Clinical Guidelines19 July 2016

Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians

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    Abstract

    Description:

    The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of chronic insomnia disorder in adults.

    Methods:

    This guideline is based on a systematic review of randomized, controlled trials published in English from 2004 through September 2015. Evaluated outcomes included global outcomes assessed by questionnaires, patient-reported sleep outcomes, and harms. The target audience for this guideline includes all clinicians, and the target patient population includes adults with chronic insomnia disorder. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

    Recommendation 1:

    ACP recommends that all adult patients receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder. (Grade: strong recommendation, moderate-quality evidence)

    Recommendation 2:

    ACP recommends that clinicians use a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (Grade: weak recommendation, low-quality evidence)

    Insomnia is a major health care problem in the United States. It is defined as dissatisfaction with sleep quantity or quality and is associated with difficulty initiating or maintaining sleep and early-morning waking with inability to return to sleep (1). Approximately 6% to 10% of adults have insomnia that meets diagnostic criteria (1–4). Insomnia is more common in women and older adults (5, 6) and can occur independently or be caused by another disease. People with the disorder often experience fatigue, poor cognitive function, mood disturbance, and distress or interference with personal functioning (2, 4). An estimated $30 billion to $107 billion is spent on insomnia in the United States each year (7). Insomnia also takes a toll on the economy in terms of loss of workplace productivity, estimated at $63.2 billion in the United States in 2009 (8).

    Chronic insomnia, also referred to as “chronic insomnia disorder” in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), is diagnosed according to the DSM-5 (9) and the International Classification of Sleep Disorders (10), which have similar criteria for making the diagnosis. These criteria specify that symptoms must cause clinically significant functional distress or impairment; be present for at least 3 nights per week for at least 3 months; and not be linked to other sleep, medical, or mental disorders (1). Symptoms of insomnia differ between older adults and the younger population. Older adults are more likely to report problems with waking after sleep onset (difficulty maintaining sleep) than they are to report problems with sleep onset latency (time to fall asleep).

    The goal of treatment for insomnia is to improve sleep and alleviate distress or dysfunction caused by the disorder. Insomnia can be managed with psychological therapy, pharmacologic therapy, or a combination of both. Psychological therapy options include cognitive behavioral therapy for insomnia (CBT-I); multicomponent behavioral therapy or brief behavioral therapy (BBT) for insomnia; and other interventions, such as stimulus control, relaxation strategies, and sleep restriction (see Appendix Table 1 for a description of these interventions). Cognitive behavioral therapy for insomnia is multimodal cognitive behavioral therapy targeted specifically to insomnia. It consists of a combination of cognitive therapy, behavioral interventions (such as sleep restriction and stimulus control), and educational interventions (such as sleep hygiene). Various delivery methods are available, including in-person individual or group therapy, telephone- or Web-based modules, and self-help books. Trained clinicians or mental health professionals can administer CBT-I.

    Appendix Table 1. Psychological Interventions for Insomnia Disorder*

    Pharmacologic therapy in the United States includes drugs approved by the U.S. Food and Drug Administration (FDA) for insomnia treatment, including benzodiazepines (triazolam, estazolam, temazepam, flurazepam, and quazepam); nonbenzodiazepine hypnotics (zaleplon, zolpidem, and eszopiclone); the recently approved orexin receptor antagonist suvorexant; the melatonin receptor agonist ramelteon; the antidepressant doxepin; off-label use of drugs, such as other antidepressants, antihistamines, and antipsychotics; and melatonin.

    Complementary and alternative approaches, including acupuncture and Chinese herbal medicine, have also been used to treat insomnia.

    Guideline Focus and Target Population

    The purpose of this American College of Physicians (ACP) guideline is to present recommendations based on the evidence on the efficacy, comparative effectiveness, and safety of treatments for chronic insomnia disorder. The target audience for this guideline includes all clinicians, and the target patient population includes all adults with chronic insomnia disorder. These recommendations are based on 2 background evidence review papers (11, 12) and an evidence review sponsored by the Agency for Healthcare Research and Quality (AHRQ) (13).

    Methods
    Systematic Review of the Evidence

    The evidence review was conducted by the AHRQ's Minnesota Evidence-based Practice Center. The summary of methods for the evidence review is provided in the Appendix, and additional details are included in the accompanying background evidence review papers (11, 12) and the full evidence report (13). Reviewers searched several databases for randomized, controlled trials (RCTs) published in English from 2004 through September 2015. The study population included adults (aged ≥18 years) with chronic insomnia disorder (insomnia definitions that match diagnostic criteria for insomnia disorder).

    The systematic evidence review evaluated psychological therapies, including CBT-I, multicomponent behavioral therapy or BBT for insomnia, stimulus control, relaxation strategies, and sleep restriction; pharmacologic therapies, including doxepin, triazolam, estazolam, temazepam, flurazepam, quazepam, zaleplon, zolpidem, eszopiclone, ramelteon, suvorexant, off-label use of drugs (such as antidepressants and antipsychotics), and melatonin; and complementary and alternative approaches, including acupuncture and Chinese herbal medicine. Evaluated outcomes included global outcomes assessed by questionnaires (such as treatment response), patient-reported and intermediate sleep outcomes, and harms.

    Grading the Evidence and Developing Recommendations

    This guideline was developed by the ACP Clinical Guidelines Committee according to the ACP guideline development process, details of which can be found in the ACP methods paper (14). The Clinical Guidelines Committee used the evidence tables in the accompanying systematic review and full report (11, 12) when reporting the evidence and graded the recommendations by using the ACP system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach (Table).

    Table. The American College of Physicians' Guideline Grading System*
    Peer Review

    The AHRQ evidence review was sent to invited peer reviewers and posted on the AHRQ Web site for public comments. The guideline was peer reviewed through the journal and was posted online for comments from ACP Regents and Governors, who represent physician members at the national level.

    Benefits of Treatments for Chronic Insomnia Disorder

    The efficacy, safety, and comparative effectiveness of psychological and pharmacologic treatments for chronic insomnia disorder are summarized in Appendix Tables 2, 3, 4 and 5 and in the accompanying evidence reviews (11, 12). Evidence is described for the general adult population as well as for older adults (aged >55 years).

    Appendix Table 2. Efficacy and Safety of Psychological Treatments for Chronic Insomnia Disorder in All Adults*
    Appendix Table 3. Efficacy and Safety of Psychological Treatments for Chronic Insomnia Disorder in Older Adults*
    Appendix Table 4. Efficacy and Safety of Pharmacologic Treatments for Insomnia Disorder in All Adults*
    Appendix Table 5. Efficacy and Safety of Pharmacologic Treatments for Insomnia Disorder in Older Adults*
    Psychological Treatment

    Evidence for most psychological therapies was limited, and there was insufficient evidence to determine the comparative effectiveness of different psychological treatments for chronic insomnia disorder in the general population or in older adults.

    General Population

    Moderate-quality evidence showed that CBT-I improved remission, treatment response, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality in the general population (15–34). Improvements were seen across the various methods of CBT-I delivery, including in-person individual therapy (18, 24, 33, 35, 36), in-person group therapy (19, 20, 31), telephone-based modules (21), Web-based modules (17, 22, 23, 25), and self-help books (26, 29, 37); however, evidence was insufficient to determine the superiority of one method over another.

    Low-quality evidence showed that stimulus control improved sleep onset latency and total sleep time in the general population (38, 39).

    Older Population

    For older adults, moderate-quality evidence showed that CBT-I improved Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores compared with controls, and low- to moderate-quality evidence showed that CBT-I improved sleep onset latency, wake after sleep onset, and sleep efficiency (40–46).

    Low- to moderate-quality evidence showed that multicomponent behavioral therapy or BBT improved sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality in older adults (47–50). Low-quality evidence showed that stimulus control improved total sleep time in older adults (51, 52).

