mental status examination may provide im-portant information regarding comorbid conditions and differential diagnosis. (Standard)

Polysomnography and daytime multiple sleep latency test-ing(MSLT)arenotindicatedintheroutineevaluationofchronic insomnia, including insomnia due to psychiatric or neuropsychiatric disorders. (Standard)• Polysomnography is indicatedwhen there is reason-

able clinical suspicion of breathing (sleep apnea) ormovement disorders, when initial diagnosis is uncer-tain,treatmentfails(behavioralorpharmacologic),orprecipitous arousals occur with violent or injurious behavior. (Guideline)

Clinical Guideline for the Evaluation and Management of Chronic Insomnia in AdultsSharon Schutte-Rodin, M.D.1; Lauren Broch, Ph.D.2; Daniel Buysse, M.D.3; Cynthia Dorsey, Ph.D.4; Michael Sateia, M.D.5

1Penn Sleep Centers, Philadelphia, PA; 2Good Samaritan Hospital, Suffern, NY; 3UPMC Sleep Medicine Center, Pittsburgh, PA; 4SleepHealth Centers, Bedford, MA; 5Dartmouth-Hitchcock Medical Center, Lebanon, NH

Submitted for publication July, 2008Accepted for publication July, 2008Address correspondence to: Sharon L. Schutte-Rodin, M.D., Penn Sleep Centers, University of Pennsylvania Health System, 3624 Market St., 2nd Floor, Philadelphia, PA 19104; Tel: (215) 615-3669; Fax: (215) 615-4835; E-mail: [email protected]

SpECIAl ARTIClE

Insomnia is the most prevalent sleep disorder in the general popula-tion, and is commonly encountered in medical practices. Insomnia is defined as the subjective perception of difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate oppor-tunity for sleep, and that results in some form of daytime impairment.1 Insomnia may present with a variety of specific complaints and eti-ologies, making the evaluation and management of chronic insomnia demanding on a clinician’s time. The purpose of this clinical guideline is to provide clinicians with a practical framework for the assessment

and disease management of chronic adult insomnia, using existing evidence-based insomnia practice parameters where available, and consensus-based recommendations to bridge areas where such pa-rameters do not exist. Unless otherwise stated, “insomnia” refers to chronic insomnia, which is present for at least a month, as opposed to acute or transient insomnia, which may last days to weeks.Citation: Schutte-Rodin S; Broch L; Buysse D; Dorsey C; Sateia M. Clinical guideline for the evaluation and management of chronic in-somnia in adults. J Clin Sleep Med 2008;4(5):487-504.


S Schutte-Rodin, L Broch, D Buysse et al

Actigraphy is indicated as a method to characterize circa-dian rhythm patterns or sleep disturbances in individuals with insomnia, including insomnia associated with depres-sion. (Option)

Otherlaboratorytesting(e.g.,blood,radiographic)isnotin-dicated for the routine evaluation of chronic insomnia unless there is suspicion for comorbid disorders. (Consensus)

Differential Diagnosis:

Thepresenceofone insomniadisorderdoesnot excludeother disorders, as multiple primary and comorbid insom-nia disorders may coexist. (Consensus)

Treatment Goals/Treatment Outcomes:

Regardlessofthetherapytype,primarytreatmentgoalsare:(1)toimprovesleepqualityandquantityand(2)toimproveinsomnia related daytime impairments. (Consensus)

Other specificoutcome indicators for sleepgenerally in-cludemeasures ofwake time after sleep onset (WASO),sleeponset latency (SOL), numberof awakenings, sleeptimeorsleepefficiency,formationofapositiveandclearassociation between the bed and sleeping, and improve-ment of sleep related psychological distress. (Consensus)

Sleep diary data should be collected prior to and duringthe course of active treatment and in the case of relapse or reevaluationinthelongterm(every6months).(Consen-sus)

In addition to clinical reassessment, repeated administra-tion of questionnaires and survey instruments may be use-ful in assessing outcome and guiding further treatment ef-forts. (Consensus)

Ideally, regardless of the therapy type, clinical reassess-ment should occur every few weeks and/or monthly until theinsomniaappearsstableorresolved,andthenevery6months, as the relapse rate for insomnia is high. (Consen-sus)

Whenasingletreatmentorcombinationoftreatmentshasbeen ineffective, other behavioral therapies, pharmacologi-cal therapies, combined therapies, or reevaluation for oc-cult comorbid disorders should be considered. (Consen-sus)

psychological and Behavioral Therapies:

Psychological and behavioral interventions are effective and recommended in the treatment of chronic primary and comorbid(secondary)insomnia.(Standard)• These treatments are effective for adultsof all ages,

including older adults, and chronic hypnotic users. (Standard)

• Thesetreatmentsshouldbeutilizedasaninitialinter-vention when appropriate and when conditions permit. (Consensus)

Initial approaches to treatment should include at least one behavioral intervention such as stimulus control therapy or relaxation therapy, or the combination of cognitive thera-py, stimulus control therapy, sleep restriction therapy with

or without relaxation therapy—otherwise known as cogni-tivebehavioraltherapyforinsomnia(CBT-I).(Standard)

Multicomponent therapy (without cognitive therapy) iseffective and recommended therapy in the treatment of chronic insomnia. (Guideline)

Other common therapies include sleep restriction, para-doxical intention, and biofeedback therapy. (Guideline)

Although all patients with chronic insomnia should adhere to rules of good sleep hygiene,thereisinsufficientevidenceto indicate that sleep hygiene alone is effective in the treat-ment of chronic insomnia. It should be used in combination with other therapies. (Consensus)

When an initial psychological/ behavioral treatment hasbeen ineffective, other psychological/ behavioral therapies, combination CBT-I therapies, combined treatments (seebelow),oroccultcomorbiddisordersmaynextbeconsid-ered. (Consensus)

pharmacological Treatment:

Short-term hypnotic treatment should be supplementedwith behavioral and cognitive therapies when possible. (Consensus)

Whenpharmacotherapyisutilized,thechoiceofaspecificpharmacological agent within a class, should be directed by:(1)symptompattern;(2)treatmentgoals;(3)pasttreat-mentresponses;(4)patientpreference;(5)cost;(6)avail-ability of other treatments; (7) comorbid conditions; (8)contraindications; (9)concurrentmedication interactions;and(10)sideeffects.(Consensus)

For patients with primary insomnia (psychophysiologic,idiopathic or paradoxical ICSD-2 subtypes), when phar-macologic treatment is utilized alone or in combination therapy, the recommended general sequence of medication trialsis: (Consensus)• Short-intermediateactingbenzodiazepinereceptorago-

nists(BZDornewerBzRAs)orramelteon:examplesofthese medications include zolpidem, eszopiclone, zale-plon, and temazepam

• Alternateshort-intermediateactingBzRAsorramelt-eon if the initial agent has been unsuccessful

• Sedatingantidepressants,especiallywhenusedincon-junction with treating comorbid depression/anxiety:examples of these include trazodone, amitriptyline, doxepin, and mirtazapine

• Combined BzRA or ramelteon and sedating antide-pressant

• Othersedatingagents:examplesincludeanti-epilepsymedications (gabapentin, tiagabine) and atypical an-tipsychotics(quetiapineandolanzapine) Thesemedicationsmayonlybe suitable forpa-

tientswithcomorbid insomniawhomaybenefitfrom the primary action of these drugs as well as from the sedating effect.

Over-the-counter antihistamine or antihistamine/analgesic typedrugs (OTC“sleepaids”)aswellasherbalandnu-tritionalsubstances(e.g.,valerianandmelatonin)arenotrecommended in the treatment of chronic insomnia due to therelativelackofefficacyandsafetydata.(Consensus)


Evaluation and Management of Chronic Insomnia in Adults

Older approved drugs for insomnia including barbiturates, barbiturate-type drugs and chloral hydrate are not recom-mended for the treatment of insomnia. (Consensus)

Thefollowingguidelinesapplytoprescriptionofallmedi-cations for management of chronic insomnia: (Consen-sus)• Pharmacologicaltreatmentshouldbeaccompaniedby

patient education regarding: (1) treatment goals andexpectations; (2) safety concerns; (3) potential sideeffectsanddruginteractions;(4)othertreatmentmo-dalities(cognitiveandbehavioraltreatments);(5)po-tentialfordosageescalation;(6)reboundinsomnia.

• Patientsshouldbefollowedonaregularbasis,everyfew weeks in the initial period of treatment when pos-sible, to assess for effectiveness, possible side effects, and the need for ongoing medication.

• Effortsshouldbemadetoemploythelowesteffectivemaintenance dosage of medication and to taper medi-cation when conditions allow. Medication tapering and discontinuation are fa-

cilitatedbyCBT-I.• Chronichypnoticmedicationmaybeindicatedforlong-

term use in those with severe or refractory insomnia or chroniccomorbidillness.Wheneverpossible,patientsshould receive an adequate trial of cognitive behavioral treatment during long-term pharmacotherapy. Long-termprescribingshouldbeaccompaniedby

consistent follow-up, ongoing assessment of ef-fectiveness, monitoring for adverse effects, and evaluation for new onset or exacerbation of exist-ing comorbid disorders

Long-termadministrationmaybenightly,intermit-tent(e.g.,threenightsperweek),orasneeded.

Combined Treatments:

The use of combined therapy (CBT-I plus medication)shouldbedirectedby(1)symptompattern;(2)treatmentgoals;(3)pasttreatmentresponses;(4)patientpreference;(5)cost;(6)availabilityofothertreatments;(7)comorbidconditions; (8) contraindications; (9) concurrentmedica-tioninteractions;and(10)sideeffects.(Consensus)

Combinedtherapyshowsnoconsistentadvantageordis-advantage over CBT-I alone. Comparisons to long-termpharmacotherapy alone are not available. (Consensus)

INTRODUCTION

Insomnia symptomsoccur in approximately33% to50%oftheadultpopulation;insomniasymptomswithdistressorim-

pairment(generalinsomniadisorder)in10%to15%.Consistentrisk factors for insomnia include increasing age, female sex, co-morbid (medical, psychiatric, sleep, and substanceuse)disor-ders, shift work, and possibly unemployment and lower socio-economicstatus.“Insomnia”hasbeenusedindifferentcontextstorefertoeitherasymptomoraspecificdisorder.Inthisguide-line, an insomniadisorder isdefinedas a subjective reportofdifficultywithsleepinitiation,duration,consolidation,orqual-ity that occurs despite adequate opportunity for sleep, and that

resultsinsomeformofdaytimeimpairment.Becauseinsomniamaypresentwithavarietyofspecificcomplaintsandcontribut-ing factors, the time required for evaluation and management of chronicinsomniacanbedemandingforclinicians.Thepurposeof this clinical guideline is to provide clinicians with a frame-work for the assessment and management of chronic adult in-somnia, using existing evidence-based insomnia practice param-eters where available, and consensus-based recommendations to bridge areas where such parameters do not exist.

METHODS

Thisclinicalguidelineincludesbothevidence-basedandcon-sensus-based recommendations. In the guideline summary rec-ommendation section, each recommendation is accompanied by itslevelofevidence:standard,guideline,option,orconsensusbased.“Standard,”“guideline,”and“option”recommendationswere incorporated from evidence-based American Academy of SleepMedicine(AASM)practiceparameterpapers.“Consen-sus”recommendationsweredevelopedusingamodifiednomi-nal group technique.The development of these recommenda-tions and their appropriate use are described below.

Evidence-Based practice parameters

Inthedevelopmentofthisguideline,existingAASMprac-tice parameter papers relevant to the evaluation and manage-ment of chronic insomnia in adults were incorporated.2-6Thesepractice parameter papers,many ofwhich addressed specificinsomnia-related topics rather than providing a comprehensive clinical chronic insomnia practice guideline for clinicians, were previously developed via a computerized, systematic search of thescientificliterature(forspecificsearchtermsandfurtherde-tails,seereferencedpracticeparameter)andsubsequentcriticalreview, evaluation, and evidence-grading of all pertinent stud-ies.7OnthebasisofthisreviewtheAASMStandardsofPractice

Committeedevelopedpracticeparameters.Practiceparametersweredesignatedas“Standard,”“Guideline,”or“Option”basedonthequalityandamountofscientificevidenceavailable(Ta-ble1).

Consensus-Based Recommendations

Consensus-basedrecommendationsweredevelopedforthisclinical guideline to address important areas of clinical practice thathadnotbeenthesubjectofapreviousAASMpracticeparam-eter, or where the available empirical data was limited or incon-clusive.Consensus-based recommendations reflect thesharedjudgment of the committee members and reviewers, based on the literature and common clinical practice of topic experts, and weredevelopedusingamodifiednominalgrouptechnique.AnexpertinsomniapanelwasassembledbytheAASMtoauthorthisclinicalguideline.InadditiontousingallAASMpracticeparametersandAASMSleeppublicationsthroughJuly2007,the expert panel reviewed other relevant source articles from a Medlinesearch(1999toOctober2006;alladultagesincludingseniors;“insomniaand”keywordsrelatingtoevaluation,test-ing, and treatments. Using a face-to-face meeting, voting sur-


Table 2—DiagnosticCriteriaforInsomnia(ICSD-2)

A.Acomplaintofdifficulty initiatingsleep,difficultymaintain-Acomplaintofdifficulty initiatingsleep,difficultymaintain-ing sleep, or waking up too early, or sleep that is chronically nonrestorative or poor in quality.

B.Theabovesleepdifficultyoccursdespiteadequateopportunityand circumstances for sleep.

C.Atleastoneofthefollowingformsofdaytimeimpairmentre-latedtothenighttimesleepdifficultyisreportedbythepatient:1. Fatigueormalaise;2. Attention,concentration,ormemoryimpairment;3. Socialorvocationaldysfunctionorpoorschoolperformance;4. Mooddisturbanceorirritability;5. Daytimesleepiness;6. Motivation,energy,orinitiativereduction;7. Pronenessforerrors/accidentsatworkorwhiledriving;8. Tension, headaches, or gastrointestinal symptoms in re-

sponsetosleeploss;and9. Concernsorworriesaboutsleep.

treatment options, resources available, and other relevant fac-tors.TheAASMexpectsthisclinicalguidelinetohaveanim-pactonprofessionalbehaviorandpatientoutcomes.Itreflectsthe state of knowledge at the time of publication and will be reviewed, updated, and revised as new information becomes available.

INSOMNIA DEFINITIONS AND EpIDEMIOlOGY

Insomnia Definitions

“Insomnia” has been used in different contexts to refer toeither a symptomor a specificdisorder. In this guideline, aninsomniadisorderisdefinedasasubjectivereportofdifficultywith sleep initiation, duration, consolidation, or quality that oc-curs despite adequate opportunity for sleep, and that result in someformofdaytimeimpairment(Table2).Exceptwhereotherwisenoted,theword“insomnia”refersto

an insomnia disorder in this guideline.Insomnia disorders have been categorized in various ways in

differentsleepdisorderclassificationsystems.TheInternationalClassificationofSleepDisorders,2ndEdition(ICSD-2)isusedas thebasis for insomnia classification in this guideline.TheICSD-2identifiesinsomniaasoneofeightmajorcategoriesofsleepdisordersand,withinthisgroup,liststwelvespecificin-somniadisorders(Table3).ICSD-2delineatesbothgeneraldiagnosticcriteriathatapply

toall insomniadisorders,aswellasmorespecificcriteriaforeach diagnosis. Insomnia complaints may also occur in asso-ciation with comorbid disorders or other sleep disorder catego-ries, such as sleep related breathing disorders, circadian rhythm sleep disorders, and sleep related movement disorders.

Epidemiology

Insomnia occurs in individuals of all ages and races, and has been observed across all cultures and countries.8,9 The actualprevalence of insomnia varies according to the stringency of the definitionused.Insomniasymptomsoccurinapproximately33%to 50%of the adult population; insomnia symptomswith dis-tressorimpairment(i.e.,general insomniadisorder) in10%to15%;andspecific insomniadisorders in5%to10%.10Consis-tent risk factors for insomnia include increasing age, female sex, comorbid(medical,psychiatric,sleep,andsubstanceuse)disor-ders, shift work, and possibly unemployment and lower socio-economic status. Patients with comorbid medical and psychiatric conditions are at particularly increased risk, with psychiatric and chronicpaindisordershavinginsomniaratesashighas50%to75%.11-13Theriskrelationshipbetweeninsomniaandpsychiatricdisordersappears tobebidirectional; several studieshavealso

veys, and frequent teleconference discussions, the expert panel identifiedconsensusareasandrecommendationsforthoseareasnotcoveredbyAASMpracticeparameters.Recommendationsweregeneratedbypanelmembersanddiscussedbyall.Tomin-imize individual expert bias, the group anonymously voted and ratedconsensusrecommendationsfrom1:stronglydisagreeto9:stronglyagree.Consensuswasdefinedwhenallexpertsrateda recommendation8or9. If consensuswasnotevidentafterthefirstvote,theconsensusrecommendationswerediscussedagain, amended as appropriate, and a second anonymous vote was conducted. If consensus was not evident after the second vote, the process was repeated until consensus was attained to include or exclude a recommendation.

Use of practice parameters and Clinical Guidelines

AASM practice parameter papers are based on evidence-based review and grading of literature, often addressing a spe-cificissueortopic.Clinicalguidelinesprovideclinicianswithaworking overview for disease or disorder evaluation and man-agement.These guidelines include practice parameter papersand also include areas with limited evidence in order to provide acomprehensivepracticeguideline.Bothpracticeparametersandclinicalguidelinesdefineprinciplesofpracticethatshouldmeettheneedsofmostpatients.Theyshouldnot,however,beconsidered exhaustive, inclusive of all available methods of care, or exclusive of other methods of care reasonably expected to obtain the same results. The ultimate judgment regardingappropriatenessof any specific therapymustbemadeby theclinician and patient in light of the individual circumstances presented by the patient, available diagnostic tools, accessible

Table 1—AASMLevelsofRecommendations

Term DefinitionStandard Thisisagenerallyacceptedpatient-carestrategythatreflectsahighdegreeofclinicalcertainty.Thetermstandardgenerally

impliestheuseofLevel1Evidence,whichdirectlyaddressestheclinicalissue,oroverwhelmingLevel2Evidence.Guideline Thisisapatient-carestrategythatreflectsamoderatedegreeofclinicalcertainty.Thetermguidelineimpliestheuseof

Level2EvidenceoraconsensusofLevel3Evidence.Option Thisisapatient-carestrategythatreflectsuncertainclinicaluse.Thetermoptionimpliesinsufficient,inconclusive,orcon-

flictingevidenceorconflictingexpertopinion.



demonstrated an increased risk of psychiatric disorders among individuals with prior insomnia.13Thecourseofinsomniaisof-tenchronic,withstudiesshowingpersistencein50%to85%ofindividuals over follow-up intervals of one to several years.14

DIAGNOSIS OF CHRONIC INSOMNIA

Evaluation

Theevaluationofchronic insomnia isenhancedbyunder-standing models for the evolution of chronic insomnia.15-18 Numerous models may be reasonable from neurobiological, neurophysiological,cognitive,behavioral(andother)perspec-tives. Although details of current models are beyond the scope of this practice guideline, general model concepts are critical for identifying biopsychosocial predisposing factors (such ashyperarousal, increased sleep-reactivity, or increased stress response),precipitatingfactors,andperpetuatingfactorssuchas(1)conditionedphysicalandmentalarousaland(2)learnednegative sleep behaviors and cognitive distortions. In particu-lar, identificationofperpetuatingnegativebehaviorsandcog-nitive processes often provides the clinician with invaluable information for diagnosis as well as for treatment strategies. In contrast to evolvingmodels and diagnostic classificationsfor insomnia, procedures for clinical evaluation have remained relatively stable over time.Evaluation continues to rest on acareful patient history and examination that addresses sleep and wakingfunction(Table4),aswellascommonmedical,psychi-atric, andmedication/substance-related comorbidities (Tables5,6,and7).Theinsomniahistoryincludesevaluationof:

I. The Primary Complaint: Patients with insomnia may complainofdifficultyfallingasleep,frequentawakenings,dif-ficultyreturningtosleep,awakeningtooearlyinthemorning,or sleep that does not feel restful, refreshing, or restorative. Al-though patients may complain of only one type of symptom, it is common for multiple types of symptoms to co-occur, and for thespecificpresentationtovaryovertime.Keycomponentsin-cludecharacterizationofthecomplainttype,duration(months,years,lifetime),frequency(nightsperweekornumberoftimespernight),severityofnighttimedistressandassociateddaytimesymptomatology,course(progressive,intermittent,relentless),factorswhich increaseor decrease symptoms, and identifica-tion of past and current precipitants, perpetuating factors, treat-ments, and responses.


ICSD-2 Sleep Disorder Categories: Insomnias Sleep Related Breathing Disorders Hypersomnias of Central Origin Circadian Rhythm Disorders Parasomnias Sleep Related Movement Disorders Isolated Symptoms Other Sleep Disorders

Insomnias (specific disorders) Adjustment (Acute) Insomnia Behavioral Insomnia of Childhood Psychophysiological Insomnia Paradoxical Insomnia Idiopathic Insomnia Inadequate Sleep Hygiene Insomnia Due to Mental Disorder Insomnia Due to Medical Condition Insomnia Due to Drug or Substance Insomnia Not Due to Substance or Known Physiological Condition, Unspecified Physiological (Organic) Insomnia, Unspecified

Table 3—ICSD-2InsomniaDiagnoses

Table 4—SleepHistory

Primary insomnia complaint: CharacterizationofComplaint(s): • Difficultyfallingasleep • Awakenings • Poororunrefreshingsleep Onset Duration Frequency Severity Course Perpetuating factors Past and current treatments and responses Pre-Sleep Conditions: Pre-bedtime activities Bedroomenvironment EveningphysicalandmentalstatusSleep-Wake Schedule (average, variability): Bedtime: Timetofallasleep • Factorsprolongingsleeponset • Factorsshorteningsleep Awakenings • number,characterization,duration; • associatedsymptoms • associatedbehaviors FinalawakeningversusTimeoutofbed Amount of sleep obtained Nocturnal Symptoms: Respiratory Motor Other medical BehavioralandpsychologicalDaytime Activities and Function: Identify sleepiness versus fatigue Napping Work Lifestyle Travel Daytimeconsequences(seeICSD-2Criteria-Table2) • QualityofLife • Mooddisturbance • Cognitivedysfunction • Exacerbationofcomorbidconditions


Table 5—Common Comorbid Medical Disorders, Conditions,andSymptoms

System Examples of disorders, conditions, and symptoms

Neurological Stroke,dementia,Parkinsondisease,seizuredisorders, headache disorders, traumatic brain injury, peripheral neuropathy, chronic pain disorders, neuromuscular disorders

Cardiovascular Angina,congestiveheartfailure,dyspnea,dysrhythmias

Pulmonary COPD,emphysema,asthma,laryngospasmDigestive Reflux,pepticulcerdisease,cholelithiasis,

colitis, irritable bowel syndrome Genitourinary Incontinence,benignprostatichypertrophy,

nocturia, enuresis, interstitial cystitis Endocrine Hypothyroidism,hyperthyroidism,diabetes

mellitusMusculoskeletal Rheumatoidarthritis,osteoarthritis,

fibromyalgia,Sjögrensyndrome,kyphosisReproductive Pregnancy, menopause, menstrual cycle

variationsSleepdisorders Obstructivesleepapnea,centralsleep

apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorders, parasomnias

Other Allergies, rhinitis, sinusitis, bruxism, alcohol and other substance use/dependence/withdrawal

Table 6—CommonComorbidPsychiatricDisordersandSymptoms

Category ExamplesMooddisorders Majordepressivedisorder,bipolarmooddisorder,dysthymiaAnxietydisorders Generalizedanxietydisorder,panicdisorder,posttraumaticstressdisorder,

obsessive compulsive disorderPsychoticdisorders Schizophrenia,schizoaffectivedisorderAmnestic disorders Alzheimer disease, other dementiasDisordersusuallyseeninchildhoodandadolescence AttentiondeficitdisorderOther disorders and symptoms Adjustment disorders, personality disorders, bereavement, stress

timetofallasleep(sleeplatency),numberofawakenings,waketimeaftersleeponset(WASO),sleepduration,andnappingcanbequantifiedretrospectivelyduringtheclinicalassessmentandprospectivelywithsleep-wakelogs.Althoughnospecificquan-titative sleep parameters define insomnia disorder, commoncomplaints for insomnia patients are an average sleep latency >30minutes,wake after sleep onset>30minutes, sleep effi-ciency<85%,and/ortotalsleeptime<6.5hours.19,20Day-to-dayvariability should be considered, as well as variability during longer periodicities such as those that may occur with the men-strual cycle or seasons. Patterns of sleep at unusual times may assist inidentifyingCircadianRhythmDisorderssuchasAd-vancedSleepPhaseTypeorDelayedSleepPhaseType.Assess-ingwhetherthefinalawakeningoccursspontaneouslyorwithan alarm adds insight into the patient’s sleep needs and natural sleep and wake rhythm. Finally, the clinician must ascertain whether the individual’s sleep and daytime complaints occur despite adequate time available for sleep, in order to distinguish insomniafrombehaviorallyinducedinsufficientsleep.

IV. Nocturnal Symptoms: Patient and bed partner reports may also help to identify nocturnal signs, symptoms and behav-iorsassociatedwithbreathing-relatedsleepdisorders(snoring,gasping, coughing), sleep relatedmovement disorders (kick-ing,restlessness),parasomnias(behaviorsorvocalization),andcomorbidmedical/neurologicaldisorders (reflux,palpitations,seizures,headaches).Otherphysical sensations andemotionsassociatedwithwakefulness(suchaspain, restlessness,anxi-ety,frustration,sadness)maycontributetoinsomniaandshouldalso be evaluated.

V. Daytime Activities and Daytime Function: Daytimeactivities and behaviors may provide clues to potential causes and consequences of insomnia. Napping (frequency/day,times, voluntary/involuntary),work (work times,work typesuch as driving or with dangerous consequences, disabled, caretaker responsibilities), lifestyle (sedentary/active,home-bound, light exposure, exercise), travel (especially acrosstimezones),daytimedysfunction(qualityoflife,mood,cog-nitivedysfunction), andexacerbationof comorbiddisordersshouldbeevaluatedindepth.Commondaytimeconsequencesinclude:• Fatigue and sleepiness. Feelings of fatigue (low energy,

physical tiredness, weariness) are more common thansymptomsofsleepiness(actualtendencytofallasleep)inpatientswithchronicinsomnia.Thepresenceofsignificantsleepiness should prompt a search for other potential sleep disorders.Thenumber,duration,andtimingofnapsshouldbe thoroughly investigated, as both a consequence of in-somnia and a potential contributing factor.

II. Pre-Sleep Conditions: Patients with insomnia may de-velop behaviors that have the unintended consequence of per-petuating their sleepproblem.Thesebehaviorsmaybegin asstrategies to combat the sleep problem, such as spending more timeinbedinaneffortto“catchup”onsleep.Otherbehaviorsin bed or in the bedroom that are incompatible with sleep may include talking on the telephone, watching television, computer use,exercising,eating,smoking,or“clockwatching.”Insom-nia patients may report sensations of being more aware of the environment than are other individuals and may report antici-pating a poor sleep hours before bedtime, and become more alert and anxious as bedtime approaches.Characterizationofthe sleeping environment (couch/bed, light/dark, quiet/noisy,roomtemperature,alone/bedpartner,TVon/off)aswellasthepatient’sstateofmind(sleepyvs.wideawake,relaxedvs.anx-ious)ishelpfulinunderstandingwhichfactorsmightfacilitateor prolong sleep onset or awakenings after sleep.

