Department of Pharmacology, All India Institute of Medical Sciences, Rajkot, India.
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India.
Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
Insomnia is a multi-factorial disorder with conventional treatment options that are not satisfactory for many patients. This metaanalysis analyzed the safety and efficacy of daridorexant.
An electronic database search for RCTs was conducted on Medline via PubMed, Cochrane, and Clinicaltrials.gov using the terms 'Daridorexant,' 'RCT,' 'Insomnia' trials evaluating the efficacy and/or safety of daridorexant for insomnia were included. The data were synthesized using Cochrane review manager version 5.4.1. Cochrane risk of bias 2.0 tool and GRADEpro-GDT were used to assess the methodological and evidence quality, respectively.
Of 109 searched studies, four trials were included. The risk of treatment-emergent adverse events with 25 mg daridorexant [risk ratio (RR) = 1.12 (0.88, 1.43), = 0.36; I = 0%] and 50 mg daridorexant [RR = 1.25 (0.88, 1.79), = 0.22; I = 28%] and serious adverse events with 25 mg [RR = 0.86 (0.23, 3.19), = 0.82, I = 56%] and 50 mg [RR = 1.32 (0.29, 6.08), = 0.72, I = 52%] was comparable to placebo [Moderate quality evidence]. Risk of nasopharyngitis was also comparable to placebo. The efficacy parameters like wake after sleep onset, latency to persistent sleep, and subjective total sleep time showed significant improvement with daridorexant. The risk of bias is low for three studies and some concern for one.
Daridorexant is a safer and efficacious agent for induction and maintenance of sleep for chronic insomnia.
The registration number is CRD42022335233.
www.clinicaltrials.gov identifiers are NCT03575104, NCT03545191, NCT03679884, and NCT02839200).
失眠是一种多因素疾病，常规治疗方案对许多患者并不满意。本荟萃分析分析了达理多雷克斯坦的安全性和疗效。
通过 Medline 上的 PubMed、Cochrane 和 Clinicaltrials.gov 电子数据库搜索 RCT，使用术语“达理多雷克斯坦”、“RCT”、“失眠”，评估达理多雷克斯坦治疗失眠的疗效和/或安全性的试验被纳入研究。使用 Cochrane 评论经理版本 5.4.1 对数据进行综合分析。Cochrane 偏倚风险 2.0 工具和 GRADEpro-GDT 分别用于评估方法学和证据质量。
在 109 项搜索研究中，有 4 项试验被纳入。25mg 达理多雷克斯坦治疗引起的不良事件风险[风险比（RR）=1.12（0.88，1.43），=0.36；I=0%]和 50mg 达理多雷克斯坦[RR=1.25（0.88，1.79），=0.22；I=28%]和严重不良事件的风险25mg[RR=0.86（0.23，3.19），=0.82，I=56%]和 50mg[RR=1.32（0.29，6.08），=0.72，I=52%]与安慰剂相当[中等质量证据]。鼻咽炎的风险也与安慰剂相当。达理多雷克斯坦在睡眠潜伏期、睡眠后觉醒和主观总睡眠时间等疗效参数方面显示出显著改善。三项研究的偏倚风险较低，一项研究存在一些关注。
达理多雷克斯坦是一种更安全、有效的慢性失眠诱导和维持睡眠的药物。
注册号为 CRD42022335233。
www.clinicaltrials.gov 标识符为 NCT03575104、NCT03545191、NCT03679884 和 NCT02839200）。
