lemborexant对失眠症患者的疗效和安全性：一项系统综述和荟萃分析

IF 3.4 2区医学 Q1 CLINICAL NEUROLOGY

Sleep medicine Pub Date : 2025-09-23 DOI:10.1016/j.sleep.2025.106823

Allahdad Khan , Shree Rath , Hamza Khan , Umama Alam , Hammad Javaid , Zaryab Bacha , Asad Ali Ahmed Cheema , Umair Hayat , Muhammad Abdullah Ali , Abdul Qadeer , Charles Dominic Ward , Raheel Ahmed

{"title":"lemborexant对失眠症患者的疗效和安全性：一项系统综述和荟萃分析","authors":"Allahdad Khan , Shree Rath , Hamza Khan , Umama Alam , Hammad Javaid , Zaryab Bacha , Asad Ali Ahmed Cheema , Umair Hayat , Muhammad Abdullah Ali , Abdul Qadeer , Charles Dominic Ward , Raheel Ahmed","doi":"10.1016/j.sleep.2025.106823","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Insomnia is a prevalent sleep disorder that significantly impacts quality of life and overall health. Lemborexant, a dual orexin receptor antagonist, has emerged as a promising treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Lemborexant in adults with insomnia.</div></div><div><h3>Methods</h3><div>We systematically searched PubMed, Embase, Cochrane, and clinicaltrials.gov through March 5, 2025, for randomized controlled trials (RCTs) comparing lemborexant with placebo. Primary outcomes included changes in wake after sleep onset (WASO), sleep efficiency, and sleep onset latency. Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and headache. Data were synthesized using a random-effects model and assessed for heterogeneity. Meta-analyses used a random-effects model and heterogeneity was assessed using the I<sup>2</sup> statistic.</div></div><div><h3>Results</h3><div>Six RCTs involving 2257 patients were included. Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to −12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced sleep onset latency (MD: 10.85 min; 95 % CI: 18.47 to −3.23). Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference in overall TEAEs or headache compared to placebo.</div></div><div><h3>Conclusion</h3><div>Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety.</div></div>","PeriodicalId":21874,"journal":{"name":"Sleep medicine","volume":"136 ","pages":"Article 106823"},"PeriodicalIF":3.4000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysis\",\"authors\":\"Allahdad Khan , Shree Rath , Hamza Khan , Umama Alam , Hammad Javaid , Zaryab Bacha , Asad Ali Ahmed Cheema , Umair Hayat , Muhammad Abdullah Ali , Abdul Qadeer , Charles Dominic Ward , Raheel Ahmed\",\"doi\":\"10.1016/j.sleep.2025.106823\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Insomnia is a prevalent sleep disorder that significantly impacts quality of life and overall health. Lemborexant, a dual orexin receptor antagonist, has emerged as a promising treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Lemborexant in adults with insomnia.</div></div><div><h3>Methods</h3><div>We systematically searched PubMed, Embase, Cochrane, and clinicaltrials.gov through March 5, 2025, for randomized controlled trials (RCTs) comparing lemborexant with placebo. Primary outcomes included changes in wake after sleep onset (WASO), sleep efficiency, and sleep onset latency. Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and headache. Data were synthesized using a random-effects model and assessed for heterogeneity. Meta-analyses used a random-effects model and heterogeneity was assessed using the I<sup>2</sup> statistic.</div></div><div><h3>Results</h3><div>Six RCTs involving 2257 patients were included. Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to −12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced sleep onset latency (MD: 10.85 min; 95 % CI: 18.47 to −3.23). Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference in overall TEAEs or headache compared to placebo.</div></div><div><h3>Conclusion</h3><div>Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety.</div></div>\",\"PeriodicalId\":21874,\"journal\":{\"name\":\"Sleep medicine\",\"volume\":\"136 \",\"pages\":\"Article 106823\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Sleep medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1389945725004988\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sleep medicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1389945725004988","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景：失眠是一种普遍的睡眠障碍，严重影响生活质量和整体健康。Lemborexant是一种双食欲素受体拮抗剂，已成为一种有希望的治疗方法。本系统综述和荟萃分析旨在评价Lemborexant治疗成人失眠症的有效性和安全性。方法：我们系统地检索PubMed、Embase、Cochrane和clinicaltrials.gov，检索到2025年3月5日，以比较lemborexant和安慰剂的随机对照试验（rct）。主要结局包括睡眠后觉醒（WASO）、睡眠效率和睡眠开始潜伏期的变化。安全性结局包括治疗出现的不良事件（teae）、治疗相关的teae和头痛。使用随机效应模型综合数据并评估异质性。meta分析采用随机效应模型，异质性评估采用I2统计量。结果纳入6项随机对照试验，共2257例患者。Lemborexant显著降低了WASO (MD: 20.73 min; 95% CI: 28.58至- 12.88)，改善了睡眠效率（MD: 4.84%; 95% CI: 2.69至7.00），减少了睡眠发作潜伏期（MD: 10.85 min; 95% CI: 18.47至- 3.23）。Lemborexant与治疗相关teae的高风险相关（RR: 1.82; 95% CI: 1.41至2.34），但与安慰剂相比，总体teae或头痛没有显着差异。结论lemborexant对改善失眠患者的睡眠参数有显著疗效，且具有良好的安全性。这些发现支持其作为一种有效的药理选择的作用。需要进一步的高质量研究来证实其有效性和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysis

Background

Insomnia is a prevalent sleep disorder that significantly impacts quality of life and overall health. Lemborexant, a dual orexin receptor antagonist, has emerged as a promising treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Lemborexant in adults with insomnia.

Methods

We systematically searched PubMed, Embase, Cochrane, and clinicaltrials.gov through March 5, 2025, for randomized controlled trials (RCTs) comparing lemborexant with placebo. Primary outcomes included changes in wake after sleep onset (WASO), sleep efficiency, and sleep onset latency. Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and headache. Data were synthesized using a random-effects model and assessed for heterogeneity. Meta-analyses used a random-effects model and heterogeneity was assessed using the I² statistic.

Results

Six RCTs involving 2257 patients were included. Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to −12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced sleep onset latency (MD: 10.85 min; 95 % CI: 18.47 to −3.23). Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference in overall TEAEs or headache compared to placebo.

Conclusion

Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Sleep medicine 医学-临床神经学

CiteScore

8.40

自引率

6.20%

发文量

1060

审稿时长

49 days

期刊介绍： Sleep Medicine aims to be a journal no one involved in clinical sleep medicine can do without. A journal primarily focussing on the human aspects of sleep, integrating the various disciplines that are involved in sleep medicine: neurology, clinical neurophysiology, internal medicine (particularly pulmonology and cardiology), psychology, psychiatry, sleep technology, pediatrics, neurosurgery, otorhinolaryngology, and dentistry. The journal publishes the following types of articles: Reviews (also intended as a way to bridge the gap between basic sleep research and clinical relevance); Original Research Articles; Full-length articles; Brief communications; Controversies; Case reports; Letters to the Editor; Journal search and commentaries; Book reviews; Meeting announcements; Listing of relevant organisations plus web sites.