Graduation Program in Medical Sciences, University of Brasilia, Brasília/DF, 70910-900, Brazil; Geriatric Medical Centre, University Hospital of Brasilia, SGAN 605 Av. L2 Norte, Brasilia/DF, 70840-901, Brazil.
Graduation Program in Medical Sciences, University of Brasilia, Brasília/DF, 70910-900, Brazil.
Eur Neuropsychopharmacol. 2021 Sep;50:75-92. doi: 10.1016/j.euroneuro.2021.04.013. Epub 2021 May 20.
Considering the global increase in use of Z-drugs to treat insomnia, the study objective was to conduct a systematic review on the efficacy and safety of zopiclone to treat sleep disorders in older adults compared to other sedative-hypnotics, to placebo or to non-pharmacological interventions. The literature search for original reports - clinical trials, cohort studies and cross-sectional, observational investigations - was done in eleven databases and web search engines followed PRISMA guidelines, and methodological quality was assessed using the Risk of Bias tool in the Cochrane Reviewers' Handbook. The search resulted in 12 randomized, placebo-controlled clinical trials along with 2 open studies and 2 observational reports. Overall, the studies suggest that zopiclone is effective to treat insomnia by reducing sleep latency, nocturnal awakenings and wake time after sleep onset while increasing total sleep time, with probable effects on sleep architecture. Zopiclone was found to be fairly tolerated, to induce a low rate of adverse events with non-severe impact on psychomotor or cognitive performance and to produce no major harm to the overall well-being and daily living abilities. However, the quality of most studies was classified as low or unclear. Though the studies available support benefits from zopiclone use, there is still a need for further evidence on long-term effects, tolerability and safety in the treatment of older adults by means of high-quality trials.
考虑到全球范围内使用 Z 药物治疗失眠的情况不断增加,本研究旨在对佐匹克隆治疗老年睡眠障碍的疗效和安全性进行系统评价,将其与其他镇静催眠药、安慰剂或非药物干预措施进行比较。通过在 11 个数据库和网络搜索引擎中进行文献检索,遵循 PRISMA 指南,并使用 Cochrane 评论员手册中的偏倚风险工具评估方法学质量,检索到了原始报告——临床试验、队列研究和横断面、观察性研究。共纳入 12 项随机、安慰剂对照临床试验,2 项开放研究和 2 项观察性报告。总体而言,这些研究表明,佐匹克隆通过缩短睡眠潜伏期、夜间觉醒次数和睡眠起始后醒来时间,同时增加总睡眠时间,对睡眠结构有一定影响,从而有效治疗失眠。佐匹克隆耐受性良好,引起的不良反应发生率低,对精神运动或认知表现影响不大,对整体健康和日常生活能力无重大危害。然而,大多数研究的质量被归类为低或不清楚。尽管现有研究支持佐匹克隆的使用带来的益处,但仍需要高质量试验进一步证明其在治疗老年人方面的长期疗效、耐受性和安全性。