Molecule
Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. MedsAcross supplies Sodium oxybate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Source: US FDA prescribing information
Xyrem is a CNS depressant. The mechanism of action of Xyrem in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of Xyrem on cataplexy and excessive daytime sleepiness are mediated through GABA B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.
Source: US FDA prescribing information
Dosage for Adult Patients • Initiate dosage at 4.5 g per night orally, divided into two doses. • Titrate to effect in increments of 1.5 g per night at weekly intervals (0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later). • Recommended dosage range: 6 g to 9 g per night orally. Total Nightly Dose Take at Bedtime Take 2.5 to 4 Hours Later 4.5 g per night 2.25 g 2.25 g 6 g per night 3 g 3 g 7.5 g per night 3.75 g 3.75 g 9 g per night 4.5 g 4.5 g Dosage for Pediatric Patients (7 years of Age and Older) • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight. Important Administration Information • Prepare both doses prior to bedtime, dilute each dose with approximately ¼ cup of water in pharmacy-provided containers. • Allow 2 hours after eating before dosing. • Take each dose while in bed and lie down after dosing.
Source: US FDA prescribing information
Xyrem is contraindicated for use in: • combination with sedative hypnotics. • combination with alcohol. • patients with succinic semialdehyde dehydrogenase deficiency. • In combination with sedative hypnotics or alcohol. • Succinic semialdehyde dehydrogenase deficiency
Source: US FDA prescribing information
Boxed warning (central nervous system depression and abuse and misuse. •): Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem. Many patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants. • CNS depression: Use caution when considering the concurrent use of Xyrem with other CNS depressants. • Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. • Depression and suicidality: Monitor patients for emergent or increased depression and suicidality.
Source: US FDA prescribing information
The following clinically significant adverse reactions appear in other sections of the labeling: • CNS depression • Abuse and Misuse • Respiratory Depression and Sleep-Disordered Breathing • Depression and Suicidality • Other Behavioral or Psychiatric Adverse Reactions • Parasomnias • Use in Patients Sensitive to High Sodium Intake Most common adverse reactions in adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. Most common adverse reactions in pediatric patients (≥5%) were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking.
Source: US FDA prescribing information
• Concomitant use with divalproex sodium: An initial reduction in Xyrem dose of at least 20% is recommended. Alcohol, Sedative Hypnotics, and CNS Depressants Xyrem is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of Xyrem. Divalproex Sodium Concomitant use of Xyrem with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. An initial dose reduction of Xyrem is recommended when used concomitantly with divalproex sodium. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of Xyrem and divalproex sodium is warranted.
Source: US FDA prescribing information
Xyrem should be stored at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Storage Keep out of reach of children.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Sodium oxybate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sodium oxybate 0.5 g/mL oral solutionOralGeneric name | — | US FDA | Available on request |
| Lumryz 4.5 g powder for extended-release oral suspensionOral | Alkermes | US FDA | Available on request |
| Lumryz 6 g powder for extended-release oral suspensionOral | Alkermes | US FDA | Available on request |
| Lumryz 7.5 g powder for extended-release oral suspensionOral | Alkermes | US FDA | Available on request |
| Lumryz 9 g powder for extended-release oral suspensionOral | Alkermes | US FDA | Available on request |
| Lumryz kit | Alkermes | US FDA | Available on request |
| Xyrem 0.5 g/mL oral solutionOral | Jazz Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Sodium oxybate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 7 presentations of Sodium oxybate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Sodium oxybate, including Lumryz, Xyrem.
Yes. The US FDA first approved Sodium oxybate on 17 July 2002, according to Drugs@FDA.
Yes. Sodium oxybate has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Sodium oxybate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sodium oxybate is classified under ATC code N01AX11 (Sodium oxybate).
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