Abstract Study Objectives To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder. Methods 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. Results 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. Conclusions LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated. Clinical trial registration ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39

中文翻译：

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与安慰剂相比，lemborexant 在成人失眠症中的长期疗效和耐受性：来自 3 期随机临床试验 SUNRISE 2 的结果

摘要 研究目的 评估 lemborexant (LEM)（一种新型双重食欲素受体拮抗剂）与安慰剂在成人失眠症中的长期疗效和安全性。方法 这是一项为期 12 个月、全球、多中心、随机、双盲、平行组的 3 期研究，包括 6 个月的安慰剂对照期（在此报告），然后是 6 个月的仅积极治疗期（单独报告）。共有 949 名失眠参与者（年龄≥18 岁）被随机分组​​，接受口服剂量的安慰剂或 LEM（5 毫克 [LEM5] 或 10 毫克 [LEM10]）治疗并进行分析。从每日电子睡眠日记数据中分析睡眠开始和睡眠维持终点。在整个研究过程中监测治疗出现的不良事件 (TEAE)。结果 LEM5 和 LEM10 与安慰剂相比，患者报告的（主观）入睡潜伏期和入睡后主观觉醒比基线降低，主观睡眠效率比基线增加明显更大。在第 6 个月结束时观察到优于安慰剂的显着益处，并且在 6 个月期间的大多数时间点进行评估，表明 LEM 的长期持续疗效。与安慰剂相比，LEM 治疗观察到显着更高百分比的入睡反应者和睡眠维持反应者。接受 LEM 治疗的参与者报告称，与安慰剂相比，6 个月后睡眠质量显着改善。大多数 TEAE 为轻度或中度。严重 TEAE 的发生率很低，没有死亡。结论与安慰剂相比，LEM5 和 LEM10 对失眠症患者的入睡和睡眠维持具有显着益处，并且耐受性良好。临床试验注册ClinicalTrials.gov，NCT02952820；ClinicalTrialsRegister.eu，EudraCT 编号 2015-001463-39