Impact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder.

TitleImpact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder.
Publication TypeJournal Article
Year of Publication2022
AuthorsRoth, T, Rosenberg, R, Morin, CM, Yardley, J, Pinner, K, Perdomo, C, Atkins, N, Pappadopulos, E, Malhotra, M, Moline, M
JournalSleep Med
Volume90
Pagination249-257
Date Published2022 02
ISSN1878-5506
KeywordsAdult, Double-Blind Method, Humans, Pyridines, Pyrimidines, Sleep Initiation and Maintenance Disorders, Treatment Outcome
Abstract

OBJECTIVE/BACKGROUND: Evaluate changes in insomnia severity in subjects with moderate to severe insomnia (Insomnia Severity Index [ISI] score ≥15) treated for 12 months nightly with lemborexant.PATIENTS/METHODS: This phase 3 randomized study comprised two 6-month treatment periods. In Period 1, 949 subjects were randomized to placebo, lemborexant 5 mg (LEM5) or 10 mg (LEM10). In Period 2, placebo subjects were rerandomized to LEM5 or LEM10; subjects initially randomized to lemborexant continued their assigned treatment. Insomnia severity was assessed using baseline ISI and 1-, 3-, 6-, 9-, and 12-month post-treatment scores.RESULTS: Mean ISI scores improved significantly across treatment groups and disease severities, with greater decreases from baseline in the LEM5 and LEM10 versus placebo groups at months 1 (-7.1, -7.2, -5.2, respectively), 3 (-8.6, -8.9, -6.1, respectively), and 6 (-9.9, -9.8, -7.2 respectively); ISI score improvements were maintained with LEM5 and LEM10 at months 9 (-11.1 and -11.2, respectively) and 12 (-11.5 and -11.2, respectively). At months 1, 3, and 6, significantly more treatment responders (≥7-point ISI score decrease from baseline) were observed with LEM5 (44%-57%) and LEM10 (44%-52%) versus placebo (30%-41%). At months 1, 3, and 6, more remitters (ISI total score <10 and < 8) were observed with LEM5 (30%-44% and 22%-34%, respectively) and LEM10 (31%-41% and 22%-31%, respectively) versus placebo (18%-28% and 11%-21%, respectively).CONCLUSIONS: Lemborexant significantly reduced insomnia severity for 12 months and increased clinically meaningful response and remission rates versus placebo.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.

DOI10.1016/j.sleep.2022.01.024
Alternate JournalSleep Med
PubMed ID35220140