Drug updated on 5/17/2024
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
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Summary
- Calcium, magnesium, potassium, and sodium oxybates (Xywav) is indicated for treating cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. It is also used to treat idiopathic hypersomnia in adults.
- Three systematic reviews/meta-analyses provided insights into Xywav's efficacy, safety profile, and comparison with other drugs for treating narcolepsy-related symptoms.
- The sodium oxybate component of Xywav demonstrated a reduction in the Apnea-Hypopnea Index compared to placebo, indicating its potential use against obstructive sleep apnea; however, it showed a smaller effect size than treatments with atomoxetine plus oxybutynin, donepezil, and trazodone.
- In terms of managing excessive daytime sleepiness associated with narcolepsy, solriamfetol was found superior, but when considering both efficacy and safety profiles together, sodium oxybate along with pitolisant & modafinil offered more balanced outcomes, suggesting that treatment choice should be guided by patient context.
- Gamma-hydroxybutyrate (GHB), another form included within Xywav, effectively improved various symptoms related to narcolepsy-cataplexy, including subjective daytime sleepiness, but presented dose-dependent side effects, making it less well-tolerated than placebo. This emphasizes the need for balancing effectiveness against potential side effects.
- While these studies largely focused on adult populations, the indication includes usage among patients aged 7 years or above, highlighting the need for further research, especially long-term studies, across diverse population groups.
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 |