    Pharmacologic Treatment

    Evidence was insufficient to determine the benefits of pharmacologic therapy with benzodiazepines in the general population or in older adults. Few trials met the inclusion criteria for the evidence review, largely because many assessed short durations of treatment.

    General Population

    Low-quality evidence showed that eszopiclone improved remission, and low- to moderate-quality evidence showed that it improved sleep onset latency, total sleep time, and wake after sleep onset compared with placebo in the general population (53–55). Zaleplon did not improve total sleep time in the general population (low-quality evidence) (56, 57). Moderate-quality evidence showed that zolpidem improved sleep onset latency and total sleep time in the general population (56–61). Zolpidem taken “as needed” improved Clinical Global Impression scores (62) (low-quality evidence), sleep onset latency, and total sleep time (moderate-quality evidence) in the general population (62–64). Zolpidem extended-release improved Clinical Global Impression scores, sleep onset latency, total sleep time, and wake after sleep onset in the general population (low-quality evidence) (65). Low-quality evidence showed that sublingual zolpidem reduced sleep onset latency after middle-of-the-night waking (66). Moderate-quality evidence showed that suvorexant increased treatment response and improved sleep onset latency, total sleep time, and wake after sleep onset compared with placebo in mixed general populations (67). Doxepin improved total sleep time and wake after sleep onset in the general population (low-quality evidence) (68).

    Older Population

    In older adults, low-quality evidence showed that eszopiclone improved remission, total sleep time, and wake after sleep onset (69). Low-quality evidence showed that zolpidem reduced sleep onset latency in older adults (70). Suvorexant increased treatment response and improved sleep onset latency, total sleep time, and wake after sleep onset compared with placebo in mixed older populations (moderate-quality evidence) (67). Low-quality evidence showed that ramelteon reduced sleep onset latency in older adults (71). Doxepin improved mean ISI scores, sleep onset latency, total sleep time, and wake after sleep onset in older adults (low- to moderate-quality evidence) (72, 73).

    Complementary and Alternative Treatments

    There was insufficient evidence to determine the safety or efficacy of complementary and alternative treatments for insomnia disorder in the general population or in older adults (13).

    Comparative Effectiveness of Different Types of Interventions

    Overall, evidence was insufficient to determine the comparative efficacy of pharmacologic treatments for insomnia disorder in the general population or in older adults.

    Harms of Treatments for Chronic Insomnia Disorder

    A full summary of the evidence supporting the harms of treatments for chronic insomnia disorder is provided in Appendix Tables 2, 3, 4 and 5 and the accompanying evidence reviews (11, 12).

    Psychological Treatment

    Specific adverse effects were not reported for psychological interventions, and withdrawals were not reported for treatment versus control groups. Therefore, evidence was insufficient to determine the harms of psychological interventions. However, due to the noninvasive nature of CBT-I, adverse effects are likely to be mild.

    Pharmacologic Treatment

    Harms were insufficiently reported in many of the included RCTs, which most often provided data only on study withdrawals. In addition to evidence from the systematic review on study withdrawals and adverse effects, specific adverse effects associated with the various pharmacologic treatments are summarized in Appendix Tables 4 and 5.

    Data from observational studies suggest that serious adverse effects, such as dementia and fractures, may be associated with hypnotic drugs (74, 75). Product labels from the FDA warn patients about cognitive and behavioral changes, such as possible driving impairment and motor vehicle accidents, as well as other adverse effects. The FDA also recommends lower doses of benzodiazepine and nonbenzodiazepine hypnotics in women and in older or debilitated adults. In addition, the FDA recommends short-term use of these drugs, although many patients may continue their use for extended periods.

    Comparative Safety of Pharmacologic Treatments

    Evidence was generally insufficient to determine the comparative safety of various pharmacologic treatments.

    The Figure summarizes the recommendations and clinical considerations.

    Figure. Summary of the American College of Physicians guideline on management of chronic insomnia disorder in adults.

    BBT = brief behavioral therapy; CBT-I = cognitive behavioral therapy for insomnia; CGI = Clinical Global Impression Scale; FDA = U.S. Food and Drug Administration; ISI = Insomnia Severity Index; PSQI = Pittsburgh Sleep Quality Index; RCT = randomized, controlled trial; SOL = sleep onset latency; TST = total sleep time; WASO = wake after sleep onset.

    Recommendations

    Recommendation 1: ACP recommends that all adult patients receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder. (Grade: strong recommendation, moderate-quality evidence)

    Cognitive behavioral therapy for insomnia consists of a combination of treatments that include cognitive therapy around sleep, behavioral interventions (such as sleep restriction and stimulus control), and education (such as sleep hygiene). It can be performed in primary care (18, 19). There are various delivery methods for CBT-I, such as individual or group therapy, telephone- or Web-based modules, or self-help books. Most studies focused on in-person CBT-I; however, the data suggest that other delivery methods are also effective.

    Cognitive behavioral therapy for insomnia should be considered first-line treatment for adults with chronic insomnia disorder. Although the current evidence is insufficient to show the harms associated with behavioral interventions, any such harms are likely to be mild. Moderate-quality evidence showed that CBT-I improved global outcomes in the general population, including increased remission and treatment response and reduced ISI and PSQI scores compared with controls. Moderate-quality evidence showed that CBT-I also improved sleep outcomes in the general population, including reduced sleep onset latency and wake after sleep onset and improved sleep efficiency and sleep quality. Low- to moderate-quality evidence showed that CBT-I also improved global and sleep outcomes in older adults, including improved PSQI and ISI scores, reduced sleep onset latency, and improved sleep efficiency. Moderate-quality evidence showed that CBT-I reduced wake after sleep onset in older adults.

    Recommendation 2: ACP recommends that clinicians use a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (Grade: weak recommendation, low-quality evidence)

    Benefits of pharmacologic treatment include improved sleep outcomes, such as sleep onset latency and total sleep time, and in some cases improved global outcomes in the general population and in older adults. Most studies have examined newer medications, whereas commonly used older and generic medications, such as diphenhydramine and trazodone, have not been studied. Low-quality evidence showed that both eszopiclone and zolpidem improved global outcomes in the general population, and low- to moderate-quality evidence showed that eszopiclone, zolpidem, and doxepin improved sleep outcomes, such as sleep onset latency, total sleep time, and wake after sleep onset. Moderate-quality evidence showed that suvorexant, an orexin antagonist recently approved by the FDA, improved treatment response and sleep outcomes in mixed general and adult populations. Low-quality evidence showed no statistically significant difference between ramelteon and placebo for sleep outcomes in the general population.

    In older adults, low-quality evidence showed that eszopiclone improved global and sleep outcomes and both zolpidem and ramelteon decreased sleep onset latency. Moderate-quality evidence showed that doxepin improved ISI scores, and low- to moderate-quality evidence showed that it improved sleep outcomes.

    Evidence was insufficient for melatonin in the general population and in older adults. Benzodiazepines, although widely used, were not addressed in this guideline because few studies met the inclusion criteria of the systematic review (insufficient evidence).

    Evidence on harms was limited from RCTs that met the inclusion criteria for the review, which mostly reported on study withdrawals. However, observational studies have shown that hypnotic drugs may be associated with infrequent but serious adverse effects, such as dementia, serious injury, and fractures (74, 75, 76, 77). In addition, FDA labels warn of daytime impairment, “sleep driving,” behavioral abnormalities, and worsening depression. The FDA suggests dosages lower than those used in many of the included studies, especially for older adults.

    Evidence is insufficient to evaluate the balance of the benefits and harms of long-term use of pharmacologic treatments in adults with chronic insomnia disorder. The FDA has approved pharmacologic therapy for short-term use (4 to 5 weeks), and patients should not continue using the drugs for extended periods. The FDA also recommends that patients with insomnia that does not remit within 7 to 10 days of treatment should be further evaluated.

    There was insufficient evidence overall on the comparative effectiveness and safety of the various pharmacologic treatments. See Appendix Tables 4 and 5 for a summary of efficacy, adverse events, and costs for pharmacologic treatments and the Figure for clinical considerations.

    Areas With Insufficient Evidence

    For nonpharmacologic therapy, evidence was insufficient to determine the effect of multicomponent behavioral interventions or BBT, sleep restriction, stimulus control, or relaxation therapy on global outcomes in the general population or in older adults with chronic insomnia disorder. There was also insufficient evidence to determine the effect of sleep restriction or relaxation therapy on sleep outcomes in these populations.

    For pharmacologic therapy, there was insufficient evidence on the effectiveness of benzodiazepine hypnotics (temazepam, triazolam, flurazepam, or quazepam), melatonin, or trazodone on global or sleep outcomes in the general population or in older adults with chronic insomnia disorder. Evidence was also insufficient for the effectiveness of complementary and alternative treatments.

    There was insufficient evidence to determine the comparative safety or efficacy of pharmacologic or psychological treatments for insomnia disorder in the general population or in older adults. Trials comparing pharmacologic and nonpharmacologic therapies are lacking and would be useful. Evidence was insufficient for pharmacologic therapy or the choice of agent to treat patients with sleep maintenance insomnia if CBT-I alone was unsuccessful. There was insufficient evidence for the balance of the benefits and harms of long-term use of pharmacologic treatments in adults with chronic insomnia disorder.

    High-Value Care

    Cognitive behavioral therapy for insomnia is an effective therapy for chronic insomnia disorder and can be performed and prescribed in the primary care setting. Evidence showed that CBT-I was effective in treating the general population of adults as well as older adults with chronic insomnia disorder. There is insufficient evidence to directly compare CBT-I and pharmacologic treatment. However, because CBT-I is noninvasive, it is likely to have fewer harms, whereas pharmacologic therapy can be associated with serious adverse events. Thus, CBT-I provides better overall value than pharmacologic treatment. As indicated on FDA labeling, pharmacologic treatments for insomnia are intended for short-term use, and patients should be discouraged from using these drugs for extended periods. Because few studies evaluated the use of the medications for more than 4 weeks, long-term adverse effects are unknown.

    Appendix: Detailed Methods

    The evidence review was conducted by the Minnesota Evidence-based Practice Center to address the following key questions:

    1. What are the efficacy and comparative effectiveness of treatments for insomnia disorder in adults?

    a. What are the efficacy and comparative effectiveness of treatments for insomnia disorder in specific subgroups of adults?

    b. 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?

    c. What are the long-term efficacy and comparative effectiveness of treatments for insomnia disorder in adults?

    2. What are the harms of treatments for insomnia disorder in adults?

    a. What are the harms of treatments for insomnia disorder in specific subgroups of adults?

    b. What are the harms of combined treatments (e.g., cognitive behavioral therapy and drug therapy) for insomnia disorder in adults?

    c. What are the long-term harms of treatments for insomnia disorder in adults?

    Search Strategy

    The systematic literature search included English-language RCTs published from 2004 through September 2015 (nonpharmacologic interventions), identified using MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and PsycINFO bibliographic databases as well as hand-searches of references of relevant studies. Studies were limited to RCTs of at least 4 weeks' duration that enrolled participants with insomnia disorder and reported global or sleep outcomes. Studies focused on patient-reported outcomes rather than sleep measures obtained by actigraphy and polysomnography. Large observational studies on pharmacologic hypnotics in adults with insomnia were included for consideration of harms data.