III. Sleep-Wake Schedule: In evaluating sleep-related symptoms, the clinician must consider not only the patient’s “usual”symptoms,butalsotheirrange,day-to-dayvariability,andevolutionovertime.Specificsleep-wakevariablessuchas



insomnia.Likewise,thedirecteffectsofover-the-counterandprescription medications and substances (Table 7), and theireffects upon withdrawal, may impact both sleep and daytime symptoms.Conditionsoftencomorbidwithinsomnia,suchasmood and anxiety disorders, may also have familial or genetic components.Socialandoccupationalhistoriesmayindicatenotonly the effects of insomnia on the individual, but also possible contributing factors.Occupational assessment should specifi-cally include work around dangerous machinery, driving duties, regular or irregular shift-work and transmeridian travel.

Physical and Mental Status Examination: Chronic in-somnia isnot associatedwith any specific featuresonphysi-calormentalstatusexamination.However, theseexamsmayprovide important information regarding comorbid conditions anddifferentialdiagnosis.Aphysicalexamshouldspecificallyevaluate risk factors for sleep apnea (obesity, increasedneckcircumference,upperairwayrestrictions)andcomorbidmedi-cal conditions that include but are not limited to disorders of pulmonary, cardiac, rheumatologic, neurological, endocrine (suchasthyroid),andgastrointestinalsystems.Thementalsta-tus exam should focus on mood, anxiety, memory, concentra-tion, and degree of alertness or sleepiness.

Supporting Information: Whileathoroughclinicalhistoryand exam form the core of the evaluation, differential diagno-sis is further aided by the use of sleep logs, questionnaires for sleep quality, sleepiness, psychological assessment and quality oflife(Table8),andinsomecases,actigraphy.21-23Forspecificinsomnias, psychological testing, quality of life questionnaires, andothercomorbidquestionnairesandtestingareuseful.Thechoice of assessment tools should be based on the patient’s pre-sentation and the clinician’s expertise. At minimum, the patient shouldcomplete:(1)Ageneralmedical/psychiatric/medicationquestionnaire

(toidentifycomorbiddisordersandmedicationuse)(2)TheEpworthSleepinessScaleorothersleepinessassess-

ment(toidentifysleepypatients)24(3)Atwo-weeksleeplogtoidentifysleep-waketimes,gen-

eral patterns, and day-to-day variability.When possible, questionnaires and a two-week sleep log

shouldbecompletedpriortothefirstvisittobegintheprocess

• Mood disturbances and cognitive difficulties.Complaintsof irritability, loss of interest, mild depression and anxi-ety are common among insomnia patients. Patients with chronic insomnia often complain of mental inefficiency,difficulty remembering,difficulty focusingattention, anddifficultywithcomplexmentaltasks.

• Quality of life:Theirritabilityandfatigueassociatedwithinsomniamaycauseinterpersonaldifficultiesforinsomniapatients, or avoidance of such activities. Conversely, in-terpersonaldifficultiesmaybeanimportantcontributortoinsomniaproblemsforsomeindividuals.Sleepandwak-ing problems may lead to restriction of daytime activities, includingsocialevents,exercise,orwork.Lackofregulardaytime activities and exercise may in turn contribute to insomnia.

• Exacerbation of comorbid conditions. Comorbid condi-tionsmay cause or increase sleep difficulties. Likewise,poor sleep may exacerbate symptomatology of comorbid conditions.Sleepcomplaintsmayheraldtheonsetofmooddisorders or exacerbation of comorbid conditions.

VI. Other History: A complete insomnia history also in-cludes medical, psychiatric, medication/substance, and family/social/occupationalhistories.Awide rangeofmedical (Table5)andpsychiatric(Table6)conditionscanbecomorbidwith

Evaluation and Management of Chronic Insomnia in AdultsTable 7—CommonContributingMedicationsandSubstances

Category Examples Antidepressants SSRIs (fluoxetine, paroxetine, sertraline,

citalopram, escitalopram, fluvoxamine),venlafaxine, duloxetine, monoamine oxi-dase inhibitors

Stimulants Caffeine, methylphenidate, amphetaminederivatives, ephedrine and derivatives, co-caine

Decongestants Pseudoephedrine, phenylephrine, phenyl-propanolamine

Narcotic analgesics Oxycodone, codeine, propoxypheneCardiovascular β-Blockers, α-receptor agonists and an-

tagonists, diuretics, lipid-lowering agentsPulmonary Theophylline,albuterolAlcohol

Table 8—ExamplesofInsomniaQuestionnairesUsedinBaselineandTreatmentOutcomeAssessment

Questionnaire DescriptionEpworthSleepinessScale ESSisan8-itemselfreportquestionnaireusedtoassesssubjectivesleepiness(scorerange:

0-24;normal<10).

InsomniaSeverityIndex ISIisa7-itemratingusedtoassessthepatient’sperceptionofinsomnia.

PittsburghSleepQualityIndex PSQIisa24-itemselfreportmeasureofsleepquality(poorsleep:globalscore>5).

BeckDepressionInventory BDI(orBDI-II)isa21-itemselfreportinventoryusedtomeasuredepression(minimalornodepression:BDI<10;moderatetosevere:BDI>18).

State-TraitAnxietyInventory- STAIisa20-itemselfreportinventoryusedtomeasureanxiety(scorerange:20-80;FormYTraitScale minimumanxiety:T-score<50;significantanxiety:Tscore>70).

FatigueSeverityScale FSSisa9-itempatientratingofdaytimefatigue.

ShortFormHealthSurvey(SF-36) SF-36isa36-itemselfreportinventorythatgenericallymeasuresqualityoflifeforanydis-order(rangefrom0(poorest)to100(well-being).

DysfunctionalBeliefsandAttitudes DBASisaself-ratingof28statementsthatisusedtoassessnegativecognitionsaboutsleep.aboutSleepQuestionnaire


patients with chronic insomnia have daytime impairment of cognition, mood, or performance that impacts on the patient and potentially on family, friends, coworkers and caretakers. Chronicinsomniapatientsaremorelikelytousehealthcareresources, visit physicians, be absent or late for work, make errors or have accidents at work, and have more serious road accidents.25,26 Increased risk for suicide, substance use relapse, and possible immune dysfunction have been reported.27Co-morbid conditions, particularly depression, anxiety, and sub-stance use, are common. There is a bidirectional increasedrisk between insomnia and depression. Other medical condi-tions, unhealthy lifestyles, smoking, alcoholism, and caffeine dependencearealsorisksforinsomnia.Selfmedicationwithalcohol, over-the-counter medications, prescription medica-tions, and melatonin account for millions of dollars annual-ly.28Cliniciansshouldbealerttothesepossibleindividualandsocietal risks during the evaluation.

Genetics: With the exceptionof fatal familial insomnia, araredisorder,nospecificgeneticassociationshavebeenidenti-fied for insomnia.A familial tendency for insomniahasbeenobserved, but the relative contributions of genetic trait vulner-ability and learned maladaptive behaviors are unknown.

General Considerations and Treatment Goals

It is essential to recognize and treat comorbid conditions (e.g., major depression or medical disorder such as chronicpain)thatcommonlyoccurwithinsomnia.29Likewise,identifi-cationandmodificationofinappropriatecaffeine,alcohol,andself-medicationarenecessary.Timingoradjustmentsofcurrentmedications require consideration and may provide symptom relief. For example, changing to a less stimulating antidepres-sant or changing the timing of a medication may improve sleep or daytime symptoms.Goalsofinsomniatreatment(Table10)includereductionof

sleep and waking symptoms, improvement of daytime function, andreductionofdistress.Treatmentoutcomecanbemonitoredlongitudinally with clinical evaluation, questionnaires, and sleep logs.Before consideration of treatment choices, the patient and

physician should discuss primary and secondary treatment goals based on the primary complaint and baseline measures such as sleep latency, number of awakenings,WASO, frequency andseverityofthecomplaint(s),nighttimedistress,andrelatedday-timesymptoms(Table10).Afterdiscussingtreatmentoptionstailoredtoaddresstheprimarycomplaint,aspecificfollow-upplan and time frame should be outlined with the patient, regard-less of the treatment choice.Quantifying sleep quality, daytime function, and improve-

ment in comorbid conditions requires more involved assess-ment,oftenusingspecificquestionnairesforspecificinsomniaproblems(Table8).Iftheclinicianisunfamiliarwiththesetests,administration and monitoring of these measures may require referral to a behavioral sleep medicine specialist, psychologist, or other testing professional, as clinically appropriate.

Psychological and behavioral interventions and benzodiaz-epinereceptoragonists(BzRAs)havedemonstratedshort-termefficacy for the treatmentofchronic insomnia.Psychologicalandbehavioralinterventionsshowshortandlongtermefficacy

of the patient viewing global sleep patterns, in contrast with one specificnight,andtoenlistthepatientintakinganactiverolein treatment. Primary baseline measures obtained from a sleep loginclude:• Bedtime• Sleeplatency(SL:timetofallasleepfollowingbedtime)• Numberofawakeningsanddurationofeachawakening• Wake after sleep onset (WASO: the sum of wake times

fromsleeponsettothefinalawakening)• Timeinbed(TIB:timefrombedtimetogettingoutofbed)• Total sleep time (TST: time inbedminusSLandminus

WASO)• Sleepefficiencypercent (SEequalsTSTdividedbyTIB

times100)• Naptimes(frequency,times,durations)Sleeplogsmayalsoincludereportsofsleepquality,daytime

impairment, medications, caffeine, and alcohol consumption foreach24-hourperiod.

