Abad Vivien C
Department of Psychiatry & Behavioral Sciences, Division of Sleep Medicine, Stanford University, Redwood City, CA 94063, USA.
Nat Sci Sleep. 2021 Jan 25;13:75-91. doi: 10.2147/NSS.S245020. eCollection 2021.
Excessive sleepiness (ES) is a symptom of obstructive sleep apnea (OSA) and narcolepsy that has severe consequences. Wake-promoting drugs and stimulants are utilized as accessory treatment in OSA to reduce propensity to sleep but they do not improve sleep-disordered breathing. Solriamfetol is a first-line therapeutic agent to combat sleepiness in OSA and narcolepsy patients that is approved both by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For excessively sleepy adult patients with OSA despite primary treatment or narcolepsy patients without cataplexy, solriamfetol may be used as initial therapy or as replacement therapy in patients who fail treatment or experience unacceptable side effects with modafinil, armodafinil, pitolisant, or stimulants. It can also be used as add-on therapy in OSA or narcolepsy patients when ES is only partially controlled with modafinil, armodafinil, pitolisant, sodium oxybate, or stimulants. Solriamfetol is a phenylalanine derivative whose wake-promoting action may be mediated through its selective dopamine and norepinephrine reuptake inhibition. This paper reviews the profile of solriamfetol in treating ES associated with OSA or narcolepsy and discusses patient selection and clinical perspectives. Mechanism of action, pharmacology, pharmacokinetics, clinical efficacy, and tolerability of solriamfetol are described. The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) solriamfetol trials demonstrated the efficacy of solriamfetol in reducing propensity to sleep and maintaining wakefulness, with significant improvements in mean maintenance of wakefulness test (MWT) sleep latencies and significant reduction in Epworth Sleepiness Scale (ESS) scores compared to placebo. With solriamfetol, significantly higher percentages of patients showed improvement in patient's and clinician's global impression of change.
过度嗜睡(ES)是阻塞性睡眠呼吸暂停(OSA)和发作性睡病的一种症状,会产生严重后果。促醒药物和兴奋剂在OSA中用作辅助治疗,以降低嗜睡倾向,但它们并不能改善睡眠呼吸紊乱。索利那非是治疗OSA和发作性睡病患者嗜睡的一线治疗药物,已获得美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)的批准。对于尽管接受了初步治疗但仍过度嗜睡的成年OSA患者或无猝倒的发作性睡病患者,索利那非可作为初始治疗药物,或用于对莫达非尼、阿莫达非尼、匹托利生或兴奋剂治疗无效或出现不可接受副作用的患者的替代治疗。当ES仅通过莫达非尼、阿莫达非尼、匹托利生、羟丁酸钠或兴奋剂得到部分控制时,它也可作为OSA或发作性睡病患者的附加治疗药物。索利那非是一种苯丙氨酸衍生物,其促醒作用可能通过选择性抑制多巴胺和去甲肾上腺素再摄取来介导。本文综述了索利那非治疗与OSA或发作性睡病相关的ES的概况,并讨论了患者选择和临床前景。描述了索利那非的作用机制、药理学、药代动力学、临床疗效和耐受性。OSA和发作性睡病过度嗜睡治疗(TONES)索利那非试验证明了索利那非在降低嗜睡倾向和维持清醒方面的疗效,与安慰剂相比,平均清醒维持试验(MWT)睡眠潜伏期有显著改善,爱泼华嗜睡量表(ESS)评分显著降低。使用索利那非时,患者和临床医生对变化的总体印象有显著更高比例的患者得到改善。