Study Finds Solriamfetol Effective, Safe as Treatment of Excessive Daytime Sleepiness

Solriamfetol was found to be efficacious and safe in the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy and obstructive sleep apnea (OSA), according to study findings published in Sleep Medicine.

As researchers highlight, EDS is characterized by the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times. In determining risk of EDS, OSA have been noted as the most commonly encountered cause of the condition. Moreover, EDS serves as an essential symptom of narcolepsy, and is typically the first symptom that people notice.

In addressing therapies approved to treat EDS, researchers spotlighted solriamfetol, a selective norepinephrine-dopamine reuptake inhibitor, as a potentially effective medication. As the first dual-acting dopamine and norepinephrine reuptake inhibitor, solriamfetol is indicated for patients suffering from fatigue due to narcolepsy or OSA. However, it is not intended to treat the underlying airway obstruction in OSA, with continuous airway pressure therapy recommended for at least 1 month prior to use.

Researchers sought to further examine solriamfetol in patients with EDS in narcolepsy or OSA. They conducted a systematic search of the electronic database for relevant randomized controlled trials with outcome measures on the efficacy or safety of solriamfetol in EDS.

Primary outcomes assessed included mean difference in the maintenance of wakefulness test (MWT), Epworth sleepiness scale (ESS) score, and risk ratio of adverse events, with a random-effects model used to calculate the pooled effect estimates. In conducting the database search, 336 records were identified, in which 8 articles from 6 clinical trials were analyzed. Researchers pooled outcome measures from 5 trials.

In their findings, researchers identified an overall mean difference for MWT (9.93 min; 95% CI, 8.25–11.61) and mean difference of ESS scores (–4.44; 95% CI, –5.5 to –3.38) that were both in favor of solriamfetol over placebo. Additionally, the overall risk ratio of adverse events with solriamfetol was 1.47 (95% CI, 1.28–1.69), indicating an increased risk among those taking the medication. Although, the most common adverse effects listed were minor, note researchers, which included headache, nausea, decreased appetite, anxiety, nasopharyngitis, and insomnia.

“Solriamfetol is efficacious and has a favorable safety profile in the treatment of EDS in patients with narcolepsy and OSA,” conclude researchers. “Solriamfetol is well tolerated and may be recommended for the treatment of EDS in these patients.”

Reference

Subedi R, Singh R, Thakur RK, Bibek KC, Jha D, Ray BK. Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. Sleep Med. Published online September 21, 2020. doi:10.1016/j.sleep.2020.09.019