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Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: an American Academy of Sleep Medicine Clinical Practice Guideline Michael J

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Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: an American Academy of Sleep Medicine Clinical Practice Guideline Michael J pii: jc-00382-16 http://dx.doi.org/10.5664/jcsm.6470 SPECIAL ARTICLES Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline Michael J. Sateia, MD1; Daniel J. Buysse, MD2; Andrew D. Krystal, MD, MS3; David N. Neubauer, MD4; Jonathan L. Heald, MA5 1Geisel School of Medicine at Dartmouth, Hanover, NH; 2University of Pittsburgh School of Medicine, Pittsburgh, PA; 3University of California, San Francisco, San Francisco, CA; 4Johns Hopkins University School of Medicine, Baltimore, MD; 5American Academy of Sleep Medicine, Darien, IL Introduction: The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations: The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources. 1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 5. We suggest that clinicians use triazolam as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 6. We suggest that clinicians use temazepam as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 7. We suggest that clinicians use ramelteon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 8. We suggest that clinicians use doxepin as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 9. We suggest that clinicians not use trazodone as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 10. We suggest that clinicians not use tiagabine as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 11. We suggest that clinicians not use diphenhydramine as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 12. We suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 13. We suggest that clinicians not use tryptophan as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 14. We suggest that clinicians not use valerian as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) Keywords: insomnia, treatment, pharmacologic, guideline Citation: Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307–349. 307 Journal of Clinical Sleep Medicine, Vol. 13, No. 2, 2017 MJ Sateia, DJ Buysse, AD Krystal, et al. Clinical Practice Guideline: Insomnia TABLE OF CONTENTS favorable benefit to risk ratio of CBT-I, not all patients with an insomnia disorder can and will derive benefit from this treat- Introduction 308 ment alone. This failure may result from inability to access Background 309 such treatment (due to availability, cost restraints, etc.), inabil- Methodology 312 ity or unwillingness to participate in the therapy, or treatment Clinical Practice Recommendations 315 non-responsiveness. Thus, pharmacotherapy, alone or in com- Orexin receptor agonists bination with CBT-I, must continue to be considered a part of Suvorexant 317 the therapeutic armamentarium, as it currently is for perhaps Benzodiazepine receptor agonists 25% of the population.1 Unfortunately, many individuals use Eszopiclone 318 medications or substances (e.g. over-the-counter sleep aids or Zaleplon 321 alcohol) which are not demonstrated to be effective in manag- Zolpidem 323 ing insomnia and/or have significant potential for harm. For Benzodiazepines the estimated 3.5% to 7% of individuals receiving prescrip- Triazolam 326 tion medication for sleep disturbance,2–4 significant knowledge Temazepam 327 gaps and anxieties about the proper usage of these agents ex- Melatonin agonists ists among the prescribers. Ramelteon 329 This paper includes a systematic review and meta-analyses Heterocyclics which provides the basis of the initial AASM clinical practice Doxepin 331 guideline for pharmacological management of insomnia. The Trazodone 332 aims of the present analysis are: (1) to determine the efficacy Anticonvulsants of individual prescription and non-prescription medications Tiagabine 333 for treatment of insomnia; (2) to assess the efficacy of indi- Over-the-counter preparations vidual medications for specific sleep complaints (i.e. difficulty Diphenhydramine 334 initiating sleep/difficulty maintaining sleep); (3) to evaluate the Melatonin 335 potential for adverse effects of these drugs; (4) to consider the L-tryptophan 337 evidence concerning efficacy and adverse effects in delineat- Valerian 338 ing evidence-based guidelines for the use of pharmacotherapy Literature Reviews 338 in the management of chronic insomnia; and (5) to offer rec- Estazolam 338 ommendations for optimizing quality and uniformity of future Quazepam 339 investigations. Flurazepam 340 This clinical practice guideline is intended to serve as one Oxazepam 341 component in an ongoing assessment of the individual patient Quetiapine 341 with insomnia. As discussed elsewhere,5–7 a comprehensive Gabapentin 341 initial evaluation should include a detailed history of sleep Paroxetine 341 complaints, medical and psychiatric history, and medication/ Trimipramine 342 substance use. These factors, together with patient preferences Discussion and Future Directions 342 and treatment availability, should be used to select specific treatments for specific patients. This clinical practice guide- line is not intended to help clinicians determine which patient INTRODUCTION is appropriate for pharmacotherapy. Rather, it is intended to provide recommendations regarding specific insomnia drugs Aims once the decision has been made to use pharmacotherapy. This This clinical practice guideline was initiated at the request guideline is also not intended to recommend one drug over an- of the Board of Directors of the American Academy of Sleep other. Very few comparative efficacy studies have been con- Medicine (AASM), who also reviewed this document and ducted among these agents. Rather, the guideline provides a provided feedback. No formal clinical practice guidelines for recommendation and evidence base for each individual drug. the pharmacological treatment of insomnia have previously The selection of a particular drug should rest on the evidence been issued by the AASM, despite the fact that this remains, summarized here, as well as additional patient-level factors, by far, the most common approach to therapy, after treatment
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