0551 Consistency of Objective Results on Sleep Onset and Sleep Maintenance Parameters from Global Studies of Lemborexant

Abstract Introduction When selecting a hypnotic for patients, it is important to know whether there are differences in response based on age, sex, and/or race. To increase patient diversity across the clinical development program for lemborexant (LEM), a dual orexin-receptor antagonist approved to treat adults with insomnia, 2 additional studies were conducted beyond the original Phase 3 studies that enrolled patients in North America, Europe, and Japan, but few from South Korea and none from China. Since studies have now completed in these latter countries, it is possible to compare results on polysomnography (PSG) from the 3 studies conducted globally with South Korea or China. Methods Each study was 1-month, multiple-site, randomized, and placebo-controlled enrolling participants with insomnia disorder. Study E2006-G000-304 (Study 304) included females ≥55 years/males ≥65 years with confirmed sleep maintenance insomnia. Studies E2006-J086-311 (Study 311) and E2006-J082-204 (Study 204) enrolled adults ≥18 and 19–80 years, respectively, with confirmed sleep onset and/or maintenance insomnia. PSGs were obtained during the placebo run-in (baseline) and at end-of-treatment. Each study included LEM 10 mg (LEM10) and placebo. Study 304 also included zolpidem extended-release, and Studies 204 and 304 included LEM 5 mg (not discussed here). Change from baseline to Day 30 in latency-to-persistent-sleep (LPS), sleep efficiency (SE), and wake-after-sleep-onset (WASO) were calculated. Safety and pharmacokinetics (PKs) were assessed. Results Results from the 3 PSG studies (204, 304, and 311) were compared using 95% confidence intervals (CIs). LEM10 led to larger changes from baseline in LPS, SE, and WASO compared to placebo. The CIs overlapped, demonstrating that the direction and magnitude of effect were similar. LEM PKs from Studies 204 and 311 were comparable to Study 304. Based on the totality of LEM data from clinical trials, analyses show that oral clearance was not affected by race. In Studies 204 and 311, like global Study 304, overall incidence of LEM10 treatment-emergent adverse events was similar to placebo. In all studies, most TEAEs were mild/moderate. Conclusion These data support the view that LEM is an effective and well-tolerated treatment for patients with insomnia without influence by race/national origin. Support (if any) Eisai, Inc, and Eisai Co., Ltd.

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