Stiripentol is a prescription medicine indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. MedsAcross supplies Stiripentol 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.
DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more.
Source: US FDA prescribing information
The mechanism by which DIACOMIT exerts its anticonvulsant effect in humans is unknown. Possible mechanisms of action include direct effects mediated through the gamma-aminobutyric acid (GABA) A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and its active metabolite.
Source: US FDA prescribing information
The dosage of DIACOMIT is 50 mg/kg/day, administered by mouth in 2 or 3 divided doses, depending on age and weight. Capsules must be swallowed whole with a glass of water during a meal. Capsules should not be broken or opened. Powder for suspension should be mixed in a glass of water and should be taken immediately after mixing during a meal. Reduce dose or discontinue dose gradually.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Somnolence: Monitor for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants, If somnolence occurs during co-administration with clobazam, consider an initial reduction of clobazam by 25%. Decreased Appetite and Decreased Weight: the weight of patients and the growth rate of pediatric patients should be carefully monitored. Neutropenia and Thrombocytopenia: Blood counts should be obtained prior to starting treatment with DIACOMIT and then every 6 months. Withdrawal: DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. Risks in Patients with Phenylketonuria (PKU): DIACOMIT for oral suspension contains phenylalanine, consider total daily intake before prescribing to patients with PKU. Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behaviors.
Source: US FDA prescribing information
The following serious or otherwise clinically significant adverse reactions are described elsewhere in the labeling: Somnolence Decreased Appetite and Decreased Weight Neutropenia and Thrombocytopenia Withdrawal Symptoms Risks in Patients with Phenylketonuria Suicidal Behavior and Ideation Adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia.
Source: US FDA prescribing information
DIACOMIT increases the plasma concentration of clobazam and its metabolite through metabolic inhibition of CYP3A4 and CYP2C19. Consider dose reduction of clobazam in case of adverse reactions. Substrates of CYP2C8, CYP2C19, P-gp and BCRP may require a dose reduction. Substrates of CYP1A2, CYP2B6 and CYP3A4 may require a dose adjustment. Strong inducers of CYP1A2, CYP3A4 or CYP2C19: Consider dose increase of DIACOMIT.
Source: US FDA prescribing information
Store in a dry place at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original package to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Stiripentol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Diacomit 250 mg capsuleOral | Biocodex | US FDA | Available on request |
| Diacomit 250 mg powder for oral suspensionOral | Biocodex | US FDA | Available on request |
| Diacomit 500 mg capsuleOral | Biocodex | US FDA | Available on request |
| Diacomit 500 mg powder for oral suspensionOral | Biocodex | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Stiripentol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Stiripentol, including Diacomit.
Yes. The US FDA first approved Stiripentol on 20 August 2018, according to Drugs@FDA.
Yes. Stiripentol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Stiripentol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Stiripentol is classified under ATC code N03AX17 (Stiripentol).
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