Lack of Efficacy of Suvorexant in People with Insomnia and Poorly Controlled Type 2 Diabetes

Abstract

Objective/Background

Sleep disturbance is a common and underappreciated feature of diabetes and sleep may contribute to glycemic control in people with type 2 diabetes (T2D). We conducted a 3-month trial to examine the efficacy of suvorexant in improving sleep and health outcomes in people with suboptimally controlled T2D and insomnia.

Participants/Methods

This parallel, double-blind, randomized placebo-controlled trial was conducted using the sequential parallel comparison design (SPCD). Sixty-nine people with poorly controlled T2D (HbA1c ≥ 6.5) were randomized to placebo and/or suvorexant (10–20 mg). The primary outcome was subjective total sleep time (sTST), and secondary outcomes were Insomnia Severity Index (ISI) score and wake time after sleep onset (WASO). Exploratory outcomes included sleep efficiency, hemoglobin A1c (HbA1c), and C-reactive protein (CRP). Exploratory analyses were conducted on relationships between sleep and diabetes outcomes.

Results

There were no significant improvements in sTST (p = 0.27), ISI (p = 0.86), or WASO (p = 0.94) among participants taking suvorexant compared to placebo. There were also no significant changes in any of the exploratory endpoints. Improvements in sleep were associated with improvements in both objective (ie, HbA1c) and subjective (ie, Diabetes Distress Scale) measures of diabetes, as well as reductions in depressive symptoms, independent of treatment assignment.

Conclusion

The study did not find evidence that suvorexant is efficacious for insomnia in people with poorly controlled T2D. The associations of improved sleep with improvements in both diabetes-related metrics and depressive symptoms across groups highlight the importance of identifying and treating sleeping difficulties in this population.

CT Registration #

Nct03818581.

Keywords:

• insomnia
• type 2 diabetes
• sleep disorders
• suvorexant

Data Sharing Statement

No further data will be shared. This study is in compliance with the Declaration of Helsinki.

Acknowledgment

The abstract of this paper was presented at Sleep 2023 as a poster presentation with interim findings. The poster’s abstract was published in Sleep Volume 46, 2023: https://academic.oup.com/sleep/article/46/Supplement_1/A176/7182032?searchresult=1

Disclosure

John Winkelman receives consultation fees from Emalex, Noctrix, and Disc Medicine; personal fees from Idorsia and Disc Medicine; grants from American Regent; and research support from NIDA, the RLS Foundation, and the Baszucki Brain Research Fund. All other authors report no disclosures.

Additional information

Funding

Supported in part by a research grant from Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The opinions expressed inthis paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.