Effect of Lemborexant on Daytime Functioning in Adults With Insomnia

Insomnia and some insomnia treatments can impact an individual's daytime functioning. Here, we performed post hoc analyses of patient-reported outcomes from a phase 3 clinical trial to assess the impact of lemborexant (LEM), a dual orexin receptor antagonist, on daytime functioning. Adults with insomnia were randomized 1:1:1 to receive placebo, LEM 5 mg (LEM5) or LEM 10 mg (LEM10) for 6 months. Treatment impact on subjects' perceptions of their insomnia symptoms and daytime functioning was assessed by the Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS) questionnaires. Safety assessments included monitoring of treatment emergent adverse events. < .05). LEM5 and LEM10 treatment was well tolerated. Improved insomnia symptoms with LEM treatment may translate into improved daytime functioning, suggesting LEM may be appropriate for adults experiencing daytime impairment with their nighttime symptoms. ClinicalTrials.gov identifier: NCT02952820. .