Department of Psychiatry, Akita University Graduate School of Medicine, Akita, Japan.
Medical Headquarters Clinical Planning Department, Eisai Co., Ltd, Tokyo, Japan.
Drugs R D. 2024 Jun;24(2):211-226. doi: 10.1007/s40268-024-00462-w. Epub 2024 Jun 6.
A prospective, postmarketing observational study was conducted to evaluate the safety and efficacy of lemborexant (LEM) tablets in daily clinical practice in Japan. No other studies of a similar size have been conducted since the marketing approval of LEM, making this the first report of its kind.
Insomnia patients (n = 550) administered LEM (5-10 mg daily) for the first time were enrolled. Adverse events were collected for target events (somnolence, parasomnia, narcolepsy and associated conditions, suicidal ideation and suicidal behavior). Overall improvement of insomnia symptoms was assessed by the investigator based on the patient's complaint. Subjective sleep onset latency (sSOL) and subjective total sleep time (sTST) were investigated as sleep parameters.
A case report form was obtained from 539 patients. The incidence of adverse drug reactions (ADRs) was 7.65% for somnolence, 1.76% for nightmares, 0.59% for abnormal dreams, and 0.20% for sleep paralysis. No serious ADRs or ADRs related to suicidal ideation or suicidal behavior were observed. The efficacy rate at the final evaluation was 80.83%. Decreased sSOL and increased sTST were observed as assessed starting from Week 8 of treatment.
Based on the results of this study, the safety result was consistent with the safety profile described in the current package insert. Efficacy results also indicated that LEM is clinically useful.
开展了一项前瞻性、上市后观察性研究，以评估在日本日常临床实践中lemborexant（LEM）片剂的安全性和疗效。在 LEM 获得批准后，尚未进行其他类似规模的研究，因此这是首例此类报告。
首次接受 LEM（每日 5-10mg）治疗的失眠患者（n=550）入组。收集目标事件（嗜睡、睡眠相关异常、发作性睡病及相关情况、自杀意念和自杀行为）的不良事件。根据患者的主诉，研究者评估失眠症状的整体改善情况。主观入睡潜伏期（sSOL）和主观总睡眠时间（sTST）作为睡眠参数进行研究。
从 539 名患者中获得了病例报告表。嗜睡的不良反应（ADR）发生率为 7.65%，梦魇为 1.76%，异常梦境为 0.59%，睡眠瘫痪为 0.20%。未观察到严重 ADR 或与自杀意念或自杀行为相关的 ADR。最终评估时的疗效率为 80.83%。从治疗第 8 周开始，观察到 sSOL 缩短和 sTST 增加。
根据本研究结果，安全性结果与当前说明书中描述的安全性特征一致。疗效结果也表明 LEM 具有临床应用价值。
