Oxybate

(Xywav®)

Oxybate

Drug updated on 11/5/2024

Dosage FormSolution (oral; 0.5 g/mL)
Drug ClassCentral 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.

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Summary
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  • 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) (MD (mean difference) -2.88, 95% CI (confidence interval) -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) (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), REM sleep (P = 0.0006), nocturnal awakenings (P = 0.004), and overall quality of nocturnal sleep (P < 0.00001).
  • Clinical 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 (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 TitleYearSource
Xywav (oxybate) Prescribing Information.2023Jazz Pharmaceuticals, Inc., Palo Alto, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline2021Journal of Clinical Sleep Medicine : Jcsm : Official Publication of the American
European guideline and expert statements on the management of narcolepsy in adults and children2021European Journal of Neurology