Drug updated on 4/18/2024
| 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).
Summary
- Solriamfetol (Sunosi) is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. It acts as a selective norepinephrine-dopamine reuptake inhibitor and has been substantiated by its capability to enhance wakefulness, as measured by the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test.
- Seven systematic reviews/meta-analyses were examined, focusing on studies involving Sunosi (solriamfetol) for the management of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
- Solriamfetol was found to be more effective than other pharmacological agents such as armodafinil-modafinil and pitolisant-H3-autoreceptor blockers in certain situations. For patients receiving conventional management for OSA, it demonstrated improvement over placebo in ESS scores and MWT outcomes.
- Among patients with narcolepsy, solriamfetol showed superior efficacy in reducing excessive daytime sleepiness compared to pitolisant, sodium oxybate, and modafinil. Nevertheless, these alternatives might provide more balanced safety-efficacy profiles compared to solriamfetol.
- The risk of discontinuation due to adverse events was greater among those treated with armodafinil-modafinil, but this risk was also a consideration for those taking solriamfetol, albeit at lower certainty levels. Common side effects included headache, nausea, decreased appetite, anxiety, nasopharyngitis, and insomnia; the overall risk being higher than that of placebo without a significant increase in serious adverse events.
- Evidence regarding the long-term efficacy or effectiveness among nonadherent patients or those with mixed adherence to conventional OSA therapies is limited, indicating a need for further research across diverse patient groups. No specific subgroup considerations beyond the general adult population with narcolepsy or OSA were identified in the studies reviewed.
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 |