Study Objectives:

This post-hoc analysis characterized the weekly incidence and overall duration of common early-onset treatment-emergent adverse events (TEAEs) during solriamfetol treatment.

Methods:

Participants (obstructive sleep apnea [OSA], N=474; narcolepsy, N=236) were randomized to 12 weeks of placebo or solriamfetol 37.5 (OSA only), 75, 150, or 300 mg. For common early-onset TEAEs (those occurring in ≥5% of participants in any solriamfetol dose group and with a higher incidence than that observed in placebo-treated participants during week 1), the incidence of new occurrence or change in severity over time was calculated for each subsequent study week. Data were analyzed separately for each study and summarized by placebo and combined solriamfetol groups.

Results:

Common early-onset TEAEs (at doses ≤150 mg, ie, approved doses) included headache (OSA, 5.1%; narcolepsy, 8.5%), nausea (OSA, 2.5%; narcolepsy, 4.2%), decreased appetite (OSA, 4.2%; narcolepsy, 5.9%), as well as anxiety (2.1%), insomnia (1.3%), and feeling jittery (3.0%) in OSA and dry mouth (4.2%) in narcolepsy. Incidence of common early-onset TEAEs was highest at week 1 and decreased over time. In OSA at doses ≤150 mg, headache, nausea, and feeling jittery had median durations ≤8 days, whereas decreased appetite, anxiety, and insomnia had longer durations. In narcolepsy at doses ≤150 mg, headache and nausea had median durations ≤8 days, whereas decreased appetite and dry mouth had longer durations. Most TEAEs were mild to moderate in severity.

Conclusions:

Common early-onset TEAEs with solriamfetol are limited in duration, with the majority subsiding during the first week of treatment.

Clinical Trial Registration:

NCT02348593; NCT02348606

中文翻译：

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索利安非托治疗阻塞性睡眠呼吸暂停和发作性睡病患者日间过度嗜睡的随机对照试验中常见早发不良事件的发生率和持续时间

 学习目标：

这项事后分析描述了 solriamfetol 治疗期间常见的早发治疗突发不良事件 (TEAE) 的每周发生率和总持续时间。

 方法：

参与者（阻塞性睡眠呼吸暂停 [OSA]，N=474；发作性睡病，N=236）被随机分配接受 12 周的安慰剂或 solriamfetol 37.5（仅 OSA）、75、150 或 300 mg。对于常见的早发性 TEAE（在任何 solriamfetol 剂量组中，≥5% 的参与者发生这些事件，并且其发生率高于在第 1 周安慰剂治疗的参与者中观察到的发生率），随着时间的推移，新发生的发生率或严重程度的变化为计算随后的每个研究周。每项研究的数据分别进行分析，并按安慰剂组和联合索里亚非托组进行总结。

 结果：

常见的早发性 TEAE（剂量≤150 mg，即批准剂量）包括头痛（OSA，5.1%；发作性睡病，8.5%）、恶心（OSA，2.5%；发作性睡病，4.2%）、食欲下降（OSA，4.2） %；发作性睡病，5.9%），以及 OSA 中的焦虑（2.1%）、失眠（1.3%）和紧张感（3.0%）以及发作性睡病中的口干（4.2%）。常见早发性 TEAE 的发生率在第 1 周最高，并随着时间的推移而下降。在剂量≤150 mg的OSA中，头痛、恶心和紧张的中位持续时间≤8天，而食欲下降、焦虑和失眠的持续时间较长。在剂量≤150 mg的发作性睡病中，头痛和恶心的中位持续时间≤8天，而食欲下降和口干的持续时间较长。大多数 TEAE 的严重程度为轻度至中度。

 结论：

solriamfetol 引起的常见早发 TEAE 持续时间有限，大多数在治疗第一周内消退。

临床试验注册：

 NCT02348593； NCT02348606