Amir Qaseem, MD, PhD, MHA; Devan Kansagara, MD, MCR; Mary Ann Forciea, MD; Molly Cooke, MD; Thomas D. Denberg, MD, PhD; for the Clinical Guidelines Committee of the American College of Physicians *
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Dr. Barry reports grants, personal fees, and nonfinancial support from the Informed Medical Decisions Foundation and Healthwise outside the submitted work. Dr. Manaker reports personal fees from work as a grand rounds speaker, lecturer, consultant, and expert witness on documentation, coding, billing, and reimbursement to hospitals, physicians, departments, practice groups, professional societies, insurers, and attorneys; personal fees from work as an expert witness in workers' compensation and medical negligence matters; dividend income from stock held by his spouse in Pfizer and Johnson & Johnson; and meal and travel expenses for serving on the Centers for Medicare & Medicaid Services Hospital Outpatient Panel, the American Medical Association/Specialty Society Relative Value Unit Update Committee, the Board of Regents of the American College of Chest Physicians (ACCP), and the Board of Directors of ACCP Enterprises. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2175. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed. Drs. Boyd and Wilt participated in the discussion for this guideline but were each recused from voting on the recommendations because of an active indirect conflict. A record of disclosures and management of conflicts of interest is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed at www.acponline.org/about-acp/who-we-are/leadership/committees-boards-councils/clinical-guidelines-committee/disclosure-of-interests-for-clinical-guidelines-committee.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Kansagara: Portland VA Medical Center, 3805 NE 34th Avenue, Portland, OR 97212.
Dr. Forciea: Penn Health System, 3615 Chestnut Street, Philadelphia, PA 19104.
Dr. Cooke: University of California, San Francisco, 550 16th Street, San Francisco, CA 94158.
Dr. Denberg: Carilion Clinic, PO Box 13727, Roanoke, VA 24036.
Author Contributions: Conception and design: A. Qaseem, D. Kansagara, M. Cooke, R. McLean.
Analysis and interpretation of the data: A. Qaseem, D. Kansagara, M.A. Forciea, M. Cooke, M.J. Barry, R.P. Harris, S. Manaker, R. McLean, S. Vijan.
Drafting of the article: A. Qaseem, D. Kansagara, M. Cooke, T. Denberg, R.D. Chow.
Critical revision of the article for important intellectual content: A. Qaseem, D. Kansagara, M.A. Forciea, M. Cooke, T. Denberg, M.J. Barry, R.D. Chow, R.P. Harris, S. Manaker, R. McLean, S. Vijan.
Final approval of the article: A. Qaseem, D. Kansagara, M.A. Forciea, M. Cooke, T. Denberg, M.J. Barry, R.D. Chow, N. Fitterman, R.P. Harris, L.L. Humphrey, S. Manaker, R. McLean, S. Vijan.
Statistical expertise: A. Qaseem.
Obtaining of funding: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem.
Collection and assembly of data: A. Qaseem, M. Cooke.
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.
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.
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)
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)
Appendix Table 1. Psychological Interventions for Insomnia Disorder*
Table. The American College of Physicians' Guideline Grading System*
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*
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.
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Karen J. Klingman PhD RN, Michael Perlis PhD, Carla Jungquist PhD RN, Donn Posner PhD CBSM
Associate Professor - College of Nursing - Upstate Medical University State University of New York; Director of the Behavioral Sleep Medicine Program- Associate Professor Department of Psychiatry - As
June 10, 2016
Conflict of Interest:
Dr. Perlis is author of a CBT-I manual and is instructor for two not-for-profit courses on CBT-I<br/>Dr. Posner is author of several CBT-I educational products
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 NursingUpstate Medical University, State University of New YorkSyracuse, NYMichael Perlis, PhDDirector of the Behavioral Sleep Medicine ProgramAssociate Professor, Department of PsychiatryAssociate Professor, School of NursingUniversity of PennsylvaniaPhiladelphia, PA, USACarla Jungquist, PhD, RNAssistant Professor, School of NursingUniversity at Buffalo, The State University of New YorkBuffalo, NYDonn Posner, PhD, CBSMAdjunct Clinical Associate ProfessorStanford University School of MedicinePsychiatry and Behavioral SciencesPalo Alto Veterans Institute for Research Veterans Affairs Palo Alto Health Care SystemPalo Alto, California† The SDS-CL-25 is in development and may be found on line athttps://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.html1. 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/M15-21752. 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.159.1.53. Morin CM, Benca R. Chronic insomnia. Lancet. 2012;379:1129-41. [PMID: 22265700] doi: 10.1016/S0140-6736(11)60750-24. 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.44106. 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]
Thomas E. Finucane, MD
Johns Hopkins Bayview Medical Center
July 25, 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.
Devan Kansagara, MD, Timothy J Wilt, MD, Melissa Starkey, PhD, Amir Qaseem, MD, PhD
Portland, VA, Minneapolis VA, ACP
October 20, 2016
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, MCRPortland Evidence-based Synthesis Program and Portland VA Medical CenterTimothy J. Wilt, MD, MPHMinneapolis VA Center for Chronic Disease Outcomes Research and University of Minnesota School of MedicineMelissa Starkey, PhDAmerican College of Physicians; Philadelphia, PennsylvaniaAmir Qaseem, MD, PhDAmerican College of Physicians; Philadelphia, Pennsylvania
Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD, for the Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125–133. doi: 10.7326/M15-2175
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Published: Ann Intern Med. 2016;165(2):125-133.
Published at www.annals.org on 3 May 2016
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