A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder.

INTRODUCTION

This study evaluated the efficacy and safety of lemborexant (LEM), a dual orexin-receptor antagonist, in participants with insomnia disorder in China.

METHODS

E2006-J086-311 (Study 311; NCT04549168), a 1-month, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group study, enrolled adults (≥18 years) with insomnia disorder in China. Pairs of polysomnograms were conducted during a 7-day PBO run-in period (baseline), after the first 2 doses of LEM 10 mg (LEM10) or PBO, and after the last 2 doses at the end of 1 month of treatment. Objective sleep parameter assessments included latency to persistent sleep (LPS; primary endpoint) and secondary endpoints of sleep efficiency, wake after sleep onset (WASO), and total sleep time (TST; exploratory endpoint). Safety data were collected.

RESULTS

Among 194 participants randomized (PBO, n = 100; LEM10, n = 94), the median age was approximately 42 years; most participants were female (PBO: 74.0 %; LEM10: 61.3 %). Following 1 month of treatment, mean (standard deviation [SD]) decreases from baseline in LPS were larger (improved) for the LEM10 treatment group (-39.47 min [46.147 min]) versus PBO (-21.71 min [42.809 min]; post hoc Box-Cox transformation, p = 0.0096). LEM10 demonstrated larger and statistically significant increases from baseline (improvements) in sleep efficiency (p < 0.0001) and TST (p < 0.0001) and significant decreases from baseline (improvement) in WASO (p = 0.0002) versus PBO and was well-tolerated. No new safety signals with LEM were observed in the current study compared with the known safety profile.

CONCLUSIONS

LEM may be an important potential treatment option for patients with insomnia in China.

TRIAL REGISTRATION: ClinicalTrials.gov identifier (first submitted on 09-09-2020): NCT04549168; Study protocol and statistical analysis plan may be accessed at: https://clinicaltrials.gov/study/NCT04549168.