- A meta-analysis finds that solriamfetol, which was approved by the FDA and EMA in 2019, is safe and effective for excessive daytime sleepiness specifically in narcolepsy and obstructive sleep apnea (OSA).
Why this matters
- The results offer estimates of solriamfetol's efficacy and safety, which clinicians may use in decision-making.
- Meta-analysis of 8 articles reported from 5 clinical trials (n>1000).
- Primary outcomes were mean difference in the maintenance of wakefulness test (MWT), Epworth sleepiness scale (ESS) score, and risk ratio for adverse events.
- Funding: None disclosed.
- The MWT showed a mean increase of 9.93 (95% CI, 8.25-11.61) minutes, favoring solriamfetol over placebo.
- Solriamfetol vs placebo showed a mean improvement in the ESS score of −4.44 (95% CI, −5.50 to −3.38).
- Solriamfetol vs placebo was associated with almost 50% more adverse events (risk ratio, 1.47; 95% CI, 1.28-1.69).
- The most frequent adverse events were headache, nausea, decreased appetite, anxiety, nasopharyngitis, and insomnia, most of which were minor.
- Small number of trials and small sample sizes.