Safety profile and clinical course of patients with insomnia administered suvorexant by initial treatment status in a post-marketing survey

ABSTRACT

Objectives: Suvorexant is a dual orexin receptor antagonist used for treating insomnia. The authors elucidated the safety profiles and clinical course of insomnia therapy with suvorexant under different initial treatment status seen in daily routine practice.

Methods: Subgroup analysis of a post-marketing survey (PMS; 2015–2017) divided patients based on their initial treatment status with suvorexant into ‘hypnotic-naïve (Group N)’, ‘switching from a prior sleep medication (Group S),’ ‘add-on therapy (Group A),’ and ‘others (Group O).’

Results: Among 3248 patients analyzed in the PMS, the number of patients in Groups N, S, A, and O was 1946 (59.9%), 703 (21.6%), 536 (16.5%), and 63 (1.9%), respectively. The incidence of insomnia-related adverse drug reactions (ADRs) in Group S (5.3%) tended to be higher than that in Groups N (0.46%) and A (1.5%). Discontinuation rate due to an inadequate effect at 6 months in Group S (14.9%) tended to be higher than that in Groups N (9.6%) and A (10.4%).

Conclusion: The results suggest that initiating suvorexant treatment after switching from other insomnia medication must require careful monitoring of insomnia-related ADRs, which might be due to abrupt discontinuation of the prior insomnia medication use.

KEYWORDS:

• Add-on therapy
• drug-naïve
• medication switch
• insomnia
• post-marketing survey
• suvorexant

Acknowledgments

The authors would like to thank the study investigators for providing us with the data. The authors are also indebted to Kathryn M. Connor and W. Joseph Herring (Merck & Co., Inc., Kenilworth, NJ, USA) and Shigeru Tokita and Shoki Okuda (MSD K.K., Tokyo, Japan) for their review and editorial input into this manuscript. The authors would like to thank Editage (www.editage.jp) for English language editing.

Author contributions

H Sano contributed to data analysis, data interpretation, drafting, and editing of the manuscript. Y Asai, M Miyazaki, M Iwakura, Y Maeda and M Hara contributed to the study design, study conduct, data collection, data analysis, data interpretation, and critical revisions in the manuscript for important intellectual content. All authors provided the final approval of the manuscript for submission.

Declaration of interest

All authors are employees of MSD K.K., Tokyo, Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was sponsored by MSD K.K., Tokyo, Japan.