Drug updated on 12/11/2024
Dosage Form | Solution (oral; 0.5 g/ml) |
Drug Class | Central nervous system depressants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
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Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Epworth Sleepiness Scale (ESS) Improvements: Solriamfetol demonstrated greater efficacy in reducing ESS scores than sodium oxybate (mean difference (MD) -2.56, 95% confidence interval (CI) -4.62 to -0.51) and pitolisant (MD -2.88, 95% CI -4.89 to -0.88).
- Maintenance of Wakefulness Test (MWT) Improvements: Solriamfetol showed a superior effect on MWT compared to pitolisant (standardized mean difference (SMD) 0.45, 95% CI 0.02 to 0.88) and modafinil (SMD 0.42, 95% CI 0.05 to 0.79).
- Narcolepsy Symptoms and Sleep Metrics: Sodium oxybate improved multiple narcolepsy symptoms, including cataplexy, daytime sleepiness, sleep latency, sleep stages, nocturnal awakenings, and quality of life, with no observed effect on stage 2 sleep (P = 0.88).
- Sodium Oxybate: Associated with dose-dependent adverse effects and is less well tolerated than placebo (relative risk (RR) = 6.08; 95% CI = 2.18 to 16.97; P = 0.0006). No cognitive impairments observed in clinical use; however, moderate recreational use can lead to acute cognitive impairments, and high-dose or multiple gamma-hydroxybutyrate acid (GHB)-induced comas may result in long-term cognitive impairments. High dependence potential and possible neurotoxic effects at elevated doses.
- Comparative Safety: While solriamfetol demonstrated superior efficacy, the overall efficacy-safety balance for sodium oxybate, pitolisant, and modafinil was more favorable than for solriamfetol.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xyrem (sodium oxybate) Prescribing Information. | 2023 | Jazz Pharmaceuticals, Inc., Palo Alto, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Pharmacological Interventions for Excessive Daytime Sleepiness in Adults with Narcolepsy: A Systematic Review and Network Meta-Analysis | 2022 | Journal of Clinical Medicine |
Cognitive Impairment Following Clinical or Recreational Use of Gammahydroxybutyric Acid (GHB): A Systematic Review | 2022 | Current Neuropharmacology |
Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment | 2021 | Journal of Clinical Sleep Medicine : Jcsm : Official Publication of the American |
Gamma-hydroxybutyrate (GHB) for narcolepsy in adults: an updated systematic review and meta-analysis | 2019 | Sleep Medicine |
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 : Jcsm : Official Publication of the American |
European guideline and expert statements on the management of narcolepsy in adults and children | 2021 | European Journal of Neurology |