Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study.

ABSTRACT:

Objective

To evaluate effects of lemborexant (LEM), a dual orexin receptor antagonist, on next-morning sleep propensity assessed by a modified Multiple Sleep Latency Test (M-MSLT) in adults with insomnia disorder.

Methods

Study 107 (E2006-A001-107) was a phase 1, randomized, double-blind, four-period crossover study. Subjects (n = 69) received oral single-dose placebo, LEM 5 mg (LEM5), and LEM 10 mg (LEM10) at bedtime in periods 1-3 in a randomized crossover and open-label flurazepam 30 mg in period 4. After an 8-hour overnight sleep opportunity, the M-MSLT measured average sleep onset latency (SOL). Mean change from baseline in average SOL versus placebo of -6.0 min or more was considered clinically meaningful. Other sleep propensity assessments included the proporti

SUBMITTER: Mayleben D 

PROVIDER: S-EPMC10104417 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature