Khazaie Habibolah, Sadeghi Masoud, Khazaie Sepideh, Hirshkowitz Max, Sharafkhaneh Amir
Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Front Psychiatry. 2022 Dec 12;13:1070522. doi: 10.3389/fpsyt.2022.1070522. eCollection 2022.
Recent treatment guidelines for chronic insomnia recommend pharmacological and non-pharmacological therapies. One of the contemporary drug options for insomnia includes dual orexin receptor antagonist (DORA), such as suvorexant and lemborexant. We conducted a systematic review and meta-analysis for the treatment of insomnia with suvorexant and lemborexant based on randomized, double-blind, placebo-controlled Trials.
We conducted a comprehensive search on three databases (PubMed/Medline, Web of Science, and Cochrane Library) till August 14, 2021, without any restrictions to retrieve the relevant articles. The effect sizes were computed presenting the pooled mean difference or risk ratio along with 95% confidence interval of each outcome.
Our search showed eight articles (five for suvorexant and three for lemborexant). Results of diary measures, rating scales, polysomnography results, treatment discontinuation, and adverse events were measured. All efficacy outcome measures favorably and significantly differed in the suvorexant compared to placebo. Safety profile did not differ significantly except for somnolence, excessive daytime sleepiness/sedation, fatigue, back pain, dry mouth, and abnormal dreams. Important adverse events including hallucinations, suicidal ideation/behavior and motor vehicle accidents did not differ between suvorexant and placebo. All the efficacy outcomes significantly differed between lemborexant 5 and lemborexant 10 compared to placebo. Somnolence rate for lemborexant 5 and lemborexant 10 and nightmare for lemborexant 10 were significantly higher than placebo.
The present meta-analysis reported that suvorexant and lemborexant are efficacious and safe agents for the patients with insomnia. Further data in patients with insomnia and various comorbid conditions are needed.
近期慢性失眠治疗指南推荐了药物治疗和非药物治疗方法。失眠的当代药物选择之一包括双重食欲素受体拮抗剂（DORA），如苏沃雷生和伦扎雷生。我们基于随机、双盲、安慰剂对照试验，对苏沃雷生和伦扎雷生治疗失眠进行了系统评价和荟萃分析。
我们在三个数据库（PubMed/Medline、科学网和考克兰图书馆）进行了全面检索，直至2021年8月14日，检索时没有任何限制，以获取相关文章。计算效应量，呈现合并平均差或风险比以及每个结局的95%置信区间。
我们的检索显示有8篇文章（5篇关于苏沃雷生，3篇关于伦扎雷生）。测量了日记测量、评分量表、多导睡眠图结果、治疗中断和不良事件的结果。与安慰剂相比，苏沃雷生在所有疗效结局指标上均表现良好且有显著差异。除嗜睡、日间过度嗜睡/镇静、疲劳、背痛、口干和异常梦境外，安全性方面没有显著差异。包括幻觉、自杀意念/行为和机动车事故在内的重要不良事件在苏沃雷生组和安慰剂组之间没有差异。与安慰剂相比，5mg伦扎雷生和10mg伦扎雷生在所有疗效结局上均有显著差异。5mg伦扎雷生和10mg伦扎雷生的嗜睡率以及10mg伦扎雷生的噩梦发生率均显著高于安慰剂。
本荟萃分析报告称，苏沃雷生和伦扎雷生对失眠患者是有效且安全的药物。还需要更多关于失眠患者及各种合并症患者的数据。
