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sodium oxybate

Adjunctive therapy

Brands: Xyrem

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is sodium oxybate?

    Sodium oxybate (brand Xyrem) is a nighttime medication indicated for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy (label).

  • What is Xyrem?

    Xyrem is a brand name for sodium oxybate.

  • What is Xyrem (sodium oxybate) used for?

    Label indications include: Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy; REMS-restricted (label).

  • What drug class is Xyrem (sodium oxybate)?

    Nighttime CNS depressant (sodium oxybate; oxybate/GHB) indicated for cataplexy and excessive daytime sleepiness in narcolepsy (patients 7+); Schedule III with boxed warning for CNS depression and abuse/misuse, and dispensed under a REMS due to risk of respiratory depression and misuse.

  • What strengths does Xyrem (sodium oxybate) come in?

    Oral solution: 0.5 g/mL (label).

Snapshot

  • Class: Adjunctive therapy
  • Common US brands: Xyrem
  • Therapeutic drug monitoring not routinely recommended.
  • Last reviewed: 2025-12-30

Label indications

Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy; REMS-restricted (label).

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Clinical Highlights

Sodium oxybate (brand Xyrem) is a nighttime medication indicated for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy (label). It is a CNS depressant and a Schedule III controlled substance. It has a boxed warning for CNS depression and abuse/misuse and is dispensed only through a REMS due to risk of respiratory depression and misuse (label).

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  • Practical use requires nightly planning: dosing is split into two doses (bedtime and 2.5 to 4 hours later), and many patients fall asleep quickly after dosing; fall risk and safe storage are common counseling priorities (label/clinical).
  • Alcohol and other sedatives increase risk of respiratory depression and are generally avoided; interaction review is especially important in polypharmacy and in patients with substance use risk (label/clinical).
  • The compare view, sodium oxybate evidence feed, and sodium oxybate print page help compare wake-promoting approaches and implementation constraints.

Dosing & Formulations

Oral solution concentration: 0.5 g/mL; dosing is prescribed in grams per night and split into two doses (label). Adults: start 4.5 g per night (2.25 g at bedtime and 2.25 g 2.5 to 4 hours later). Titrate by 1.5 g per night at weekly intervals to an effective range of 6–9 g per night; doses above 9 g have not been studied and are not ordinarily administered (label).

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  • Food reduces absorption; the first dose is taken at least 2 hours after eating (label).
  • Both doses are prepared before bedtime and each dose is diluted with water in pharmacy-provided containers; the second dose is taken 2.5 to 4 hours after the first (label).

Monitoring & Risks

CNS and respiratory depression risk is the core safety concern; risk is higher with sedatives, alcohol, or underlying respiratory compromise (label/clinical). Sudden sleep onset after dosing can lead to falls and injuries; safe nighttime environment planning is clinically important (label/clinical).

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  • Misuse/diversion risk is addressed through REMS enrollment, safe storage, and clinical monitoring, particularly in patients with substance use disorders (label/clinical).
  • Hepatic impairment prolongs half-life and increases exposure; lower starting doses are used and monitoring is emphasized (label).

Drug Interactions

Alcohol and sedative-hypnotics are generally avoided due to additive CNS depression and respiratory depression risk (label). Concomitant divalproex/valproate increases oxybate exposure; an initial dose reduction of at least 20% is recommended with close monitoring (label).

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  • Other CNS depressants (benzodiazepines, opioids, some antipsychotics, sedating antidepressants) can increase sedation and respiratory risk; careful review is a routine safety step (label/clinical).

Practice Notes

Implementation is often the limiting factor: split-night dosing, safe storage, and avoidance of alcohol/sedatives require structured counseling and follow-up (clinical). In serious mental illness, clinicians often coordinate dosing plans with sleep timing, housing stability, and co-medications to reduce fall risk and ensure adherence (clinical).

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  • When insomnia or nocturnal confusion worsens, reassessment of dosing, timing, and interacting sedatives is often prioritized before adding additional hypnotics (clinical).

References

  1. XYREM (sodium oxybate) oral solution prescribing information — DailyMed (2025)
  2. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline — Journal of Clinical Sleep Medicine (2021)
  3. Treatment OF Central Disorders OF Hypersomnolence: AN American Academy OF Sleep Medicine Systematic Review, Meta Analysis, AND Grade Assessment — Journal of Clinical Sleep Medicine (2021)
  4. Sodium oxybate improves excessive daytime sleepiness in narcolepsy — Sleep (2006)
Sodium oxybate (Xyrem) — Summary — PsychMed