Clinical Profile of Suvorexant for the Treatment of Insomnia Over 3 Months in Men and Women: Gender Subgroup Analysis of Pooled Phase-3 Data (P4.293)

Objective: To evaluate the clinical profile of suvorexant in gender subgroups. Background: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20mg. Previously-reported Phase-3 trial results showed that suvorexant was effective and generally well-tolerated. Methods: Gender subgroup efficacy analyses were pre-specified and included pooled data from two similar randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in elderly (≥65y) and non-elderly (18-64y) insomnia patients. Two age-adjusted (non-elderly/elderly) dose-regimes of 40/30mg and 20/15mg were evaluated. Fewer patients were assigned to 20/15mg than 40/30mg or placebo. Efficacy was assessed by patient-reported outcomes (PRO), and by objective polysomnography (PSG) endpoints in ~75[percnt] of patients. The pooled safety analyses by gender included data from the 3-month trials plus 3-month data from a safety trial for 40/30mg and placebo. Results: 1264 women and 707 men were included in the efficacy analysis of PRO endpoints. The gender subgroup analyses mirrored the improvements seen for suvorexant 40/30mg and 20/15mg over placebo on PRO and PSG sleep maintenance and onset endpoints in the primary analyses; 95[percnt] CIs excluded zero in favor of suvorexant for the majority of endpoints in both subgroups and similar efficacy was observed across genders (95[percnt] CIs overlapped). 1744 women and 1065 men were included in the safety analyses. Suvorexant was generally well-tolerated in women and men. The most frequent adverse event was somnolence for both 40/30mg (women: 11.1[percnt] vs. 2.3[percnt] for placebo; men: 10.1[percnt] vs. 4.2[percnt] for placebo) and 20/15 mg (women: 8.5[percnt] vs. 2.3[percnt] for placebo; men: 3.4[percnt] vs. 4.2[percnt] for placebo). Somnolence was generally transient and mild-to-moderate in intensity. Conclusions: Suvorexant 20/15mg and 40/30mg were generally effective and well-tolerated by women and men with insomnia. Given that the maximum approved dose is 20mg, the 20/15mg data are the most clinically relevant. Study Support: Merck & Co. Inc., Kenilworth, NJ,USA Disclosure: Dr. Herring has received personal compensation for activities with Merck & Co. Inc., as an employee. Dr. Connor has received personal compensation for activities with Merck & Co., Inc. as an employee. Dr. Snavely has received personal compensation for activities with Merck & Co., Inc. as an employee. Dr. Zhang has received personal compensation for activities with Merck as an employee. Dr. Snyder has received personal compensation for activities for Merck. Dr. Lines has received personal compensation for activities with Merck as an employee. Dr. Michelson has received personal compensation for activities with Merck & Co., Inc. as an employee.