Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults - 2008

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) • The sleep history should cover specific insomnia com- plaints, pre-sleep conditions, sleep-wake patterns, oth- er sleep-related symptoms, and daytime consequences. (Consensus) • The history helps to establish the type and evolution of insomnia, perpetuating factors, and identification of comorbid 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) • At minimum, the patient should complete: (1) A gen- eral medical/psychiatric questionnaire to identify co- morbid disorders (2) The Epworth Sleepiness Scale or other sleepiness assessment to identify sleepy patients and comorbid disorders of sleepiness (3) A two-week sleep log to identify general patterns of sleep-wake times and day-to-day variability. (Consensus) • Sleep diary data should be collected prior to and dur- ing the course of active treatment and in the case of relapse or reevaluation in the long-term. (Consensus) • Additional assessment instruments that may aid in the baseline 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) are not indicated in the routine evaluation of chronic insomnia, including insomnia due to psychiatric or neuropsychiatric disorders. (Standard) • Polysomnography is indicated when there is reason- able clinical suspicion of breathing (sleep apnea) or movement disorders, when initial diagnosis is uncer- tain, treatment fails (behavioral or pharmacologic), or precipitous arousals occur with violent or injurious behavior. (Guideline) Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults Sharon 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, 2008 Accepted for publication July, 2008 Address 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: rodins@hphs.upenn.edu 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. Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 488 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)  Other laboratory testing (e.g., blood, radiographic) is not in- dicated for the routine evaluation of chronic insomnia unless there is suspicion for comorbid disorders. (Consensus) Differential Diagnosis:  The presence of one insomnia disorder does not exclude other disorders, as multiple primary and comorbid insom- nia disorders may coexist. (Consensus) Treatment Goals/Treatment Outcomes:  Regardless of the therapy type, primary treatment goals are: (1) to improve sleep quality and quantity and (2) to improve insomnia related daytime impairments. (Consensus)  Other specific outcome indicators for sleep generally in- clude measures of wake time after sleep onset (WASO), sleep onset latency (SOL), number of awakenings, sleep time or sleep efficiency, formation of a positive and clear association between the bed and sleeping, and improve- ment of sleep related psychological distress. (Consensus)  Sleep diary data should be collected prior to and during the course of active treatment and in the case of relapse or reevaluation in the long term (every 6 months). (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 the insomnia appears stable or resolved, and then every 6 months, as the relapse rate for insomnia is high. (Consen- sus)  When a single treatment or combination of treatments has been 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 adults of all ages, including older adults, and chronic hypnotic users. (Standard) • These treatments should be utilized as an initial inter- 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- tive behavioral therapy for insomnia (CBT-I). (Standard)  Multicomponent therapy (without cognitive therapy) is effective 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, there is insufficient evidence to 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 has been ineffective, other psychological/ behavioral therapies, combination CBT-I therapies, combined treatments (see below), or occult comorbid disorders may next be consid- ered. (Consensus) pharmacological Treatment:  Short-term hypnotic treatment should be supplemented with behavioral and cognitive therapies when possible. (Consensus)  When pharmacotherapy is utilized, the choice of a specific pharmacological agent within a class, should be directed by: (1) symptom pattern; (2) treatment goals; (3) past treat- ment responses; (4) patient preference; (5) cost; (6) avail- ability of other treatments; (7) comorbid conditions; (8) contraindications; (9) concurrent medication interactions; and (10) side effects. (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 trials is: (Consensus) • Short-intermediate acting benzodiazepine receptor ago- nists (BZD or newer BzRAs) or ramelteon: examples of these medications include zolpidem, eszopiclone, zale- plon, and temazepam • Alternate short-intermediate acting BzRAs or ramelt- eon if the initial agent has been unsuccessful • Sedating antidepressants, especially when used in con- junction with treating comorbid depression/anxiety: examples of these include trazodone, amitriptyline, doxepin, and mirtazapine • Combined BzRA or ramelteon and sedating antide- pressant • Other sedating agents: examples include anti-epilepsy medications (gabapentin, tiagabine) and atypical an- tipsychotics (quetiapine and olanzapine)  These medications may only be suitable for pa- tients with comorbid insomnia who may benefit from the primary action of these drugs as well as from the sedating effect.  Over-the-counter antihistamine or antihistamine/analgesic type drugs (OTC “sleep aids”) as well as herbal and nu- tritional substances (e.g., valerian and melatonin) are not recommended in the treatment of chronic insomnia due to the relative lack of efficacy and safety data. (Consensus) Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 489 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)  The following guidelines apply to prescription of all medi- cations for management of chronic insomnia: (Consen- sus) • Pharmacological treatment should be accompanied by patient education regarding: (1) treatment goals and expectations; (2) safety concerns; (3) potential side effects and drug interactions; (4) other treatment mo- dalities (cognitive and behavioral treatments); (5) po- tential for dosage escalation; (6) rebound insomnia. • Patients should be followed on a regular basis, every few weeks in the initial period of treatment when pos- sible, to assess for effectiveness, possible side effects, and the need for ongoing medication. • Efforts should be made to employ the lowest effective maintenance dosage of medication and to taper medi- cation when conditions allow.  Medication tapering and discontinuation are fa- cilitated by CBT-I. • Chronic hypnotic medication may be indicated for long- term use in those with severe or refractory insomnia or chronic comorbid illness. Whenever possible, patients should receive an adequate trial of cognitive behavioral treatment during long-term pharmacotherapy.  