Objective Assessment Tools: Laboratorytesting,polysom-nography and actigraphy are not routinely indicated in the eval-uation of insomnia, but may be appropriate in individuals who presentwithspecificsymptomsorsignsofcomorbidmedicalor sleep disorders.

Differential Diagnosis

Theinsomniaandinsomnia-relateddisorderslistedinICSD-2canbeconsideredconceptuallyinthreemajorgroupings: Insomnia associated with other sleep disorders most com-

monlyincludessleeprelatedbreathingdisorders(e.g.,ob-structivesleepapnea),movementdisorders (e.g., restlesslegsorperiodiclimbmovementsduringsleep)orcircadianrhythmsleepdisorders;

Insomnia due to medical or psychiatric disorders or to drug/substance(comorbidinsomnia);and

Primary insomnias including psychophysiological, idio-pathic, and paradoxical insomnias.

Table9describesthekeyfeaturesofICSD-2insomniadis-orders.Figure1presentsadiagnosticalgorithmforchronicin-somniabasedonthefeaturesdescribedinTable9.Itshouldbenoted that comorbid insomnias and multiple insomnia diagno-sesmay coexist and require separate identification and treat-ment.

TREATMENT OF CHRONIC INSOMNIA

Indications for Treatment

Treatmentisrecommendedwhenthechronicinsomniahasa significant negative impact on the patient’s sleep quality,health, comorbid conditions, or daytime function. It is essential to recognize and treat comorbid conditions that commonly oc-cur with insomnia, and to identify and modify behaviors and medications or substances that impair sleep.

Risk Counseling

Public Health Burden and Public Safety: Insomnia causes both individual and societal burdens. By definition,



develop and become key perpetuating factors that can be targeted withpsychologicalandbehavioraltherapies.Treatmentswhichaddress these core components play an important role in the man-agement of both primary and comorbid insomnias.29Thesetreat-ments are effective for adults of all ages, including older adults. Whilemostefficacystudieshavefocusedonprimaryinsomniapatients, more recent data demonstrate comparable outcomes in patients with comorbid psychiatric or medical insomnia.The etiology of insomnia is typicallymultifactorial. In co-

morbid insomnias, treatment begins by addressing the comorbid condition.Thismayincludetreatmentofmajordepressivedis-order, optimal management of pain or other medical conditions, elimination of activating medications or dopaminergic therapy for movement disorder. In the past, it was widely assumed that treatment of these comorbid disorders would eliminate the in-somnia.However,ithasbecomeincreasinglyapparentthatoverthe course of these disorders, numerous psychological and be-havioral factors develop which perpetuate the insomnia problem. These perpetuating factors commonly includeworry about in-

and can be used for treatment of both primary and comorbid in-somnias. Psychological and behavioral interventions and phar-macological interventions may be used alone or in combination (Figure2).Regardlessof treatmentchoice, frequentoutcomeassessment and patient feedback is an important component of treatment. In addition, periodic clinical reassessment following completion of treatment is recommended as the relapse rate for chronic insomnia is high.

psychological and Behavioral Therapies

Currentmodelssuggestthatphysiologicalandcognitivehy-perarousal contribute to the evolution and chronicity of insom-nia. In addition, patients typically develop problematic behaviors such as remaining in bed awake for long periods of time, often resulting in increased efforts to sleep, heightened frustration and anxiety about not sleeping, further wakefulness and negative expectations, and distorted beliefs and attitudes concerning the disorder and its consequences. Negative learned responses may


Figure 1—AlgorithmfortheEvaluationofChronicInsomnia.Whenusingthisdiagram,theclinicianshouldbeawarethatthepresenceofonediagnosis does not exclude other diagnoses in the same or another tier, as multiple diagnoses may coexist. Acute Adjustment Insomnia, not a chronic insomnia, is included in the chronic insomnia algorithm in order to highlight that the clinician should be aware that extrinsic stressors may trigger, perpetuate, or exacerbate the chronic insomnia.

No

No

Consider Behaviorally Induced Insufficient Sleep

Consider Short Sleeper

Yes

Consider Other/ Unspecified Insomnia; Re-evaluate for other occult or

comorbid disorders

Abnormal pattern of sleep-wake timing

Medications, substances temporally related to insomnia

-Restless Legs symptoms-Snoring , breathing symptoms-Abnormal sleep movements-Daytime sleepiness

Psychiatric disorder temporally related to insomnia

Medical disorder temporally related to insomnia

Yes No Yes No NoYes Yes No Yes No

Consider Circadian Rhythm Sleep Disorder

Consider Insomnia due to Mental Disorder

Consider Insomnia due to Medical Condition

Consider Insomnia due to Drug, Substance, or

Alcohol

Consider Restless Legs Syndrome , Periodic Limb Movement Disorder , Sleep Related Breathing Disorder ,

Parasomnias

Marked subjective-objective mismatch, extreme sleep symptoms

Behaviors and practices incompatible with good sleep

Presence of acute environmental, physical, or social stress

Conditioned arousal, learned sleep-preventing associations

Childhood onset, no precipitant

Yes No Yes No NoYes Yes No Yes No

Consider Paradoxical Insomnia

Consider Inadequate Sleep Hygiene

Consider Adjustment Insomnia

Consider Psychophysiological

Insomnia

Consider Idiopathic Insomnia

Complaint of difficulty falling sleep , difficulty maintaining sleep, nonrestorative sleep

Adequate opportunity and circumstances for sleep

Waking symptoms: Fatigue/ lethargy; concentration/ attention; memory; mood; psychomotor; physical

Insomnia Disorder

Comorbid Insomnia Disorders

Primary Insomnia Disorders

*Assess each category*

*Assess each category*


thepatient’ssenseofself-efficacywithrespecttomanagementofinsomnia.Theseobjectivesareaccomplishedby:

I. Identifying the maladaptive behaviors and cognitions that perpetuatechronicinsomnia;

II.Bringingthecognitivedistortionsinherentinthiscondi-tion to the patient’s attention and working with the patient to re-structure these cognitions into more sleep-compatible thoughts andattitudes;

III.Utilizingspecificbehavioralapproachesthatextinguishthe association between efforts to sleep and increased arousal by minimizing the amount of time spent in bed awake, while

ability to sleep and the daytime consequences of poor sleep, dis-torted beliefs and attitudes about the origins and meaning of the insomnia, maladaptive efforts to accommodate to the condition (e.g., schedule or lifestyle changes), and excessive time spentawakeinbed.Thelatterbehaviorisofparticularsignificanceinthat itoften isassociatedwith“tryinghard” to fall asleepandgrowingfrustrationandtensioninthefaceofwakefulness.Thus,the bed becomes associated with a state of waking arousal as this conditioning paradigm repeats itself night after night.

An implicit objective of psychological and behavioral thera-py is a change in belief system that results in an enhancement of

Table 9—ICSD-2Insomnias

Disorder DescriptionAdjustment(Acute)Insomnia Theessentialfeatureofthisdisorderisthepresenceofinsomniainassociationwithaniden-

tifiable stressor, such as psychosocial, physical, or environmental disturbances.The sleepdisturbancehasarelativelyshortduration(days-weeks)andisexpectedtoresolvewhenthestressor resolves.

PsychophysiologicalInsomnia Theessentialfeaturesofthisdisorderareheightenedarousalandlearnedsleep-preventingas-sociations. Arousal may be physiological, cognitive, or emotional, and characterized by muscle tension,“racingthoughts,”orheightenedawarenessoftheenvironment.Individualstypicallyhaveincreasedconcernaboutsleepdifficultiesandtheirconsequences,leadingtoa“viciouscycle”ofarousal,poorsleep,andfrustration.

ParadoxicalInsomnia Theessentialfeatureofthisdisorderisacomplaintofsevereornearly“total”insomniathatgreatly exceeds objective evidence of sleep disturbance and is not commensurate with the re-porteddegreeofdaytimedeficit.Althoughparadoxicalinsomniaisbestdiagnosedwithcon-currentPSGandself-reports,itcanbepresumptivelydiagnosedonclinicalgroundsalone.Tosomeextent, “misperception”of the severityof sleepdisturbancemaycharacterizeallinsomnia disorders.

IdiopathicInsomnia Theessentialfeatureofthisdisorderisapersistentcomplaintofinsomniawithinsidiouson-set during infancy or early childhood and no or few extended periods of sustained remission. Idiopathicinsomniaisnotassociatedwithspecificprecipitatingorperpetuatingfactors.

InsomniaDuetoMentalDisorder Theessentialfeatureofthisdisorderistheoccurrenceofinsomniathatoccursexclusivelyduringthecourseofamentaldisorder,andisjudgedtobecausedbythatdisorder.Theinsom-niaisofsufficientseveritytocausedistressortorequireseparatetreatment.Thisdiagnosisisnot used to explain insomnia that has a course independent of the associated mental disorder, asisnotroutinelymadeinindividualswiththe“usual”severityofsleepsymptomsforanassociated mental disorder.

InadequateSleepHygiene Theessentialfeatureofthisdisorderisinsomniaassociatedwithvoluntarysleeppracticesoractivitiesthatareinconsistentwithgoodsleepqualityanddaytimealertness.Thesepracticesand activities typically produce increased arousal or directly interfere with sleep, and may include irregular sleep scheduling, use of alcohol, caffeine, or nicotine, or engaging in non-sleepbehaviorsinthesleepenvironment.Someelementofpoorsleephygienemaycharacter-ize individuals with other insomnia disorders.

