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Draft Key Questions:
These questions were available for public comment from Oct. 25–Nov. 14, 2013
Insomnia Disorder: Diagnosis and Management Outside of Sleep Medicine Clinics
Draft Key Questions
- What are the efficacy and comparative effectiveness of treatments for insomnia disorder in subgroups of adults (e.g., older adults, elderly menopausal women, adults with comorbid conditions)?
- What are the efficacy and comparative effectiveness of combined treatments (e.g. cognitive behavioral therapy and drug therapy) for the treatment of insomnia disorder in adults?
- What are the long-term efficacy and comparative effectiveness of treatments for insomnia disorder in adults?
- What are the harms of treatments for insomnia disorder in subgroups of adults (e.g., older adults, elderly menopausal women, adults with comorbid conditions)?
- What are the harms of combined treatments (e.g. cognitive behavioral therapy and drug therapy) for insomnia disorder in adults?
- What are the long-term harms of treatments for insomnia disorder in adults?
Draft Analytic Framework
Figure 1. Analytic framework for diagnosis and treatment of insomnia disorder
Abbreviations: CAM = complementary and alternative medicine; KQ = key question; SM = sleep medicine
Individuals with insomnia typically report dissatisfaction with sleep quality or duration.1 Insomnia is characterized by difficulty falling asleep or maintaining sleep, waking frequently or waking too early without being able to return to sleep, or poor sleep quality or nonrestorative sleep.2 Daytime dysfunction that accompanies these sleep problems includes fatigue, poor cognitive function, mood disturbance, and distress or interference with personal functioning.1,2 When chronic, insomnia can last from months to years.3
Sleep disorders are a major burden to modern society. Estimates of the total annual costs of insomnia in the United States range between $30 and $107 billion.3 These include direct costs between $12 and $14 billion for expenses such as medical appointments, over-the-counter sleep aids, and prescription medication. The remainder includes indirect costs such as lost productivity due to presenteeism and absenteeism, reduced quality of life, and accidents and injuries.
Adults around the globe struggle to achieve an appropriate duration and/or quality of sleep. Insomnia is the most prevalent sleep disorder and one of the most common complaints for adults in primary care.1 Insomnia is associated with decline in overall health status and perception of poor health and can have negative personal and social consequences.6 Chronic insomnia may be associated with long-term health consequences such as increased morbidity, respiratory diseases, rheumatic diseases, cardiovascular diseases, cerebrovascular conditions, and diabetes.6
Prevalence estimates of insomnia vary greatly by how insomnia is defined in the original research and data source. Estimates range from nearly 33 percent in an international sample of patients of primary care practices to 17 percent of U.S. adults reporting “regularly having insomnia or trouble sleeping in the past 12 months” to 6–20 percent of adults meeting established diagnostic criteria.1,2,5 Insomnia is chronic in 40–70 percent of cases.2 Older adults and women have higher prevalence of insomnia, and about half of insomnia cases coexist with a psychiatric diagnosis.4 Aging is often accompanied by changes in sleep patterns (disrupted sleep, frequent wakening, and early wakening) that can lead to insomnia.8 Women are 1.4 times more at risk than men to suffer from insomnia, and menopause is a period when women are particularly prone to insomnia.9
While insomnia is quite prevalent, patients may not discuss these problems with primary care or mental health providers, and these providers typically have little training in identifying and treating the disorder.10 It is not clear what diagnostic criteria are used in primary care and other outpatient settings outside of sleep medicine clinics (e.g., general mental health clinics). Furthermore, there appears to be an over-reliance on pharmaceutical treatments, especially hypnotic medications, in these settings despite well-established shortcomings.10
Sleep medicine clinics are likely to use established criteria in diagnosing insomnia. However, these criteria continue to evolve as more research on insomnia becomes available. The diagnostic criteria for insomnia were specified in the International Classification of Sleep Disorders (ICSD-II) and the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders.3,4 These criteria recognize a sleep-related complaint combined with daytime dysfunction. Until recently, these diagnostic criteria had classified insomnia as primary or comorbid, depending upon the absence or presence of other conditions. However, the recently released 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (hereafter DSM-5) adopted the term ‘insomnia disorder’ and removed the distinction between primary and comorbid insomnia.11 The distinction had been of questionable relevance in clinical practice; revisions reflect this understanding and suggest diagnosing patients with “insomnia disorder” if they meet diagnostic criteria, despite any coexisting conditions. The upcoming revision to the International Classification of Sleep Disorders (ICSD-III) is expected to be consistent with the changes to the DSM-5.
Individuals suffering from insomnia tend to seek treatment when symptom severity (e.g., fatigue, daytime functioning, cognitive impairment) reach a bothersome level.3 Many interventions are available to treat chronic insomnia. These include over-the-counter medications and supplements, education on sleep hygiene, behavioral interventions, prescription medications, and complementary and alternative treatments. Insomnia is often treated with drugs. Several drugs are approved by the U.S. Food and Drug Administration for the treatment of insomnia (doxepin, estazolam, eszopiclone, flurazepam, quazepam, ramelteon, temazepam, triazolam, zaleplon, and zolpidem), although several other drugs from many drug classes have also been used to treat insomnia. While drugs produce short-term reduction of insomnia, medication-related adverse effects (e.g., dependence, abnormal sleep behaviors) exist, and nonpharmacological approaches (e.g., cognitive behavioral therapy) may lead to sustained resolution of insomnia after drug discontinuation.12 In contrast, insomnia symptoms often resume after discontinuation of pharmacotherapy.12 As such, cognitive behavioral therapy for insomnia (CBT-I) is now recommended as a first-line treatment for insomnia by the National Institutes of Health.13 Barriers to CBT exist, however, especially in primary care settings. These include a limited number of trained practitioners and the high costs associated with multiple followup visits. Patient preference also influences the utilization of CBT.