Long-term prescribing should be accompanied by 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-term administration may be nightly, intermit- tent (e.g., three nights per week), or as needed. Combined Treatments:  The use of combined therapy (CBT-I plus medication) should be directed by (1) symptom pattern; (2) treatment goals; (3) past treatment responses; (4) patient preference; (5) cost; (6) availability of other treatments; (7) comorbid conditions; (8) contraindications; (9) concurrent medica- tion interactions; and (10) side effects. (Consensus)  Combined therapy shows no consistent advantage or dis- advantage over CBT-I alone. Comparisons to long-term pharmacotherapy alone are not available. (Consensus) INTRODUCTION Insomnia symptoms occur in approximately 33% to 50% of the adult population; insomnia symptoms with distress or im- pairment (general insomnia disorder) in 10% to 15%. Consistent risk factors for insomnia include increasing age, female sex, co- morbid (medical, psychiatric, sleep, and substance use) disor- ders, shift work, and possibly unemployment and lower socio- economic status. “Insomnia” has been used in different contexts to refer to either a symptom or a specific disorder. In this guide- line, an insomnia disorder is defined as a subjective report of difficulty with sleep initiation, duration, consolidation, or qual- ity that occurs despite adequate opportunity for sleep, and that results in some form of daytime impairment. Because insomnia may present with a variety of specific complaints and contribut- ing factors, the time required for evaluation and management of chronic insomnia can be demanding for clinicians. The purpose of 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 This clinical guideline includes both evidence-based and con- sensus-based recommendations. In the guideline summary rec- ommendation section, each recommendation is accompanied by its level of evidence: standard, guideline, option, or consensus based. “Standard,” “guideline,” and “option” recommendations were incorporated from evidence-based American Academy of Sleep Medicine (AASM) practice parameter papers. “Consen- sus” recommendations were developed using a modified nomi- nal group technique. The development of these recommenda- tions and their appropriate use are described below. Evidence-Based practice parameters In the development of this guideline, existing AASM prac- tice parameter papers relevant to the evaluation and manage- ment of chronic insomnia in adults were incorporated.2-6 These practice parameter papers, many of which addressed specific insomnia-related topics rather than providing a comprehensive clinical chronic insomnia practice guideline for clinicians, were previously developed via a computerized, systematic search of the scientific literature (for specific search terms and further de- tails, see referenced practice parameter) and subsequent critical review, evaluation, and evidence-grading of all pertinent stud- ies.7 On the basis of this review the AASM Standards of Practice Committee developed practice parameters. Practice parameters were designated as “Standard,” “Guideline,” or “Option” based on the quality and amount of scientific evidence available (Ta- ble 1). Consensus-Based Recommendations Consensus-based recommendations were developed for this clinical guideline to address important areas of clinical practice that had not been the subject of a previous AASM practice param- eter, or where the available empirical data was limited or incon- clusive. Consensus-based recommendations reflect the shared judgment of the committee members and reviewers, based on the literature and common clinical practice of topic experts, and were developed using a modified nominal group technique. An expert insomnia panel was assembled by the AASM to author this clinical guideline. In addition to using all AASM practice parameters and AASM Sleep publications through July 2007, the expert panel reviewed other relevant source articles from a Medline search (1999 to October 2006; all adult ages including seniors; “insomnia and” key words relating to evaluation, test- ing, and treatments. Using a face-to-face meeting, voting sur- Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 490 Table 2—Diagnostic Criteria for Insomnia (ICSD-2) A. A complaint of diffi culty initiating sleep, diffi culty maintain-A complaint of difficulty initiating sleep, difficulty maintain- ing sleep, or waking up too early, or sleep that is chronically nonrestorative or poor in quality. B. The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep. C. At least one of the following forms of daytime impairment re- lated to the nighttime sleep difficulty is reported by the patient: 1. Fatigue or malaise; 2. Attention, concentration, or memory impairment; 3. Social or vocational dysfunction or poor school performance; 4. Mood disturbance or irritability; 5. Daytime sleepiness; 6. Motivation, energy, or initiative reduction; 7. Proneness for errors/accidents at work or while driving; 8. Tension, headaches, or gastrointestinal symptoms in re- sponse to sleep loss; and 9. Concerns or worries about sleep. treatment options, resources available, and other relevant fac- tors. The AASM expects this clinical guideline to have an im- pact on professional behavior and patient outcomes. It reflects the 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 to either a symptom or a specific disorder. In this guideline, an insomnia disorder is defined as a subjective report of difficulty with sleep initiation, duration, consolidation, or quality that oc- curs despite adequate opportunity for sleep, and that result in some form of daytime impairment (Table 2). Except where otherwise noted, the word “insomnia” refers to an insomnia disorder in this guideline. Insomnia disorders have been categorized in various ways in different sleep disorder classification systems. The International Classification of Sleep Disorders, 2nd Edition (ICSD-2) is used as the basis for insomnia classification in this guideline. The ICSD-2 identifies insomnia as one of eight major categories of sleep disorders and, within this group, lists twelve specific in- somnia disorders (Table 3). ICSD-2 delineates both general diagnostic criteria that apply to all insomnia disorders, as well as more specific criteria for each 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 actual prevalence of insomnia varies according to the stringency of the definition used. Insomnia symptoms occur in approximately 33% to 50% of the adult population; insomnia symptoms with dis- tress or impairment (i.e., general insomnia disorder) in 10% to 15%; and specific insomnia disorders in 5% to 10%.10 Consis- tent risk factors for insomnia include increasing age, female sex, comorbid (medical, psychiatric, sleep, and substance use) disor- ders, shift work, and possibly unemployment and lower socio- economic status. Patients with com