Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials.

INTRODUCTION

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.