Sodium oxybate

Xyrem · ATC code N07XX04

Brand names: Xyrem, Alcover, Natriumoxybat Kalceks, Natriumoxybat Neuraxpharm, Natriumoxybat Accord, Natriumoxybat Aristo, Natriumoxybat Ascend, Natriumoxybat Ethypharm, Somsanit

Key facts
Active substance: Sodium oxybate
ATC code: N07XX04
Authorisation: centrally authorised across the EU (EMA)
Dosage forms: Xyrem 500 mg/mL oral solution
Marketing authorisation holder: UCB Pharma Ltd
Information as of: 2026-10-27

Key facts

Sodium oxybate is a CNS depressant, the sodium salt of gamma-hydroxybutyrate (Xyrem oral solution). It is used to treat narcolepsy with cataplexy from 7 years of age.

What it is used for

Narcolepsy with cataplexy in adults, adolescents and children from 7 years of age

Dosing

Adults: start 4.5 g/day divided into two equal doses of 2.25 g
Titrate in steps of 1.5 g/day (0.75 g/dose) at intervals of one to two weeks; maximum 9 g/day
With valproate: reduce dose by 20%; starting dose 3.6 g per day
Hepatic impairment: halve the starting dose
After more than 14 consecutive days off, restart titration from the lowest dose
Weight-based paediatric dosing is in the full text

Contraindications

Hypersensitivity to the active substance or any of the excipients
Major depression
Succinic semialdehyde dehydrogenase deficiency
Concomitant treatment with opioids or barbiturates

Important warnings

Respiratory and CNS depression; assess for sleep apnoea before treatment
Monitor patients with BMI ≥40 kg/m2 closely
Avoid benzodiazepines
Most serious reactions: suicidal attempt, psychosis, respiratory depression, convulsion
Monitor elderly for impaired motor and cognitive function; consider sodium content in renal impairment

Side effects

Most common: dizziness, nausea and headache (in 10% to 20% of adults)
Serious: suicidal attempt, psychosis, respiratory depression, convulsion
Choking sensation during sleep reported

Interactions

Alcohol potentiates CNS depression; avoid alcoholic beverages
Not used with sedative hypnotics or other CNS depressants
Valproate: reduce the sodium oxybate dose

Pregnancy and breastfeeding

Not recommended during pregnancy; possible increased risk of spontaneous abortion with first-trimester exposure

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

XyremUCB Pharma Ltd · EMEA/H/C/000593

Source: European Medicines Agency (EMA), product information

Austria

AlcoverDebregeas Et Associes Pharma · 1 register entry
Natriumoxybat KalceksKalceks · 1 register entry
Natriumoxybat NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

Natriumoxybat AccordAccord Healthcare B.V. · 1 register entry
Natriumoxybat AristoAristo Pharma Gmbh (Art 57) · 1 register entry
Natriumoxybat AscendAscend Gmbh · 1 register entry
Natriumoxybat EthypharmKalceks · 1 register entry
Natriumoxybat NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
SomsanitDr. Franz Köhler Chemie Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

XyremUCB PHARMA A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 20 more European countries

Belgium: Oxybate Accord, Oxybate Kalceks
Czechia: Sodium Oxybate Kalceks
Denmark: Natriumoxybat, Oxiore
Estonia: Sodium Oxybate Kalceks
Finland: Natriumoksibaatti Kalceks, Natriumoxibat Reig Jofre
France: Gamma-Oh, Oxybate De Sodium Kalceks, Oxybate De Sodium Reig Jofre
Greece: Oxybatin
Iceland: Xyrem
Ireland: Sodium Oxybate As Kalceks
Italy: Alcover, Sodio Oxibato Accord, Sodio Oxibato Kalceks
Latvia: Nartex
Liechtenstein: Xyrem
Lithuania: Sodium Oxybate Kalceks
Netherlands: Natriumoxybaat Accord, Natriumoxybaat Aristo, Natriumoxybaat Kalceks, Oxiore
Norway: Natriumoksybat Kalceks, Oxiore, Xyrem
Poland: Sodium Oxybate Accord
Slovakia: Sodium Oxybate Kalceks
Slovenia: Natrijev Oksibat Accord, Natrijev Oksibat Kalceks
Spain: Anartex, Oxibato De Sodio Kalceks, Oxibato De Sodio Normon, Oxibato De Sodio Zentiva, Oxibato Sódico Sala
Sweden: Natriumoxibat Kalceks, Natriumoxibat Reig Jofre, Oxiore

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

European Medicines Agency. Xyrem – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xyrem-epar-product-information_en.pdf
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.