查看更多>>摘要：? 2022 The Author(s)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.
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Elsevier