Efficacy and safety of lemborexant in midlife women with insomnia disorder.

ABSTRACT:

Objective

Insomnia is common in midlife women. The efficacy and safety of lemborexant (LEM), a competitive dual orexin receptor antagonist, was assessed for 12 months in a subgroup of midlife women (age, 40-58 y) from Study E2006-G000-303 (Study 303; SUNRISE-2).

Methods

This was a randomized, double-blind, placebo (PBO)-controlled (first 6 mo) study of adults with insomnia disorder ( N = 949). During treatment period 1 (TP1), participants received PBO or LEM 5 mg (LEM5) or 10 mg (LEM10). During TP2 (second 6 mo), LEM participants continued their assigned dose; PBO participants were rerandomized to LEM5 or LEM10. Assessments included patient-reported sleep- and fatigue-related measures and treatment-emergent adverse events.

Results

The midlife female subgroup comprised

SUBMITTER: Terauchi M 

PROVIDER: S-EPMC10389212 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature