Subedi Roshan, Singh Rajshree, Thakur Rahul Kumar, K C Bibek, Jha Divyanshu, Ray Barun Kumar
Tribhuvan University Teaching Hospital, Institute of Medicine, Kathmandu, Nepal.
Nepalese Army Institute of Health Sciences, College of Medicine, Kathmandu, Nepal.
Sleep Med. 2020 Nov;75:510-521. doi: 10.1016/j.sleep.2020.09.019. Epub 2020 Sep 21.
Excessive daytime sleepiness (EDS) is the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times. Solriamfetol is a selective norepinephrine-dopamine reuptake inhibitor approved for EDS. This review was done to assess the efficacy and safety of solriamfetol in patients with EDS in narcolepsy or OSA.
A systematic search of the electronic database was conducted for relevant studies. Any randomized controlled trial with outcome measures on the efficacy or safety of solriamfetol in EDS were eligible for inclusion. The primary outcomes were mean difference in the maintenance of wakefulness test (MWT), Epworth sleepiness scale (ESS) score, and risk ratio of adverse events. The random-effects model was used to calculate pooled effect estimates.
We identified 336 records from the database search. We analyzed eight articles reported from six clinical trials. We pooled outcome measures from five trials. The overall mean difference for MWT was 9.93 min (95% CI: 8.25-11.61), and the mean difference of ESS score was -4.44 (95% CI: -5.50 to -3.38), both in favor of solriamfetol over placebo. The overall risk ratio of adverse events with solriamfetol was 1.47 (95% CI: 1.28-1.69). The most common adverse events reported were headache, nausea, decreased appetite, anxiety, nasopharyngitis, and insomnia.
Solriamfetol is efficacious and has a favorable safety profile in the treatment of EDS in patients with narcolepsy and OSA. Solriamfetol is well tolerated and may be recommended for the treatment of EDS in these patients.
日间过度嗜睡（EDS）是指在白天主要清醒时段无法保持清醒和警觉，睡眠会在无意之中或不适当的时间发生。索利那非是一种被批准用于治疗EDS的选择性去甲肾上腺素-多巴胺再摄取抑制剂。本综述旨在评估索利那非在发作性睡病或阻塞性睡眠呼吸暂停（OSA）患者中治疗EDS的疗效和安全性。
对电子数据库进行系统检索以查找相关研究。任何以索利那非治疗EDS的疗效或安全性为结局指标的随机对照试验均符合纳入标准。主要结局指标为清醒维持试验（MWT）的平均差异、爱泼沃斯嗜睡量表（ESS）评分以及不良事件的风险比。采用随机效应模型计算合并效应估计值。
我们从数据库检索中识别出336条记录。我们分析了六项临床试验报告的八篇文章。我们汇总了五项试验的结局指标。MWT的总体平均差异为9.93分钟（95%置信区间：8.25 - 11.61），ESS评分的平均差异为 -4.44（95%置信区间：-5.50至-3.38），两者均显示索利那非优于安慰剂。索利那非不良事件的总体风险比为1.47（95%置信区间：1.28 - 1.69）。报告的最常见不良事件为头痛、恶心、食欲减退、焦虑、鼻咽炎和失眠。
索利那非在治疗发作性睡病和OSA患者的EDS方面有效且安全性良好。索利那非耐受性良好，可推荐用于治疗这些患者的EDS。