InsomniaDuetoaDrugorSubstance Theessentialfeatureofthisdisorderissleepdisruptionduetouseofaprescriptionmedica-tion, recreational drug, caffeine, alcohol, food, or environmental toxin. Insomnia may occur duringperiodsofuse/exposure,orduringdiscontinuation.Whentheidentifiedsubstanceisstopped, and after discontinuation effects subside, the insomnia is expected to resolve or sub-stantially improve.

InsomniaDuetoMedicalCondition Theessential featureof thisdisorder is insomniacausedbyacoexistingmedicaldisorderor other physiological factor. Although insomnia is commonly associated with many medi-cal conditions, this diagnosis should be used when the insomnia causes marked distress or warrantsseparateclinicalattention.Thisdiagnosisisnotusedtoexplaininsomniathathasacourse independent of the associated medical disorder, and is not routinely made in individu-alswiththe“usual”severityofsleepsymptomsforanassociatedmedicaldisorder.

InsomniaNotDuetoSubstanceorKnown ThesetwodiagnosesareusedforinsomniadisordersthatcannotbeclassifiedelsewherebutPhysiologicCondition,Unspecified; aresuspectedtoberelatedtounderlyingmentaldisorders,psychologicalfactors,behaviors,Physiologic(Organic)Insomnia, medicaldisorders,physiologicalstates,orsubstanceuseorexposure.ThesediagnosesareUnspecified typicallyusedwhenfurtherevaluationisrequiredtoidentifyspecificassociatedconditions,

orwhenthepatientfailstomeetcriteriaforamorespecificdisorder.



Psychological and behavioral therapies for insomnia include a number of different specificmodalities (Table 11).Currentdatasupporttheefficacyofstimulus control, relaxation train-ing, and cognitive behavioral therapy (CBT-1) (i.e.,multimodalapproaches that include both cognitive and behavioral ele-ments)with or without relaxation therapy.Thesetreatmentsarerecommended as a standard of care for the treatment of chronic

simultaneously promoting the desired association of bed with relaxationandsleep;

IV.Establishingaregularsleep-wakeschedule,healthysleephabitsandanenvironmentconducivetogoodsleep;and

V.Employingotherpsychologicalandbehavioraltechniquesthat diminish general psychophysiological arousal and anxiety about sleep.

Figure 2—AlgorithmfortheTreatmentofChronicInsomnia

Insomnia Disorder

Insomnia comorbid with other sleep disorder

“Primary” insomnias

Insomnia comorbid with medical, psychiatric , drug

Optimize treatment for other sleep

disorder

Improved Not improved

Optimize treatment for comorbid

disorder

Not improved Improved

Evaluate insomnia treatment options (cost, preference,

availability )

Psychological and behavioral treatment

Pharmacologic treatment

Combined treatment


CBT

Other behavioral treatment 1

Consider switching to other modality or

combined treatment--------------------------------

Reconsider diagnosis

Re-evaluate especially for occult or comorbid

disorders


Other behavioral treatment 2

BzRA orramelteon


Different BzRA or

ramelteon


Sedating antidepressant


BzRA + sedating antidepressant

Ongoing follow-up for efficacy, side effects, optimal

duration/ discontinuation


Follow-up with periodic review of efficacy , review of

tx principles




time. Factors in selecting a pharmacological agent should be directedby:(1)symptompattern;(2)treatmentgoals;(3)pasttreatmentresponses;(4)patientpreference;(5)cost;(6)avail-abilityofother treatments; (7) comorbidconditions; (8) con-traindications;(9)concurrentmedicationinteractions;and(10)side effects. An additional goal of pharmacologic treatment is to achieve a favorable balance between therapeutic effects and potential side effects.CurrentFDA-approvedpharmacologictreatmentsforinsom-

nia include several BzRAs and amelatonin receptor agonist(Table 12). SpecificBzRAs differ from each other primarilyin terms of pharmacokinetic properties, although some agents are relativelymore selective than others for specific gammaamino-butyricacid(GABA)receptorsubtypes.Theshort-termefficacyofBzRAshavebeendemonstratedinalargenumberof randomized controlled trials. A smaller number of controlled trials demonstrate continued efficacy over longer periods oftime.PotentialadverseeffectsofBzRAsincluderesidualseda-tion, memory and performance impairment, falls, undesired be-haviors during sleep, somatic symptoms, and drug interactions. A large number of other prescription medications are used off-label to treat insomnia, including antidepressant and anti-ep-ilepticdrugs.Theefficacyandsafetyfortheexclusiveuseofthese drugs for the treatment of chronic insomnia is not well documented. Many non-prescription drugs and naturopathicagents are also used to treat insomnia, including antihistamines, melatonin, and valerian.Evidence regarding the efficacy andsafety of these agents is limited.The following recommendations primarily pertain to pa-

tients with diagnoses of Psychophysiological, Idiopathic, and ParadoxicalInsomniainICSD-2,or thediagnosisofPrimaryInsomniainDSM-IV.Whenpharmacotherapyisutilized,treat-ment recommendations are presented in sequential order.

I. Short/intermediate-acting BzRAs or ramelteon:* Ex-amples of short/intermediate-actingBzRAs include zaleplon,zolpidem,eszopiclone,triazolam,andtemazepam.Nospecificagent within this group is recommended as preferable to the others inageneralsense;eachhasbeenshowntohaveposi-tive effects on sleep latency,TST, and/orWASO in placebo-controlled trials.32-37However,individualpatientsmayresponddifferentially to different medications within this class. Factors including symptom pattern, past response, cost, and patient preferenceshouldbeconsidered inselectingaspecificagent.For example, zaleplon and ramelteon have very short half-lives and consequently are likely to reduce sleep latency but have littleeffectonwakingaftersleeponset(WASO);theyarealsounlikelytoresultinresidualsedation.Eszopicloneandtemaze-pam have relatively longer half-lives, are more likely to im-prove sleep maintenance, and are more likely to produce re-sidual sedation, although such residual activity is still limited toaminorityofpatients.Triazolamhasbeenassociatedwithreboundanxietyandasa result, isnot consideredafirst linehypnotic.PatientswhoprefernottouseaDEA-scheduleddrug,and patients with a history of substance use disorders may be appropriate candidates for ramelteon, particularly if the com-plaintisthatofsleepinitiationdifficulty.

II. Alternative BzRAs or ramelteon: In the event that a pa-tient does not respond well to the initial agent, a different agent withinthesameclassisappropriate.Selectionofthealternative

insomnia. Although other modalities are common and useful with proven effectiveness, the level of evidence is not as strong for psychological and behavioral treatments including sleep re-striction, paradoxical intention, or biofeedback.Simpleeduca-tionregardingsleephygienealonedoesnothaveproveneffi-cacyforthetreatmentofchronicinsomnia.Inpractice,specificpsychological and behavioral therapies are most often combined asamulti-modaltreatmentpackagereferredtoasCBT-I.CBT-Imay also include the use of light and dark exposure, tempera-ture, and bedroom modifications. Other nonpharmacologicaltherapies such as light therapy may help to establish or rein-force a regular sleep-wake schedule with improvement of sleep quality and timing. A growing data base also suggests longer-termefficacyofpsychologicalandbehavioraltreatments.Whenaninitialpsychological/behavioraltreatmenthasbeen

ineffective, other psychological/ behavioral therapies, combi-nationCBT-I therapies, or combined treatmentwith pharma-cologicaltherapy(seebelow)maybeapplied.Additionally,thepresence of occult comorbid disorders should be considered.

Psychologists and other clinicians with more general cogni-tive-behavioral training may have varying degrees of experi-ence in behavioral sleep treatment. Such treatment is ideallydeliveredbyaclinicianwhoisspecificallytrainedinthisareasuchasabehavioralsleepmedicinespecialist.TheAmericanAcademyofSleepMedicinehasestablishedastandardizedpro-cessforCertificationinBehavioralSleepMedicine.30,31Howev-er, this level of care may not be available to all patients. Also of note,thetypeofadministration(individualversusgroup)andtreatmentschedule(suchaseveryonetotwoweeksforseveralsessions)mayvarybetweenproviders.Giventhecurrentshort-age of trained sleep therapists, on-site staff training and alterna-tivemethodsoftreatmentandfollow-up(suchastelephonere-viewofelectronically-transferredsleeplogsorquestionnaires),although unvalidated, may offer temporary options for access to treatment for this common and chronic disorder.

pharmacological Therapies

Thegoalsofpharmacologictreatmentaresimilartothoseofbehavioraltherapies:toimprovesleepqualityandquantity,toenhance associated daytime function, to reduce sleep latency and wakefulness after sleep onset, and to increase total sleep

Table 10—TreatmentGoals

1. PrimaryGoals:• Improvementinsleepqualityand/ortime.• Improvementofinsomnia-relateddaytimeimpairmentssuch

asimprovementofenergy,attentionormemorydifficulties,cognitive dysfunction, fatigue, or somatic symptoms.

2. OtherGoals:• Improvement in an insomnia symptom (SOL, WASO, #

awakenings)suchas:o SOL<30minutesand/oro WASO<30minutesand/oro Decreasedfrequencyofawakeningsorothersleepcom-

plaints o TST>6hoursand/orsleepefficiency>80%to85%.

