Brain and Nerve Research Laboratory, Institute of Stroke Research, Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Brain and Nerve Research Laboratory, Institute of Stroke Research, Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.
Medicine (Baltimore). 2023 Feb 17;102(7):e32754. doi: 10.1097/MD.0000000000032754.
Daridorexant is a novel dual orexin receptor antagonist that has shown efficacy as a treatment for insomnia in multiple randomized clinical trials. However, the efficacy and safety of daridorexant for treatment of insomnia disorder has not been characterized comprehensively in the literature. Therefore, we performed a meta-analysis of available studies. We performed a meta-analysis to systematically evaluate the efficacy and safety of daridorexant for treatment of insomnia disorder.
MEDLINE, Embase, Cochrane Library, and Clinicaltrials.gov for randomized controlled trials were systematically searched up to February 2022. Relative risk and standard mean difference were used to evaluate clinical outcomes.
We pooled 2271 patients from 4 randomized clinical trials, and evaluated efficacy endpoints. We found that 50 mg of daridorexant was superior to placebo for 4 efficacy outcomes including wake time after sleep onset, latency to persistent sleep, subjective total sleep time, and Insomnia Daytime Symptoms and Impacts Questionnaire domain score (P < .05). In addition, there were no significant differences (P > .05) in adverse events between daridorexant and placebo.
Different dosages of daridorexant were tested for treatment of insomnia; however, 5 and 10 mg are not available because of issues of suboptimal effectiveness. Daridorexant showed better efficacy and safety for treatment of insomnia disorder at doses of 25 and 50 mg.
达力雷克斯坦是一种新型双重食欲素受体拮抗剂，已在多项随机临床试验中证明对失眠症的疗效。然而，达力雷克斯坦治疗失眠症的疗效和安全性尚未在文献中全面描述。因此，我们对现有研究进行了荟萃分析。我们进行了荟萃分析，以系统评估达力雷克斯坦治疗失眠症的疗效和安全性。
系统检索了 MEDLINE、Embase、Cochrane 图书馆和 Clinicaltrials.gov 中的随机对照试验，检索时间截至 2022 年 2 月。相对风险和标准均数差用于评估临床结局。
我们汇总了 4 项随机临床试验中的 2271 名患者，并评估了疗效终点。我们发现，达力雷克斯坦 50mg 组在包括入睡后觉醒时间、持续睡眠潜伏期、主观总睡眠时间和失眠日间症状和影响问卷（Insomnia Daytime Symptoms and Impacts Questionnaire，IDSI）领域评分在内的 4 项疗效结局上优于安慰剂（P<0.05）。此外，达力雷克斯坦与安慰剂之间不良事件发生率无显著差异（P>0.05）。
不同剂量的达力雷克斯坦已被用于治疗失眠症，但由于疗效不佳，5mg 和 10mg 剂量尚未上市。达力雷克斯坦 25mg 和 50mg 剂量治疗失眠症的疗效和安全性更好。
