sodium oxybate extended-release
Brands: Lumryz
Last reviewed 2025-12-30
Reviewed by PsychMed Editorial Team.
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).
View labelExactClinical 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
- Lumryz (sodium Oxybate) FOR Extended Release Oral Suspension Prescribing Information — DailyMed (2025)
- Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline — Journal of Clinical Sleep Medicine (2021)
- 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)
- Once Nightly Sodium Oxybate (ft218) Demonstrated Improvement OF Symptoms IN A Phase 3 Randomized Clinical Trial IN Patients With Narcolepsy — Sleep (2021)
