Solriamfetol

(Sunosi®)

Sunosi®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 75 mg, 150 mg)
Drug ClassDopamine and norepinephrine reuptake inhibitors (DNRI)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Solriamfetol demonstrates significant effectiveness in reducing excessive daytime sleepiness (EDS) in patients with narcolepsy, showing improvements in the Epworth Sleepiness Scale (ESS) score with a mean difference (MD) of -2.88 (95% CI: -4.89 to -0.88) compared to pitolisant, and an MD of -2.56 (95% CI: -4.62 to -0.51) compared to sodium oxybate. Similar improvements were observed in obstructive sleep apnea (OSA) patients, highlighting solriamfetol's efficacy across both conditions.
  • In individuals with narcolepsy, solriamfetol was effective regardless of cataplexy status, while pharmacotherapy for OSA consistently improved ESS and Maintenance of Wakefulness Test (MWT) scores, indicating its relevance for various patient populations experiencing EDS.
  • The safety profile of solriamfetol shows a higher incidence of adverse events, particularly in the narcolepsy population (Risk Ratio [RR] = 1.42, 95% CI: 1.24 to 1.64, P < 0.00001), necessitating careful consideration of individual patient factors when selecting treatment options.
  • In patients with narcolepsy, solriamfetol showed a higher risk of adverse events compared to pitolisant, sodium oxybate, and modafinil, with common adverse events including headache, nausea, decreased appetite, anxiety, nasopharyngitis, and insomnia. The increased risk of adverse events was quantified with a risk ratio (RR) of 1.42 (95% CI: 1.24 to 1.64, P < 0.00001).
  • For obstructive sleep apnea (OSA) patients, pharmacotherapy with solriamfetol significantly alleviated excessive daytime sleepiness (EDS) without a significant increase in serious adverse events when compared to placebo, indicating a generally favorable safety profile.
  • Solriamfetol demonstrated efficacy in reducing excessive daytime sleepiness (EDS) in patients with narcolepsy, effective in both those with and without cataplexy, indicating its relevance for a broad patient population. In obstructive sleep apnea (OSA) patients, pharmacotherapy, including solriamfetol, significantly alleviated EDS, supporting its use in this condition as well.

Product Monograph / Prescribing Information

Document TitleYearSource
Sunosi (solriamfetol) Prescribing Information.2023Axsome Therapeutics Inc., New York, NY

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines