P069 Efficacy and safety of Lemborexant in Asian adults with insomnia

Abstract Introduction This analysis evaluated the efficacy and safety of lemborexant (LEM), a competitive dual-orexin-receptor-antagonist, in Asian participants with insomnia disorder. Methods E2006-G000-303 (Study 303; NCT02952820; 12-month; global, only Asian participants included here) and E2006-J086-311 (Study 311; NCT04549168; 1-month; China) were randomised, placebo (PBO)-controlled (Study 303: first 6 months), double-blind, parallel-group, phase 3 studies in adults with insomnia disorder. Outcomes were calculated using sleep diary data across the first month of treatment (LEM 10mg [LEM10] and PBO; first 7/last 7 nights [7N]). Safety data were collected. Results Baseline median (quartile [Q]1], Q3) subjective sleep onset latency (sSOL) values (min) for LEM10 and PBO, respectively, were 60.00 (35.00, 90.00) and 49.00 (34.29, 72.86) for Study 303 (n = 116) and 80.71 (50.00, 102.43) and 74.86 (58.29, 113.43) for Study 311 (n = 193). In Study 303, decreases (improvements) from baseline in sSOL were larger with LEM10 versus PBO and reached statistical significance for the first 7N (median [Q1, Q3]: LEM10: −11.73 [−30.00, −1.43]; PBO: −4.29 [−20.00, 3.57]; p=.0087). Decreases (improvements) reached significance at both timepoints in Study 311 (first 7N: LEM10: −17.00 [−42.86, −2.14]; PBO: −11.86 [−25.00, 5.17]; p=.0010; last 7N: LEM10: −29.29 [−57.14, −10.00]; PBO: −20.46 [−38.71, −3.43]; p=.0063). Larger decreases (improvements) from baseline in subjective wake after sleep onset with LEM10 versus PBO were observed in both studies, reaching statistical significance in Study 311 (first 7N). LEM10 was well-tolerated. Discussion LEM treatment improved subjective sleep parameters and was well-tolerated in Asian participants with insomnia disorder in these 2 studies with limited sample sizes.