• Formationof a positive and clear associationbetween thebed and sleeping

• Improvementinsleeprelatedpsychologicaldistress



beconsidered.Examplesofthesedrugsincludetrazodone,mir-tazapine, doxepin, amitriptyline, and trimipramine. Evidencefortheirefficacywhenusedaloneisrelativelyweak38-42 and no specificagentwithinthisgroupisrecommendedaspreferableto the others in this group. Factors such as treatment history, coexisting conditions (e.g. major depressive disorder), spe-cificsideeffectprofile,cost,andpharmacokineticprofilemayguidetheselectionofaspecificagent.Forexample,trazodonehas little or no anticholinergic activity relative to doxepin and amitriptyline, and mirtazapine is associated with weight gain. Note that low-dose sedating antidepressants do not constitute adequate treatment of major depression for individuals with co-morbidinsomnia.However,theefficacyoflow-dosetrazodoneas a sleep aid in conjunction with another full-dose antidepres-

drugshouldbebasedonthepatient’sresponsetothefirst.Forinstance,apatientwhocontinuestocomplainofWASOmightbeprescribedadrugwithalongerhalf-life;apatientwhocom-plains of residual sedation might be prescribed a shorter-acting drug.ThechoiceofaspecificBzRAmayincludelonger-actinghypnotics, such as estazolam. Flurazepam is rarely prescribed because of its extended half life. Benzodiazepines not spe-cificallyapprovedforinsomnia(e.g.,lorazepam,clonazepam)might also be considered if the duration of action is appropriate for the patient’s presentation or if the patient has a comorbid conditionthatmightbenefitfromthesedrugs.

III. Sedating low-dose antidepressant (AD): When ac-companied with comorbid depression or in the case of other treatment failures, sedating low-dose antidepressants may next

Table 11—CommonCognitiveandBehavioralTherapiesforChronicInsomnia

Stimulus control (Standard) is designed to extinguish the negative association between the bed and undesirable outcomes such as wakeful-ness,frustration,andworry.Thesenegativestatesarefrequentlyconditionedinresponsetoeffortstosleepasaresultofprolongedperiodsoftimeinbedawake.Theobjectivesofstimuluscontroltherapyareforthepatienttoformapositiveandclearassociationbetweenthebedandsleep and to establish a stable sleep-wake schedule.

Instructions:Gotobedonlywhensleepy;maintainaregularschedule;avoidnaps;usethebedonlyforsleep;ifunabletofallasleep(orbacktosleep)within20minutes,removeyourselffrombed—engageinrelaxingactivityuntildrowsythenreturntobed—repeatthisasnecessary.Patients should be advised to leave the bed after they have perceived not to sleep within approximately20minutes,ratherthanactualclock-watching which should be avoided.

Relaxation training (Standard) such as progressive muscle relaxation, guided imagery, or abdominal breathing, is designed to lower somatic and cognitive arousal states which interfere with sleep. Relaxation training can be useful in patients displaying elevated levels of arousal and isoftenutilizedwithCBT.

Instructions:Progressivemusclerelaxationtraininginvolvesmethodicaltensingandrelaxingdifferentmusclegroupsthroughoutthebody.Specifictechniquesarewidelyavailableinwrittenandaudioform.

Cognitive Behavioral Therapy for Insomnia or CBT-I (Standard) is a combination of cognitive therapy coupled with behavioral treatments (e.g.,stimuluscontrol,sleeprestriction)withorwithoutrelaxationtherapy.Cognitivetherapyseekstochangethepatient’sovervaluedbeliefsandunrealisticexpectationsaboutsleep.Cognitivetherapyusesapsychotherapeuticmethodtoreconstructcognitivepathwayswithpositiveandappropriateconceptsaboutsleepanditseffects.Commoncognitivedistortionsthatareidentifiedandaddressedinthecourseoftreatmentinclude:“Ican’tsleepwithoutmedication,”“Ihaveachemicalimbalance,”“IfIcan’tsleepIshouldstayinbedandrest,”“MylifewillberuinedifIcan’tsleep.”

Multicomponent therapy [without cognitive therapy] (Guideline) utilizesvariouscombinationsofbehavioral(stimuluscontrol,relaxation,sleeprestriction)therapies,andsleephygieneeducation.Manytherapistsusesomeformofmultimodalapproachintreatingchronicinsomnia.

Sleep restriction (Guideline) initiallylimits thetimeinbedtothetotalsleeptime,asderivedfrombaselinesleeplogs.Thisapproachisintended to improve sleep continuity by using sleep restriction to enhance sleep drive. As sleep drive increases and the window of oppor-tunityforsleepremainsrestrictedwithdaytimenappingprohibited,sleepbecomesmoreconsolidated.Whensleepcontinuitysubstantiallyimproves,timeinbedisgraduallyincreased,toprovidesufficientsleeptimeforthepatienttofeelrestedduringtheday,whilepreservingthenewly acquired sleep consolidation. In addition, the approach is consistent with stimulus control goals in that it minimizes the amount of time spent in bed awake helping to restore the association between bed and sleeping.

Instructions (Note, when using sleep restriction, patients should be monitored for and cautioned about possible sleepiness):Maintainasleeploganddeterminethemeantotalsleeptime(TST)forthebaselineperiod(e.g.,1-2weeks)Setbedtimeandwake-uptimestoapproximatethemeanTSTtoachievea>85%sleepefficiency(TST/TIB×100%)over7days;thegoal

isforthetotaltimeinbed(TIB)(not<5hours)toapproximatetheTST.Makeweeklyadjustments:1)forsleepefficiency(TST/TIB×100%)>85%to90%over7days,TIBcanbeincreasedby15-20minutes;

2)forSE<80%,TIBcanbefurtherdecreasedby15-20minutes.RepeatTIBadjustmentevery7days.

Paradoxical intention (Guideline) isaspecificcognitivetherapyinwhichthepatientistrainedtoconfrontthefearofstayingawakeanditspotentialeffects.Theobjectiveistoeliminateapatient’sanxietyaboutsleepperformance.

Biofeedback therapy (Guideline) trainsthepatienttocontrolsomephysiologicvariablethroughvisualorauditoryfeedback.Theobjectiveis to reduce somatic arousal.

Sleep hygiene therapy (No recommendation) involves teaching patients about healthy lifestyle practices that improve sleep. It should be used in conjunction with stimulus control, relaxation training, sleep restriction or cognitive therapy.Instructions include, but are not limited to, keeping a regular schedule, having a healthy diet and regular daytime exercise, having a quiet sleep environment,andavoidingnapping,caffeine,otherstimulants,nicotine,alcohol,excessivefluids,orstimulatingactivitiesbeforebedtime.



Table 12—PharmaceuticalTherapyOptions

Drug Dosage Form Recommended Dosage Indications/Specific Comments

Benzodiazepine Receptor Agonistic Modulators (Schedule IV Controlled Substances)

Non-benzodiazepines

cyclopyrrolones eszopiclone 1,2,3mgtablets 2-3mghs

1mghsinelderlyordebilitated;max2mg1mghsinseverehepaticimpairment;max2mg

Primarily used for sleep-onset and main-tenanceinsomnia;

Intermediate-acting; No short-term usage restriction

imidazopyridines zolpidem

zolpidem(controlledrelease)

5,10mgtablets

6.25,12.5mgtablets

10mghs;max10mg5mghsinelderly,debilitated,orhepaticimpairment12.5mghs6.25mghsinelderly,debilitated,orhepaticimpairment

Primarily used for sleep-onset insomnia Short-tointermediate-acting

Primarily used for sleep-onset and main-tenanceinsomnia;

Controlled release; swallowwhole,notdivided, crushed or chewed

pyrazolopyrimidines zaleplon 5,10mgcapsules 10mghs;max20mg

5mghsinelderly,debilitated,mildtomoderate hepatic impairment, or concomitant cimetidine

Primarily used for sleep onset insomnia Maintenanceinsomniaaslongas4hours

is available for further sleep Short-acting

Benzodiazepines

estazolam 1,2mgtablets 1-2mghs0.5mghsinelderlyordebilitated Short-tointermediate-acting

temazepam 7.5,15,30mgcapsules

15-30mghs7.5mghsinelderlyordebilitated Short-tointermediate-acting

triazolam 0.125,0.25mgtablets

0.25mghs;max0.5mg0.125mghsinelderlyordebilitated;max0.25mg

Short-acting

flurazepam 15,30mgcapsules 15-30mghs15mghsinelderlyordebilitated

Long-acting Risk of residual daytime drowsiness

Melatonin Receptor Agonists (Non-Scheduled)

ramelteon 8mgtablet 8mghs Primarily used for sleep-onset insomnia Short-acting No short-term usage restriction

