University of Florida Colleges of Pharmacy and Medicine, Gainesville, FL, USA.
Florida State University College of Medicine, Tallahassee, FL, USA.
Ann Pharmacother. 2020 Oct;54(10):1016-1020. doi: 10.1177/1060028020915537. Epub 2020 Apr 9.
The purpose of this article is to review the available clinical trial data that led to the Food and Drug Administration (FDA) approval of solriamfetol as well as its role in clinical practice.
A MEDLINE/PubMed search was conducted (January 2000 to February 2020) using the keyword to discover appropriate clinical trials.
Articles were included that were published in the English language and related to the FDA approval of solriamfetol or provided novel information regarding this drug entity.
The findings of the review show that solriamfetol may be a safe and effective option for the treatment of excessive sleepiness (ES) related to narcolepsy and obstructive sleep apnea (OSA).
Solriamfetol is distinguished from other stimulants in that it has lower binding affinity to dopamine and norepinephrine transporters and does not have the monoamine-releasing effects of amphetamines at usual therapeutic doses. Because of solriamfetol's unique mechanism of action, there may be a reduction in abuse potential compared with the other currently FDA-approved options.
In clinical trials, solriamfetol has shown dose-dependent improvement in wakefulness over placebo and adds another option for clinicians when treating ES in narcolepsy and OSA.
本文旨在回顾导致 FDA 批准索里昂(solriamfetol)的现有临床试验数据,以及其在临床实践中的作用。
使用关键词 进行了 MEDLINE/PubMed 搜索(2000 年 1 月至 2020 年 2 月),以发现合适的临床试验。
纳入了以英文发表且与 FDA 批准索里昂或提供有关该药物实体的新信息相关的文章。
综述结果表明,索里昂可能是治疗与发作性睡病和阻塞性睡眠呼吸暂停(OSA)相关的过度嗜睡(ES)的安全有效的选择。
与其他兴奋剂相比,索里昂对多巴胺和去甲肾上腺素转运体的结合亲和力较低,且在常规治疗剂量下没有安非他命的单胺释放作用。由于索里昂的独特作用机制,与其他目前 FDA 批准的选择相比,其滥用潜力可能降低。
在临床试验中,索里昂显示出剂量依赖性的清醒改善,优于安慰剂,为治疗发作性睡病和 OSA 中的 ES 提供了另一种选择。