Calcium, magnesium, potassium, and sodium oxybates

(Xywav®)

Calcium, magnesium, potassium, and sodium oxybates

Drug updated on 5/17/2024

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.

Summary
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  • 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.