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Review
. 2023 Feb 17;12(4):1629.
doi: 10.3390/jcm12041629.

Long-Term Use of Insomnia Medications: An Appraisal of the Current Clinical and Scientific Evidence

Phyllis C Zee  1 , Suzanne M Bertisch  2 , Charles M Morin  3 , Rafael Pelayo  4 , Nathaniel F Watson  5 , John W Winkelman  6 , Andrew D Krystal  7
Affiliations
Review

Long-Term Use of Insomnia Medications: An Appraisal of the Current Clinical and Scientific Evidence

Phyllis C Zee et al. J Clin Med. .

Abstract

While evidence supports the benefits of medications for the treatment of chronic insomnia, there is ongoing debate regarding their appropriate duration of use. A panel of sleep experts conducted a clinical appraisal regarding the use of insomnia medications, as it relates to the evidence supporting the focus statement, "No insomnia medication should be used on a daily basis for durations longer than 3 weeks at a time". The panelists' assessment was also compared to findings from a national survey of practicing physicians, psychiatrists, and sleep specialists. Survey respondents revealed a wide range of opinions regarding the appropriateness of using the US Food and Drug Administration (FDA)-approved medications for the treatment of insomnia lasting more than 3 weeks. After discussion of the literature, the panel unanimously agreed that some classes of insomnia medications, such as non-benzodiazepines hypnotics, have been shown to be effective and safe for long-term use in the appropriate clinical setting. For eszopiclone, doxepin, ramelteon and the newer class of dual orexin receptor antagonists, the FDA label does not specify that their use should be of a limited duration. Thus, an evaluation of evidence supporting the long-term safety and efficacy of newer non-benzodiazepine hypnotics is timely and should be considered in practice recommendations for the duration of pharmacologic treatment of chronic insomnia.

Keywords: clinical appraisal; insomnia; insomnia medications; long-term use; safety.

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Conflict of interest statement

The authors are solely responsible for the content of this publication and wish to declare the following beyond Idorsia: Phyllis C. Zee has received research grant funding from Vanda Pharmaceuticals (through Northwestern University); served on scientific advisory boards for Eisai, and Jazz; and served as a consultant to Eisai, Jazz, CVS Caremark, Sleep Number, Harmony biosciences and Septerma. She owns equity in Teva Pharmaceuticals. Charles M. Morin as received research grant from Eisai, and Lallemand Health and has served on advisory consultant boards for Eisai, Pear Therapeutics, and Sunovion. He owns equity in BeHealth Solutions and receives royalties from Mapi Research Trust. Suzanne M. Bertisch has served as consultant for ResMed. Rafael Pelayo serves as an advisor to Adaptive Sound Technology, Eisai, SleepQuest, and SleepScore Labs. Nathaniel F. Watson has served as an advisory consultant for Eisai, Jazz Pharmaceuticals, Harmony Biosciences, Takeda, Johnson and Johnson, Itamar, GlaxoSmithKline, Pfizer and Bayer. John W. Winkelman has received research support from Merck. Andrew D. Krystal holds the following research Grants: Janssen Pharmaceuticals, Axsome Pharmaceutics, Neurocrine Biosciences, Reveal Biosensors, The Ray and Dagmar Dolby Family Fund, and the National Institutes of Health. A.D.K. also served as a consultant for the following companies: Adare, Axsome Therapeutics, Big Health, Eisai, Evecxia, Ferring Pharmaceuticals, Galderma, Harmony Biosciences, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage, Takeda, Angelini.

Figures

Figure 1
Figure 1
Voting results for the statement “No insomnia medication should be used on a daily basis for durations longer than 3 weeks at a time”. Survey participants n = 508, seven expert panelists voted before the literature search on the statement and post-presentation of the literature.
Figure 2
Figure 2
Mean Voting level for the statement “No insomnia medication should be used on a daily basis for durations longer than 3 weeks at a time”. Survey participants n = 508, 7 expert panelists voted before the literature search on the statement and post-presenting of the literature. 1 = strongly agree, 2 = mostly agree but with minor reservations, 3 = slightly agree but with major reservations, 4 = slightly disagree, due to minor reservations, 5 = mostly disagree, due to major reservations, 6 = strongly disagree.
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Grants and funding

Publication of this open-access online article is the result of a survey assessment conducted by the publisher. The Insomnia Clinical Appraisal December 2021 project was initiated and funded by Idorsia Pharmaceuticals Ltd. (Idorsia). Management of the meeting and survey, and medical writing and editorial support was funded by Idorsia and was provided by LAS Communications, Inc. Idorsia identified the chairperson and faculty members and was consulted in the development and review of the practice statements. All seven authors were members of the Alliance for Sleep funded by Idorsia. Idorsia conducted a medical review of the final draft publication. Authors received financial reimbursement by Idorsia for time spent on the literature review and analysis but received no compensation towards the development and writing of this manuscript.