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 treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
- Indicated for treatment of idiopathic hypersomnia (IH) in adults.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Solriamfetol showed greater efficacy in reducing excessive daytime sleepiness (EDS) compared to pitolisant and sodium oxybate, with superior outcomes on the Epworth Sleepiness Scale (ESS) (mean difference (MD) -2.88, 95% confidence interval (CI) -4.89 to -0.88 compared to pitolisant; MD -2.56, 95% CI -4.62 to -0.51 compared to sodium oxybate) and the Maintenance of Wakefulness Test (MWT) (standardized mean differences (SMD) 0.45, 95% CI 0.02 to 0.88 compared to pitolisant; SMD 0.42, 95% CI 0.05 to 0.79 compared to modafinil).
- Sodium oxybate significantly reduced narcolepsy-related symptoms, including cataplexy attacks (P = 0.001), subjective daytime sleepiness (P < 0.0001), sleep latency (P < 0.0001), inadvertent naps/sleep attacks (P < 0.00001), and improved sleep architecture with notable changes in stage 1 sleep (P = 0.04), slow wave sleep (P = 0.003), rapid eye movement (REM) sleep (P = 0.0006), nocturnal awakenings (P = 0.004), and overall quality of nocturnal sleep (P < 0.00001).
- Clinical gamma hydroxybutyrate (GHB) use is not associated with cognitive impairments, while recreational GHB use at moderate levels may result in short-term cognitive impairments, and regular high-dose use or GHB-induced comas are likely linked to long-term cognitive impairments and neurotoxicity.
- GHB demonstrated lower tolerability compared to placebo due to dose-dependent side effects (relative risk (RR) = 6.08; 95% CI = 2.18 to 16.97; P = 0.0006).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xywav (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 |
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 |