Tablepartiallyconstructedfromindividualdrugprescribinginformationlabeling.Seeproductlabelingforcompleteprescribinginformation.TheFDArecentlyrecommendedthatawarningbeissuedregardingadverseeffectsassociatedwithBzRAhypnotics.Thesemedicationshavebeen associated with reports of disruptive sleep related behaviors including sleepwalking, eating, driving, and sexual behavior. Patients should be cautioned about the potential for these adverse effects, and about the importance of allowing appropriate sleep time, using only prescribed dosesandavoidingthecombinationofBzRAhypnoticswithalcohol,othersedatives,andsleeprestriction.Generalcommentsaboutsedatives/hypnotics:• Administrationonanemptystomachisadvisedtomaximizeeffectiveness.• Notrecommendedduringpregnancyornursing.• Cautionisadvisedifsigns/symptomsofdepression,compromisedrespiratoryfunction(e.g.,asthma,COPD,sleepapnea),orhepaticheart

failure are present.• Cautionanddownwarddosageadjustmentisadvisedintheelderly.• Safety/effectivenessinpatients<18yearsnotestablished• AdditiveeffectonpsychomotorperformancewithconcomitantCNSdepressantsand/oralcoholuse.• Rapiddosedecreaseorabruptdiscontinuanceofbenzodiazepinescanproducewithdrawalsymptoms,includingreboundinsomnia,similar

to that of barbiturates and alcohol.Certainantidepressants(amitriptyline,doxepin,mirtazapine,paroxetine,trazodone)areemployedinlowerthanantidepressanttherapeuticdos-agesforthetreatmentofinsomnia.ThesemedicationsarenotFDAapprovedforinsomniaandtheirefficacyforthisindicationisnotwellestab-lished.OTCsleepmedicationscontainantihistaminesastheprimaryagent;efficacyfortreatmentofinsomniaisnotwellestablished,especiallyitslong-term use.



limited efficacyof these substances andpossible interactionswith their comorbid conditions and concurrent medications.

pharmacological Treatment Failure

Although medications can play a valuable role in the man-agement of insomnia, a subset of chronic insomnia patients may have limited or only transient improvement with medication. As recommended,alternativetrialsorcombinationsmaybeuseful;however, clinicians should note that if multiple medication tri-als have proven ultimately ineffective, cognitive behavioral ap-proaches should be pursued in lieu of or as an adjunct to further pharmacological trials. Additionally, the diagnosis of comorbid orotherinsomniasshouldbereconsidered.Cautionisadvisedregarding polypharmacy, particularly in patients who have not or will not pursue psychological and behavioral treatments.

Mode of Administration/Treatment

Frequency of administration of hypnotics depends on the specific clinical presentation; empirical data support bothnightlyandintermittent(2-5timesperweek)administration.49-51Manycliniciansrecommendschedulednon-nightlydosingatbedtime as a means of preventing tolerance, dependence, and abuse, although these complications may be less likely with newerBzRAagents.Afinal strategy sometimes employed inclinicalpractice is true“asneeded”dosingwhen thepatientsawakensfromsleep.Thisstrategyhasnotbeencarefullyinves-tigated, and is not generally recommended due to the potential for carry-over sedation the next morning and the theoretical potential for inducing conditioned arousals in anticipation of a medication dose.

Durationoftreatmentalsodependsonspecificclinicalchar-acteristicsandpatientpreferences.FDAclasslabelingforhyp-notics prior to 2005 implicitly recommended short treatmentduration;since2005,hypnoticlabelingdoesnotaddressdura-tion of treatment. Antidepressants and other drugs commonly usedoff-labelfortreatmentofinsomniaalsocarrynospecificrestrictions with regard to duration of use. In clinical practice, hypnotic medications are often used over durations of one to twelve months without dosage escalation,52-55 but the empiri-cal data base for long-term treatment remains small. Recent randomized, controlled studies of non-BZD-BzRAs (such aseszopicloneorzolpidem)havedemonstratedcontinuedefficacywithout significant complications for 6months, and in open-labelextensionstudiesfor12monthsorlonger.Formanypatients,an initial treatmentperiodof2-4weeks

may be appropriate, followed by re-evaluation of the contin-ued need for treatment. A subset of patients with severe chron-ic insomnia may be appropriate candidates for longer-term or chronicmaintenancetreatment,but,asstated,thespecificdefin-ingcharacteristicsofthesepatientsareunknown.Thereislittleempirical evidence available to guide decisions regarding which drugs to use long-term, either alone or in combination with be-havioral treatments.Thus,guidelinesfor long-termpharmaco-logical treatment need to be based primarily on common clinical practice and consensus. If hypnotic medications are used long-term, regular follow-up visits should be scheduled at least every sixmonthsinordertomonitorefficacy,sideeffects,tolerance,

sant medication has been assessed in a number of studies of patients with depressive disorders. These studies, of varyingqualityanddesign,suggestmoderateefficacyfortrazodoneinimproving sleep quality and/or duration. It is unclear to what extentthesefindingscanbegeneralizedtootherpresentationsof insomnia.

IV. Combination of BzRA + AD: No research studies have been conducted to specifically examine such combinations,but a wealth of clinical experience with the co-administration ofthesedrugssuggeststhegeneralsafetyandefficacyofthiscombination. A combination of medications from two different classesmayimproveefficacybytargetingmultiplesleep-wakemechanisms while minimizing the toxicity that could occur withhigherdosesofasingleagent.SideeffectsarelikelytobeminimizedfurtherbyusingthelowdosesofADtypicalinthetreatment of insomnia, but potential daytime sedation should be carefully monitored.

V. Other prescription drugs:Examplesincludegabapentin,tiagabine,quetiapine,andolanzapine.Evidenceofefficacyforthese drugs for the treatment of chronic primary insomnia is in-sufficient.Avoidanceofoff-labeladministrationofthesedrugsis warranted given the weak level of evidence supporting their efficacyforinsomniawhenusedaloneandthepotentialforsig-nificantsideeffects(e.g.,seizureswithtiagabine;neurologicalside effects, weight gain, and dysmetabolism with quetiapine andolanzapine).

VI. Prescription drugs- Not recommended: Although chloralhydrate,barbiturates,and“non-barbituratenon-benzo-diazepine”drugs(suchasmeprobamate)areFDA-approvedforinsomnia, they are not recommended for the treatment of in-somnia,giventheirsignificantadverseeffects,lowtherapeuticindex, and likelihood of tolerance and dependence.

VII. Over-the-counter agents: Antihistamines and antihis-tamine-analgesic combinations are widely used self-remedies for insomnia. Evidence for their efficacy and safety is verylimited,withveryfewavailablestudiesfromthepast10yearsusing contemporary study designs and outcomes.43 Antihista-mines have the potential for serious side effects arising from their concurrent anticholinergic properties. Alcohol, likely the most common insomnia self-treatment, is not recommended be-cause of its short duration of action, adverse effects on sleep, exacerbation of obstructive sleep apnea, and potential for abuse anddependence.Veryfewherbaloralternativetreatmentshavebeen systematically evaluated for the treatment of insomnia. Of these, the greatest amount of evidence is available regarding valerian extracts and melatonin.44-47 Available evidence sug-gests that valerian has small but consistent effects on sleep la-tency, with inconsistent effects on sleep continuity, sleep dura-tion,andsleeparchitecture.Melatoninhasbeentestedinalargenumberofclinicaltrials.Meta-analyseshavedemonstratedthatmelatonin has small effects on sleep latency, with little effect onWASOorTST.Itshouldbenotedthatsomeofthepublishedtrialsofmelatoninhaveevaluateditsefficacyasachronobiotic(phase-shiftingagent)ratherthanasahypnotic.Long-termuseofnon-prescription(over-the-counter)treat-

mentsisnotrecommended.Efficacyandsafetydataformostover-the-counter insomnia medications is limited to short-term studies;theirsafetyandefficacyinlong-termtreatmentisun-known.48 Patients should be educated regarding the risks and



thelongertermwithoutsignificantcomplications.Thesefacts,however, do not provide the clinician with a clear set of practice standards, particularly when it comes to sequencing or combi-nationoftherapies.Theliteraturethathasexaminedtheissueof individual pharmacotherapy or cognitive behavioral treat-ment versus a combination of these approaches demonstrates that short-term pharmacological treatments alone are effective during the course of treatment for chronic insomnia but do not provide sustained improvement following discontinuation,65,66 whereas cognitive behavioral treatments produce significantimprovement of chronic insomnia in the short-term, and these improvements appear sustained at follow-up for up to two years.67Studiesofcombinedtreatmentshowmixedandincon-clusive results.Takenasawhole, these investigationsdonotdemonstrate a clear advantage for combined treatment over cognitive behavioral treatment alone.65,66,68-70

DISClOSURE STATEMENT

Thiswas not an industry supported study.Dr.Buysse hasconsulted to and/or been on the advisory board of Actelion, Arena,Cephalon,EliLilly,GlaxoSmithKline,Merck,Neuro-crine,Neurogen,Pfizer,Respironics,Sanofi-Aventis,Sepracor,Servier,SomnusTherapeutics,StressEraser,Takeda,andTran-sceptPharmaceuticals.Theotherauthorshaveindicatednofi-nancialconflictsofinterest.

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On discontinuation of hypnotic medication after more than a fewdays’use,reboundinsomnia(worseningofsymptomswithdosereduction,typicallylasting1-3days),potentialphysicalaswell as psychological withdrawal effects, and recurrence of in-somnia may all occur.56 Rebound insomnia and withdrawal can be minimized by gradually tapering both the dose and frequency of administration.57 In general, the dose should be lowered by the smallest increment possible in successive steps of at least several days’duration.Taperingthefrequencyofadministration(suchaseveryotheroreverythirdnight)hasalsobeenshowntominimizereboundeffects.Successfultaperingmayrequireseveralweeksto months. As noted elsewhere, tapering and discontinuation of hypnotic medication is facilitated by concurrent application of cognitive-behavioral therapies, which increase rates of success-ful discontinuation and duration of abstinence.58,59

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Evaluation and Management of Chronic Insomnia in Adults

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