    Quality Assessment

    The quality of studies was assessed using the Cochrane Risk of Bias tool and the AHRQ handbook (78, 79), and the quality of systematic reviews was assessed using the AMSTAR (A Measurement Tool to Assess Systematic Reviews) criteria (80). Additional information, including inclusion and exclusion criteria, is in the full evidence report (13) and the accompanying articles (11, 12). This guideline rates the evidence and recommendations by using the ACP guideline grading system (Table).

    Population Studied

    Studies were limited to adults older than 18 years with chronic insomnia disorder (that is, insomnia definitions that matched diagnostic criteria for insomnia disorder). “Older adults” were those older than 55 years. Patients who use alcohol to treat their insomnia disorder and those who misuse or abuse alcohol were outside the scope of this guideline.

    Interventions Evaluated

    Psychological therapy included CBT-I, multicomponent behavioral therapy or BBT for insomnia, stimulus control, relaxation strategies, and sleep restriction. Pharmacologic therapy included doxepin, triazolam, estazolam, temazepam, flurazepam, quazepam, zaleplon, zolpidem, eszopiclone, ramelteon, and suvorexant; off-label use of drugs, such as antidepressants and antipsychotics; and melatonin. Complementary and alternative approaches included acupuncture and Chinese herbal medicine.

    Comparators

    Psychological interventions were compared with usual care, wait-list controls (patients who have not yet received the intervention but are on a wait list to receive it), or other insomnia treatments. Efficacy or effectiveness of pharmacologic interventions and complementary and alternative approaches were compared with those of placebo or another agent in the same or another drug class.

    Outcomes

    The goal of insomnia treatment is meaningful improvement in sleep and associated distress and/or dysfunction. Outcomes evaluated included 1) global outcomes, which measure improvements in sleep and related daytime dysfunction or distress and were assessed by the ISI and the PSQI; 2) sleep outcomes, which can be objective or patient-reported from sleep diaries and include sleep onset latency, wake after sleep onset, total sleep time, the intermediate sleep measures of sleep efficiency (total sleep time divided by the total time in bed) and sleep quality, function, mood, and quality of life; and 3) harms of treatment, such as adverse effects and study withdrawals.

    Target Audience

    The target audience for this guideline includes all clinicians, patients, health system leaders, and policymakers.

    Target Patient Population

    The target patient population includes all adults with chronic insomnia disorder.

    Limitations

    Sample sizes were small in most of the included RCTs, which were also of short duration. Minimally important differences were often not established or used in the studies. A large placebo response was observed for pharmacologic treatments.

    Grading the Evidence and Developing Recommendations

    This guideline was developed by the ACP Clinical Guidelines Committee according to the ACP guideline development process, details of which can be found in the ACP methods paper (14). The Clinical Guidelines Committee used the evidence tables in the accompanying systematic review and full report (11–13) when reporting the evidence and graded the recommendations by using the ACP guideline grading system (Table).

    Peer Review

    The AHRQ evidence review was sent to invited peer reviewers and posted on the AHRQ Web site for public comments. The guideline underwent a peer review process through the journal and was posted online for comments from ACP Regents and Governors, who represent physician members at the national level.

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    Comments

    Devan Kansagara, MD, Timothy J Wilt, MD, Melissa Starkey, PhD, Amir Qaseem, MD, PhD20 October 2016
    Author's Response
    IN RESPONSE: We share Dr. Finucane’s concern about the over use of pharmacologic therapy, and it applies to many disease conditions beyond insomnia. Therefore, it is incredibly important that the benefits of pharmacologic therapy for insomnia are compared with the harms and costs before initiating pharmacologic therapy. We recommended cognitive behavioral therapy – insomnia (CBT-I) as first line treatment, rather than pharmacologic therapy. We also advocated for a shared decision making approach with the patient and caution when considering pharmacologic options. In addition, our guideline contains a high value care section promoting CBT-I over medications.

    We agree that focusing on patient-centered outcomes is important. We did not consider evidence on laboratory-measured sleep outcomes, rather the evidence review collected data on global outcomes when available, which included questionnaires that addressed problems and worry about sleep and accompanying distress or dysfunction. We also acknowledge the limitations of these studies and the evidence. However, the sleep outcomes reported in the evidence review and guideline were collected from patient diaries, and while patients may estimate numbers such as total sleep time or wake after sleep onset incorrectly, they are still patient-centered.

    Devan Kansagara, MD, MCR
    Portland Evidence-based Synthesis Program and Portland VA Medical Center

    Timothy J. Wilt, MD, MPH
    Minneapolis VA Center for Chronic Disease Outcomes Research and University of Minnesota School of Medicine

    Melissa Starkey, PhD
    American College of Physicians; Philadelphia, Pennsylvania

    Amir Qaseem, MD, PhD
    American College of Physicians; Philadelphia, Pennsylvania
    Thomas E. Finucane, MD26 July 2016
    Insomnia: Dissatisfaction, disorder, drug target?
    In their Guideline, Qaseem and colleagues define insomnia as “dissatisfaction with sleep quantity or quality” and note that $30 billion to $107 billion is spent annually on this dissatisfaction. Dissatisfaction and sleep disturbance are not closely related. (1) A 1976 study of 122 patients with chronic insomnia compared sleep laboratory findings and self-reports the morning after and found that “(m)ost subjects consistently underestimated the amount of time they slept and overestimated the time it took them to get to sleep in comparison with laboratory data … fewer than 1 patient in 5 with a complaint of very short sleep or very long sleep latency will have the complaint confirmed in a laboratory sleep recording.” (These authors express alarm about the spending levels for prescription hypnotics, an estimated $170 million in 1970.) (2)

    Since we have precious little understanding of what sleep is or how it works, a true measure of drug benefit is to ask whether the patient performs better or is more wide awake the day after a drug-induced sleep. In the elderly precisely the opposite effect was shown by Glass and colleagues. Adverse cognitive and psychomotor events and reports of daytime fatigue were significantly and substantially more common ’”in people using any sedative compared with placebo.” (3) Wilt and colleagues’s Evidence Report cites concerns about “increased risk for dementia, fractures, major injury … cognitive and behavioral changes, including driving impairment.” (4)

    Recent promotion of insomnia as a serious, drug-treatable disease, much of it by the pharmaceutical industry, has been vigorous. As defined in the Guideline the main goal of drug treatment for this disorder is to render patients unconscious for a subjective interval that satisfies them (thus relieving the insomnia). For some reason sleep-study measures, very weakly related to the disorder, are used as intermediate endpoints. (Why not just ask the patient if he or she is satisfied?) Spending many billions of dollars and engendering these harms to relieve this particular dissatisfaction does not seem to be Choosing Wisely.

    (1) Qaseem A, Kansagara D, Forciea MA et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.

    (2) Carskadon MA, Dement WC, Mitler MM et al. Self-reports versus sleep laboratory findings in 122 drug-free subjects with complaints of chronic insomnia. Am J Psychiatry. 1976 Dec;133(12):1382-8. PMID: 185919.

    (3) Glass J, Lanctôt KL, Herrmann N et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. Epub 2005 Nov 11. PMID:16284208 PMCID: PMC1285093.

    (4) Wilt TJ, MacDonald R, Brasure M et al. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):103-12. doi: 10.7326/M15-1781. Epub 2016 May 3.
    Karen J. Klingman PhD RN, Michael Perlis PhD, Carla Jungquist PhD RN, Donn Posner PhD CBSM10 June 2016
    Implementing the ACP CBT-I recommendation: outcomes, assessment, referral, and training
    TO THE EDITOR:

    The ACP’s recommendation that CBT-I be the first line indication for all adults suffering from chronic insomnia is to be applauded (1). The guideline highlights the paradigmatic shift that has occurred with the DSM-5 reclassification of insomnia as a disorder in its own right. Further, the recommendation highlights the contrast between the use of hypnotics and CBT-I. While producing comparable acute outcomes (2), hypnotics are not ideal for true maintenance therapy and they do not produce durable gains following treatment discontinuation. In contrast, CBT-I is a short term intervention (usually 4-12 weeks) where up to 70% of subjects exhibit a treatment response and nearly 40% recover average or good sleep (3). More than this, when CBT-I is applied to patients with related comorbities (e.g., depression, chronic pain, etc.) there is evidence that targeted treatment for insomnia influences the course of the related comorbities. The best data of this type show that CBT-I, when applied concurrently with antidepressants, doubles responder and remitter rates (4) and reduces suicidal ideation by up to 65% (5). Given these considerations, the question is no longer “what treatment should be the first line therapy for chronic insomnia”, the question is “how can the recommendations of the ACP be implemented? Within the context of primary care, the first step is assessment and the second step is referral. Assessment could be as simple as “how are you sleeping”. Those that endorse sleep problems could be further assessed using a short general screening questionnaire (two presently exist; the GSAQ (6) or the SDS-CL-25†). Those that endorse trouble falling and/or staying asleep may be further evaluated for their insomnia using the ISI (7). Once these data are obtained, the primary care clinician can utilize an algorithm for questionnaire cutoff scores to make treatment/referral decisions. Treatment may be provided in the primary care setting or by referral to specialists. In either case, treatment should be conducted by an experienced CBT-I provider who can dedicate the 4-12 hours (over 4-12 sessions) typically required for evidence based treatment. Specialists may be identified via provider directories††. Finally, primary care clinicians that wish to add to their existing skill set by taking dedicated CE or CME courses in CBT-I, may avail themselves of the training opportunities exist through the VA, the DoD, the SBSM, University of Pennsylvania, University of Massachusetts, and/or Ryerson University.


    Respectfully,

    Karen Klingman, PhD, RN
    Associate Professor, College of Nursing
    Upstate Medical University, State University of New York
    Syracuse, NY

    Michael Perlis, PhD
    Director of the Behavioral Sleep Medicine Program
    Associate Professor, Department of Psychiatry
    Associate Professor, School of Nursing
    University of Pennsylvania
    Philadelphia, PA, USA

    Carla Jungquist, PhD, RN
    Assistant Professor, School of Nursing
    University at Buffalo, The State University of New York
    Buffalo, NY

    Donn Posner, PhD, CBSM
    Adjunct Clinical Associate Professor
    Stanford University School of Medicine
    Psychiatry and Behavioral Sciences
    Palo Alto Veterans Institute for Research
    Veterans Affairs Palo Alto Health Care System
    Palo Alto, California

    † The SDS-CL-25 is in development and may be found on line at
    https://redcap.upstate.edu/surveys/?s=DNT8PL7PNA
    †† CBT-I Provider directories may be found at
    http://www.behavioralsleep.org/index.php/society-of-behavioral-sleep-medicine-providers
    http://www.med.upenn.edu/cbti/provder_directory.html

    1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016; 165:XXX-XXX. doi: 10.7326/M15-2175
    2. Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles D, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002;159:5-11. [PMID: 11772681] doi: 10.1176/appi.ajp.159.1.5
    3. Morin CM, Benca R. Chronic insomnia. Lancet. 2012;379:1129-41. [PMID: 22265700] doi: 10.1016/S0140-6736(11)60750-2
    4. Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008;31:489-95. [PMID: 18457236]
    5. Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R. Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Sleep. 2015;38:259-65. [PMID: 25515115] doi: 10.5665/sleep.4410
    6. Roth T, Zammit G, Kushida C, Doghramji K, Mathias SD, Wong JM, Buysse DJ. A new questionnaire to detect sleep disorders. Sleep Med. 2002;3:99-108. [PMID: 14592227]
    7. Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34:601-8. [PMID: 21532953]

    Disclosures: Dr. Perlis is author of a CBT-I manual and is instructor for two not-for-profit courses on CBT-I
    Dr. Posner is author of several CBT-I educational products