Sodium oxybate

(Xyrem®)

Sodium oxybate

Drug updated on 11/4/2024

Dosage FormSolution (oral; 0.5 g/ml)
Drug ClassCentral 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
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  • 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 (MD (mean difference) -2.56, 95% CI (confidence interval) -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 (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 (RR (relative risk) = 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 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 TitleYearSource
Xyrem (sodium 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