Combined (e.g., pharmacotherapy plus CBT) or stepped-care models (initiating one intervention followed by another modality) are currently advocated as the optimal approach. Combination therapy specifies the timing of certain intervention components.14 The stepped-care model has been described in terms of how limited CBT therapies could be utilized.15 These approaches are promising because they are designed to maximize treatment benefits while minimizing harms and to assist in efficient delivery of services at the level appropriate for the patient.
Treatment of insomnia in special populations (the elderly, menopausal women, pregnant women, and adults with learning disability) may differ from treatments for insomnia in the general adult population due to their enhanced susceptibility to medication harms and potentially contributing circumstances. Treating insomnia in patients with coexisting conditions may complicate treatment, especially when drug interventions are used.
There are many systematic reviews and randomized controlled trials on the treatment of insomnia. However, a focus on primary care and other non-sleep medicine settings is not as well represented as studies evaluating treatments in sleep medicine clinics.
Also missing in the currently available literature is a systematic review that addresses the broad range of interventions, with conclusions meaningful to guideline developers aimed at improving the identification and treatment of insomnia disorder in settings outside of sleep medicine clinics.
- Adults, age 18 and above, with insomnia disorder
- Subgroups of adults with insomnia disorder (older adults, elderly menopausal women, and adults with comorbid conditions)
- Diagnostic methods
- Types of treatment interventions
- Patient education
- Psychological interventions
- Pharmaceutical interventions
- Complementary and alternative medicine (CAM) interventions
- Placebo or active control
- Usual care
- Other intervention
- Key Question 1
- Diagnostic accuracy (i.e., the diagnosis agrees with ICSD-III/DSM-5 criteria)
- Key Question 2
- Intermediate outcomes
- Self-reported sleep measures (sleep duration, trouble falling asleep, night-time waking, nonrestorative sleep, and poor sleep quality)
- Self-reported daytime symptoms (fatigue, low energy, reduced cognitive functioning, and mood disturbances)
- Polysomnoagraphic assessments (sleep duration, latencies, and wakening after sleep onset)
- Changes in sleep scale scores
- Primary outcomes
- Clinically meaningful changes in (1) sleep scale scores and (2) quality of life scale scores
- Meaningful changes in daytime functional impairments
- Intermediate outcomes
- Key Question 3
- Any adverse effects of the intervention(s) (e.g., medication dependence, abnormal sleep behaviors
- Treatment duration of 3 months or more
- Primary care
- Other outpatient settings outside of sleep medicine clinics
* Findings will be applied to the settings listed; however, eligible studies may not be restricted to these settings.
- Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. PMID: 22265700.
- Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. PMID: 23423416.
- Kraus SS, Rabin LA. Sleep America: managing the crisis of adult chronic insomnia and associated conditions. J Affect Disord. 2012 May;138(3):192-212. PMID: 21652083.
- Wilson SJ, Nutt DJ, Alford C, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. PMID: 20813762.
- DynaMed™. Insomnia. 2013.
- Spanish National Health Service. Clinical Practice Guidelines for the Management of Patients with Insomnia in Primary Care. UETS No. 2007/5-1. Madrid, Spain: Ministry of Health and Social Policy; 2009. Available at http://www.guiasalud.es/GPC/GPC_465_Insomnia_Lain_Entr_compl_en.pdf.
- Buscemi N, Vandermeer B, Friesen C, et al. Manifestations and Management of Chronic Insomnia in Adults. Summary. Evidence Report/Technology Assessment No. 125 (Prepared by the University of Alberta Evidence-based Practice Center under Contract No. C400000021). AHRQ Publication No. 05-E021-2. Rockville, MD: Agency for Healthcare Research and Quality; 2005. Available at http://archive.ahrq.gov/downloads/pub/evidence/pdf/insomnia/insomnia.pdf.
- Rybarczyk B, Lund HG, Garroway AM, et al. Cognitive behavioral therapy for insomnia in older adults: background, evidence, and overview of treatment protocol. Clin Gerontologist. 2013 Jan;36(1):70-93. DOI: 10.1080/07317115.2012.731478.
- Xu M, Belanger L, Ivers H, et al. Comparison of subjective and objective sleep quality in menopausal and non-menopausal women with insomnia. Sleep Med. 2011 Jan;12(1):65-9. PMID: 21147026.
- Stores G. Clinical diagnosis and misdiagnosis of sleep disorders. J Neurol Neurosurg Psychiatry. 2007 Dec;78(12):1293-7. PMID: 18024690.
- Espie CA, Kyle SD, Hames P, et al. The daytime impact of DSM-5 insomnia disorder: comparative analysis of insomnia subtypes from the Great British Sleep Survey. J Clin Psychiatry. 2012 Dec;73(12):e1478-84. PMID: 23290331.
- Morin CM, Vallieres A, Guay B, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. PMID: 19454639.
- National Institutes of Health. National Institutes of Health State of the Science Conference Statement on Manifestations and Management of Chronic Insomnia in Adults, June 13–15, 2005. Sleep. 2005 Sep;28(9):1049-57. PMID: 16268373.
- Baillargeon L, Landreville P, Verreault R, et al. Discontinuation of benzodiazepines among older insomniac adults treated with cognitive-behavioural therapy combined with gradual tapering: a randomized trial.CMAJ. 2003 Nov 11;169(10):1015-20. PMID: 14609970.
- Espie CA. "Stepped care": a health technology solution for delivering cognitive behavioral therapy as a first line insomnia treatment. Sleep. 2009 Dec;32(12):1549-58. PMID: 20041590.