stiripentol
Diacomit · ATC code N03AX17
- Key facts
- Active substance
- stiripentol
- Drug class
- Anticonvulsant agent
- ATC code
- N03AX17
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Diacomit 250 mg hard capsules · Diacomit 500 mg hard capsules · Diacomit 250 mg powder for oral suspension in sachet · Diacomit 500 mg powder for oral suspension in sachet
- Marketing authorisation holder
- Biocodex
- Information as of
- 2026-10-29
Key facts
Stiripentol is an antiepileptic medicine. It is used with clobazam and valproate as adjunctive therapy for refractory generalised tonic-clonic seizures in Dravet syndrome.
What it is used for
- Adjunctive therapy with clobazam and valproate for refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet syndrome) not adequately controlled with clobazam and valproate (Diacomit capsules and powder for oral suspension).
Dosing
- Dosed in mg/kg body weight, in 2 or 3 divided doses; recommended dose 50 mg/kg/day together with clobazam and valproate.
- Gradual escalation: 20 mg/kg/day for 1 week, then 30 mg/kg/day for 1 week; then by age: under 6 years an additional 20 mg/kg/day in the third week; 6 to under 12 years an additional 10 mg/kg/day each week; 12 years and older an additional 5 mg/kg/day each week until the optimum dose.
- Always take with food, not with dairy products, carbonated drinks, fruit juice or food and drinks containing caffeine or theophylline.
- Under 3 years: individual decision; the clobazam dose was reduced by 25% every week if adverse reactions (e.g. drowsiness, hypotonia) occurred. See the full text for details.
- Not recommended in impaired hepatic and/or renal function.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
- A past history of psychoses in the form of episodes of delirium.
Important warnings
- Carbamazepine, phenytoin and phenobarbital should not be used with stiripentol in Dravet syndrome.
- Monitor children's growth, as gastrointestinal reactions (loss of appetite, nausea, vomiting) are frequent.
- Neutropenia may occur: check blood counts before starting and every 6 months.
- Check liver function before starting and every 6 months.
Side effects
- Most common: anorexia, weight loss, insomnia, drowsiness, ataxia, hypotonia and dystonia.
- Others: neutropenia, aggressiveness, irritability, behaviour disorders, hyperkinesias, nausea, vomiting, diplopia, photosensitivity, rash, raised γ-GT, thrombocytopenia, pneumonia including aspiration pneumonia.
Interactions
- Stiripentol inhibits CYP2C19, CYP2D6 and CYP3A4, among others, and can markedly raise levels of other medicines; clobazam levels rose about two- to three-fold.
- Caution with substances that inhibit or induce CYP1A2, CYP2C19 or CYP3A4.
Pregnancy and breastfeeding
- Effective antiepileptic therapy should not be interrupted during pregnancy; see the full text for the risk of stiripentol and for breast-feeding.
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.
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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)
- DiacomitBiocodex · EMEA/H/C/000664
Source: European Medicines Agency (EMA), product information
Brand names in 4 more European countries
- Iceland
- Diacomit
- Liechtenstein
- Diacomit
- Netherlands
- Stiripentol Billev
- Norway
- Diacomit
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?
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Sources
- European Medicines Agency. Diacomit – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/diacomit-epar-product-information_en.pdf
- 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.