Solriamfetol

(Sunosi®)

Solriamfetol

Drug updated on 4/18/2024

Dosage FormTablet (oral; 75 mg, 150 mg)
Drug ClassDopamine 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).

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines