Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
Eisai Co., Ltd., Hatfield, UK.
Sleep. 2020 Sep 14;43(9). doi: 10.1093/sleep/zsaa123.
To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder.
This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths.
LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.
ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.
评估新型双重食欲素受体拮抗剂雷美替胺（LEM）在失眠症患者中的长期疗效和安全性。
这是一项为期 12 个月的全球性、多中心、随机、双盲、平行分组的 3 期研究，包括 6 个月的安慰剂对照期（本文报道）和随后的 6 个月的单药治疗期（单独报道）。共有 949 名年龄≥18 岁的失眠症患者（失眠症患者）被随机分为安慰剂组或 LEM 组（5 mg [LEM5]或 10 mg [LEM10]），接受口服治疗，并进行分析。睡眠起始和睡眠维持终点通过每日电子睡眠日记数据进行分析。在整个研究过程中监测治疗中出现的不良事件（TEAEs）。
与安慰剂相比，LEM5 和 LEM10 治疗可显著降低患者报告的（主观）入睡潜伏期和入睡后觉醒时间，增加主观睡眠效率，这些差异在第 6 个月和 6 个月期间的大多数时间点均有显著意义，表明 LEM 的长期持续疗效。与安慰剂相比，LEM 治疗组有更多的入睡起始应答者和睡眠维持应答者。与安慰剂相比，接受 LEM 治疗的患者报告在 6 个月后睡眠质量显著改善。大多数 TEAEs 为轻度或中度。TEAE 发生率较低，无死亡病例。
与安慰剂相比，LEM5 和 LEM10 可显著改善失眠症患者的入睡和睡眠维持，且耐受性良好。
ClinicalTrials.gov，NCT02952820；ClinicalTrialsRegister.eu，EudraCT Number 2015-001463-39。
