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sodium oxybate extended-release

Adjunctive therapy

Brand: Lumryz

Published 2026-02-15 · Last reviewed 2026-02-22 · 4 references

Content sourced from FDA labeling (DailyMed) and peer-reviewed literature.

Print sheet Review evidence

At a glance

Class: Adjunctive therapy·Typical dose: Adults: start 4.5 g once per night. Increase by 1.5 g per night at weekly intervals to a recommended range of 6–9 g once nightly; doses higher than 9 g per night have not been studied and should not ordinarily be administered (label).·Half-life: Single-dose range 0.5–1 h·LAI available: No

Class: Adjunctive therapy
Typical dose: Adults: start 4.5 g once per night. Increase by 1.5 g per night at weekly intervals to a recommended range of 6–9 g once nightly; doses higher than 9 g per night have not been studied and should not ordinarily be administered (label).
Half-life: Single-dose range 0.5–1 h
LAI available: No

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)?: Oxybate (Narcolepsy).
What is the mechanism of action of 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).

General information

Sodium oxybate extended-release (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).

It contains sodium oxybate (oxybate/GHB), a CNS depressant and 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).

The key practical differentiator is dosing: Lumryz is once nightly, so it can avoid a planned middle-of-the-night second dose required by immediate-release sodium oxybate. This can reduce sleep disruption and adherence burden for some patients (label/clinical).

Alcohol is contraindicated. The extended-release formulation has an alcohol-associated dose-dumping signal that can increase early drug release and raise respiratory risk (label).

The Lumryz compare view, evidence feed, and print page support review of oxybate formulations and alternatives.

U.S. approvals

Cataplexy in narcolepsy (patients 7 years and older) (2023)
Excessive daytime sleepiness in narcolepsy (patients 7 years and older) (2023)

Formulations & strengths

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

Generic availability

Not available generically (brand-only under REMS).

Once-nightly dosing can improve feasibility versus split-night oxybate, but REMS requirements, strict avoidance of alcohol/sedatives, and safe storage remain central implementation constraints. Sodium burden can also matter for patients with hypertension, heart failure, or kidney disease (label/clinical).

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Mechanism of action

Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.

Oxybate (GHB) is a CNS depressant. Clinical framing emphasizes nighttime consolidation of sleep and downstream improvements in cataplexy and EDS when titrated to an effective dose (label/clinical).

Because sedation can occur quickly after dosing, safety planning prioritizes taking the dose while in bed and avoiding hazardous activities after dosing (label/clinical).

CNS depressant (oxybate/GHB; mechanism related to sleep consolidation).

Metabolism & pharmacokinetics

Clearance is almost entirely by biotransformation to carbon dioxide, which is eliminated by expiration; <5% of unchanged drug appears in urine within 6 to 8 hours after dosing (label).
Elimination half-life is ~0.5–1 hour; hepatic impairment prolongs half-life and increases exposure (label).
Food reduces absorption; dosing is separated from meals (label).

Dosing & administration

Adults: start 4.5 g once per night. Increase by 1.5 g per night at weekly intervals to a recommended range of 6–9 g once nightly; doses higher than 9 g per night have not been studied and should not ordinarily be administered (label).
Pediatric patients 7 years and older: dosing is weight-based with maximum total nightly doses by weight band (label).
Patients treated with immediate-release sodium oxybate can be switched to Lumryz at the nearest equivalent total nightly dose in grams (label).
Mix the packet with water before administration; take the dose while in bed due to rapid sedation and fall risk (label/clinical).
Alcohol is contraindicated due to dose dumping risk with the extended-release formulation (label).

Monitoring & labs

Respiratory risk and CNS depressant co-medication review (label/clinical).
Safe storage and misuse/diversion monitoring consistent with REMS (label/clinical).
Nighttime fall risk assessment and environment planning (clinical).
Mood and neuropsychiatric symptom monitoring (label/clinical).
Hepatic impairment assessment and appropriateness of initiation (label).

Adverse effects

FDA boxed warnings

CNS depression and respiratory depression risk; abuse and misuse risk (boxed warning; label).

Common side effects (≥10%)

Nausea: Common; assess timing and titration steps (clinical).
Dizziness: Can contribute to falls, especially at night (label/clinical).
Somnolence: Expected pharmacologic effect; counseling focuses on safe nighttime routines (label/clinical).
Headache: Common; assess sleep disruption and co-medications (clinical).
Enuresis: Can occur; sleep disruption and planning may be needed (clinical).

Other notable effects

Falls and injuries can occur due to rapid sleep onset or confusion; safe nighttime environment planning and avoiding other sedatives reduces risk (label/clinical).
Misuse/diversion risk is addressed through REMS enrollment, safe storage, and monitoring, particularly in patients with substance use disorders (label/clinical).
Neuropsychiatric effects (confusion, parasomnias, depression, suicidal ideation) have been reported with oxybate products; monitoring is emphasized in serious mental illness and when other CNS depressants are present (label/clinical).

Interactions

Alcohol is contraindicated. Sedative-hypnotics and other CNS depressants are generally avoided due to additive CNS depression and respiratory depression risk (label).
Divalproex/valproate produces a modest exposure increase, but sedating pharmacodynamic interactions are still a concern; monitor closely if co-prescribed (label/clinical).
Opioids and benzodiazepines increase respiratory risk; when such agents are required, clinicians often reassess whether an oxybate product is appropriate (clinical).

Other useful information

Sodium burden can be clinically relevant at higher doses; review overall dietary sodium and comorbid cardiovascular disease when selecting between oxybate formulations (label/clinical).
Once-nightly dosing can improve feasibility for patients who cannot reliably wake for a second dose or for whom split-night dosing worsens sleep fragmentation (clinical).
Implementation topics (REMS enrollment, mixing instructions, safe storage, and avoidance of alcohol/sedatives) are reviewed explicitly at initiation and during titration (label/clinical).

References

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