Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials

Abstract

Background: Solriamfetol is developed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA). No systematic review of existing literature has been investigated before. Therefore, the meta-analysis is conducted to assess the efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and OSA.

Methods: PubMed, Embase and Cochrane Library databases were searched from earliest date to July 2020 for randomized controlled trials (RCTs) and the primary outcomes were change from baseline in mean sleep latency and Epworth Sleepiness Scale (ESS).

Results: We pooled 1177 patients from five RCTs and found solriamfetol led to a significant increment in mean sleep latency (MD = 9.52, 95% CI: 7.60 to 11.44, P < 0.00001) and a reduction in ESS score (MD = -3.74, 95% CI: -4.38 to -3.09, P < 0.00001) compared with placebo. The proportion of patients with at least one adverse event was significantly increased in solriamfetol group (RR = 1.42, 95% CI: 1.24 to 1.64, P < 0.00001), while no statistical differences existed in the risk of at least one serious adverse event between solriamfetol and controlled group (RR = 0.95, 95% CI: 0.24 to 3.77, P = 0.39).

Conclusions: A dose of 150 mg solriamfetol is proved to be the appropriate and stable dose for excessive sleepiness. In addition, solriamfetol showed good efficacy for excessive sleepiness in narcolepsy and OSA but also significantly increases the risk of adverse events.

Keywords: Excessive sleepiness; Meta-analysis; Narcolepsy; Obstructive sleep apnea; Solriamfetol.