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ganaxolone

Ztalmy · ATC code N03AX

Also known as: Ganaxolon, Ganaksolon

Key facts
Active substance
ganaxolone
Drug class
Anticonvulsant agent
ATC code
N03AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ZTALMY 50 mg/mL oral suspension
Marketing authorisation holder
Marinus Pharmaceuticals Emerald Limited
Information as of
2026-10-29

Key facts

Ganaxolone is an anti-seizure medicine, a neuroactive steroid. It is used as adjunctive treatment of seizures in CDKL5 deficiency disorder in children and adolescents.

What it is used for

  • Adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder (CDD) in patients 2 to 17 years of age; may be continued in patients 18 years and older.

Dosing

  • Ztalmy (oral suspension): titrate gradually by clinical response and tolerability; give 3 times a day, ideally as three equal doses.
  • Patients ≤ 28 kg: recommended maximum daily dose 63 mg/kg/day in three separate doses (every 8 hours); a minimum dose of 33 mg/kg/day is generally required.
  • Weight-based titration schedule and dosing for patients above 28 kg – see the full text.
  • Severe hepatic impairment (Child-Pugh C): dose adjustment recommended.
  • Do not stop abruptly; taper unless symptoms require immediate discontinuation.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Somnolence and sedation; other CNS depressants (anti-seizure medicines, opioids, antidepressants, alcohol) may potentiate this.
  • Suicidal behaviour and ideation with anti-epileptic drugs; caregivers should watch for signs.
  • Patients should not use alcohol during treatment.
  • Avoid strong CYP3A4 inducers, as they reduce exposure.
  • Potential for abuse; abrupt discontinuation may cause withdrawal symptoms.

Side effects

  • Most common: somnolence (29.4%) and pyrexia (23.5%).
  • Others: sedation, hypersomnia, lethargy, drooling/salivary hypersecretion.

Interactions

  • Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, primidone, St John's wort) reduce ganaxolone exposure; a dose increase may be needed without exceeding the maximum daily dose.
  • CYP3A4 inhibitors: changes not expected to be clinically significant.
  • Other CNS depressants and alcohol increase sedation.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Excreted in human milk; a risk to the child cannot be excluded.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

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)

  • ZtalmyMarinus Pharmaceuticals Emerald Limited · EMEA/H/C/005825

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Ztalmy
Liechtenstein
Ztalmy
Norway
Ztalmy

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Ztalmy – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/ztalmy-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N03AX.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.