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sodium oxybate extended-release

Adjunctive therapy

Brands: Lumryz

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is sodium oxybate extended-release?

    Sodium oxybate extended-release (brand Lumryz) is a once-nightly oxybate product indicated for Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy (label).

  • What is Lumryz?

    Lumryz is a brand name for sodium oxybate extended-release.

  • What is Lumryz (sodium oxybate extended-release) 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 Lumryz (sodium oxybate extended-release)?

    Nighttime CNS depressant (sodium oxybate; oxybate/GHB) once-nightly extended-release oral suspension indicated for cataplexy or excessive daytime sleepiness in narcolepsy (patients 7+); Schedule III with boxed warning for respiratory depression and abuse/misuse and dispensed under a REMS. Alcohol is contraindicated due to dose-dumping risk (label).

  • What strengths does Lumryz (sodium oxybate extended-release) come in?

    Extended-release oral suspension powder packets: 4.5 g, 6 g, 7.5 g, and 9 g (label).

Snapshot

  • Class: Adjunctive therapy
  • Common US brands: Lumryz
  • 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 extended-release (brand Lumryz) is a once-nightly oxybate product indicated for Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy (label). Like other oxybate products, it is a CNS depressant and a Schedule III controlled substance with a boxed warning for CNS/respiratory depression and abuse/misuse; it is dispensed only through a REMS due to risk of respiratory depression and misuse (label).

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  • The clinical differentiator is dosing convenience: Lumryz is dosed once per night, avoiding a middle-of-the-night second dose that immediate-release sodium oxybate products require. This can reduce sleep disruption and adherence burden for some patients (label/clinical).
  • Safety counseling remains intensive: rapid sedation, falls/injuries, safe storage, and strict avoidance of alcohol and other CNS depressants are core topics (label/clinical).
  • Alcohol is contraindicated. The extended-release formulation has an alcohol-associated dose-dumping signal that can increase early drug release and respiratory risk (label).
  • The compare view, Lumryz evidence feed, and print page help compare oxybate formulations and non-oxybate alternatives.

Dosing & Formulations

Extended-release oral suspension powder packets: 4.5 g, 6 g, 7.5 g, and 9 g (label). Adults: start 4.5 g once per night; increase by 1.5 g per night at weekly intervals to the recommended range of 6–9 g once nightly (label).

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  • Patients on immediate-release sodium oxybate can be switched to Lumryz at the nearest equivalent total nightly dose in grams (label).
  • Food reduces absorption; dosing is separated from meals (label).
  • The powder is mixed with water before administration. Patients are typically counseled to take the dose while in bed due to rapid sedation (label/clinical).

Monitoring & Risks

CNS and respiratory depression risk is the central safety concern; risk increases with sedatives, alcohol, or underlying respiratory compromise (label/clinical). Misuse/diversion risk is addressed through REMS enrollment, safe storage, and monitoring, especially when there is substance use risk (label/clinical).

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  • Lumryz contains sodium; overall sodium burden can matter when patients have hypertension, heart failure, kidney disease, or other cardiovascular risk factors (label/clinical).
  • Hepatic impairment increases exposure. The label recommends against initiating Lumryz in patients with hepatic impairment; reassess risk when liver function changes (label).

Drug Interactions

Alcohol is contraindicated. Sedative-hypnotics and other CNS depressants are generally avoided due to additive sedation and respiratory depression risk (label). Divalproex/valproate produces a modest exposure increase; sedating pharmacodynamic interactions are still a concern, so monitoring is emphasized when co-prescribed (label/clinical).

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  • Opioids, benzodiazepines, sedating antidepressants, and some antipsychotics can increase impairment and respiratory risk; careful review of total sedative burden is a routine safety step (label/clinical).

Practice Notes

Once-nightly dosing can improve feasibility, but REMS requirements and strict avoidance of alcohol/sedatives still drive patient selection and follow-up structure (clinical). When obstructive sleep apnea is untreated or opioids are required, clinicians often reassess whether an oxybate product is appropriate due to respiratory risk (clinical).

References

  1. Lumryz (sodium Oxybate) FOR Extended Release Oral Suspension 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. Once Nightly Sodium Oxybate (ft218) Demonstrated Improvement OF Symptoms IN A Phase 3 Randomized Clinical Trial IN Patients With Narcolepsy — Sleep (2021)
Sodium oxybate extended-release (Lumryz) — Summary — PsychMed