0398 Efficacy of Suvorexant for Insomnia Disorder in Patients with Poorly-Controlled Type 2 Diabetes

Abstract

Abstract Introduction Sleep disturbance is a common and underappreciated feature of diabetes and sleep may contribute to glycemic control in patients with type two diabetes (T2D). We conducted a randomized placebo-controlled 3-month trial to examine the efficacy of suvorexant in improving sleep and other aspects of health in patients with suboptimally-controlled type 2 diabetes and insomnia. Methods This double-blind, randomized placebo-controlled 3-month trial was conducted using the sequential parallel comparison design (SPCD). Sixty-nine poorly-controlled T2D patients (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 of sleep and diabetes outcomes. Results There were no significant improvements in STST, ISI, or WASO among patients taking suvorexant compared to those taking placebo. There were also no significant changes in any of the exploratory endpoints. Improvements in sleep were associated with improvements in both objective (i.e. HbA1c) and subjective (i.e. Diabetes Distress Scale) measures of diabetes, across treatment assignments. Conclusion Our negative findings for suvorexant efficacy for insomnia in poorly-controlled T2D may be related to inadequate sample size or due to the complex and multiple contributions to insomnia in this patient population. The associations of improved sleep with improvements in diabetes-related metrics across groups highlights the importance of identifying and treating sleeping difficulties in this population. Support (if any) This research was funded by an investigator-initiated grant from Merck Pharmaceuticals.