Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 75 mg, 150 mg) |
Drug Class | Dopamine 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).
Latest News
Summary
- 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% confidence interval (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 RR of 1.42 (95% CI: 1.24 to 1.64, P < 0.00001).
- For OSA patients, pharmacotherapy with solriamfetol significantly alleviated EDS without a significant increase in serious adverse events when compared to placebo, indicating a generally favorable safety profile.
- Solriamfetol demonstrated efficacy in reducing EDS in patients with narcolepsy, effective in both those with and without cataplexy, indicating its relevance for a broad patient population. In OSA patients, pharmacotherapy, including solriamfetol, significantly alleviated EDS, supporting its use in this condition as well.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Sunosi (solriamfetol) Prescribing Information. | 2023 | Axsome Therapeutics Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline | 2021 | Journal of Clinical Sleep Medicine |
European guideline and expert statements on the management of narcolepsy in adults and children | 2021 | Journal of Sleep Research |