A phase 2 trial evaluating polysomnography outcomes and safety of lemborexant in Korean adults with insomnia disorder

A phase 2 trial evaluating polysomnography outcomes and safety of lemborexant in Korean adults with insomnia disorder. Download PDF Abstract Lemborexant (LEM), a dual-orexin-receptor-antagonist, was evaluated in this study of Korean participants with insomnia disorder. Study E2006-J082-204 (Study 204), a 1-month, multicenter, double-blind, placebo (PBO)-controlled, parallel-group study, evaluated LEM 5 mg (LEM5) or LEM 10 mg (LEM10) in participants aged 19–80 years with insomnia disorder (sleep efficiency [SE] ≤ 85%; latency to persistent sleep [LPS] ≥ 30 min).

Korean participants were randomized (2:2:1) to LEM5, LEM10, or PBO, respectively, and received study drug immediately before bedtime for 30 days. Polysomnograms were conducted during an ~ 14-day single-blind PBO run-in (baseline) and after 1 month (Day 30). Changes from baseline in LPS (min; log-transformed; primary endpoint [LEM5 only]; secondary endpoint [LEM10 only]), SE (%; secondary endpoint), wake after sleep onset (WASO; min; exploratory endpoint), and total sleep time (TST; min; exploratory endpoint) were evaluated.

The full analysis set comprised 64 participants (PBO, n = 13; LEM5, n = 25; LEM10, n = 26). At Day 30, decreases (improvements) from baseline in LPS and WASO were larger with LEM versus PBO.

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