Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 75 mg, 150 mg) |
Drug Class | Dopamine and norepinephrine reuptake inhibitors |
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
- Sunosi (solriamfetol) is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Solriamfetol significantly improved Epworth Sleepiness Scale (ESS) scores in patients with Obstructive Sleep Apnea (OSA) compared to placebo (MD -3.85, 95% CI -5.24 to -2.50) with high certainty of evidence, and also ranked highest in improving ESS and Maintenance of Wakefulness Test (MWT) outcomes in patients with narcolepsy when compared to pitolisant, modafinil, and sodium oxybate.
- Armodafinil-modafinil showed moderate to high certainty in improving ESS scores (MD -2.25, 95% CI -2.85 to -1.64) and MWT outcomes (SMD 0.41, 95% CI 0.27 to 0.55) in OSA patients, while pitolisant-H3-autoreceptor blockers showed moderate efficacy in improving ESS scores (MD -2.78, 95% CI -4.03 to -1.51) and probable ineffectiveness in improving MWT.
- Solriamfetol demonstrated a consistent safety profile across studies, showing an increased risk of adverse events (RR 1.42, 95% CI 1.24 to 1.64) in narcolepsy patients without a significant increase in serious adverse events, with similar safety risks observed for solriamfetol, modafinil, and armodafinil in both OSA and narcolepsy.
- Solriamfetol may increase the risk for discontinuation due to adverse events in OSA patients (RR, 2.07 [CI, 0.67 to 6.25]; low certainty) and demonstrated an increased risk of adverse events in narcolepsy patients (RR = 1.42, 95% CI: 1.24 to 1.64), though there was no significant increase in serious adverse events.
- Armodafinil-modafinil probably increases the risk for discontinuation due to adverse events in OSA patients (RR, 2.01 [CI, 1.14 to 3.51]; moderate certainty), with low certainty evidence suggesting that these interventions may not increase the risk for serious adverse events.
- There is no population types or subgroups information available in the reviewed studies.
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 |
---|---|---|
European guideline and expert statements on the management of narcolepsy in adults and children. | 2021 | Journal of Sleep Research |
Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. | 2021 | Journal of Clinical Sleep Medicine |
Pharmacologic treatment of sleep disorders. | 2020 | Premera Blue Cross |