Drug updated on 9/4/2024
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
- Xywav (calcium, magnesium, potassium, and sodium oxybates) is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia (IH) in adults.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Obstructive Sleep Apnea (OSA): Sodium oxybate significantly reduced the Apnea-Hypopnea Index (AHI) with a mean difference of -5.50 (95% CI: -9.28, -1.73; p = 0.004) compared to placebo.
- Narcolepsy (Excessive Daytime Sleepiness - EDS): Sodium oxybate improved Epworth Sleepiness Scale (ESS) scores but was less effective than solriamfetol (MD -2.56, 95% CI -4.62, -0.51). Gamma-Hydroxybutyrate (GHB), which includes sodium oxybate, significantly improved narcolepsy-related symptoms and polysomnographic measures.
- The meta-analysis found that GHB (including sodium oxybate) was less well tolerated than placebo, with a relative risk (RR) of 6.08 (95% CI: 2.18 to 16.97; p = 0.0006) for dose-dependent adverse events.
- Adults with Narcolepsy: The meta-analysis concentrated on adults with narcolepsy, finding that GHB was effective in improving narcolepsy-cataplexy and related symptoms but was associated with dose-dependent side effects, reducing its tolerability compared to placebo in this population.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xywav (calcium, magnesium, potassium, and sodium oxybates) Prescribing Information. | 2023 | Jazz Pharmaceuticals, Inc., Palo Alto, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Pharmacological treatment for obstructive sleep apnea: a systematic review and meta-analysis. | 2024 | Clinics |
Pharmacological interventions for excessive daytime sleepiness in adults with narcolepsy: a systematic review and network meta-analysis. | 2022 | Journal of Clinical Medicine |
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 |
European guideline and expert statements on the management of narcolepsy in adults and children. | 2021 | European Journal of Neurology |