Stiripentol

What it is and how it works

Mechanism of Action 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.

Indications

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 . There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

Dosage and administration (summary)

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. Laboratory Tests Prior to First Dose of DIACOMIT Hematologic testing should be obtained prior to starting treatment with DIACOMIT .

Contraindications

None. None

Warnings and precautions

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.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Storage and supply

How Supplied DIACOMIT Capsules 250 mg: size 2, pink, and imprinted with “Diacomit” and “250mg” are supplied as follows: Bottles of 60 NDC 68418-7939-6 500 mg: size 0, white, and imprinted with “Diacomit” and “500mg” are supplied as follows: Bottles of 60 NDC 68418-7940-6 For Oral Suspension 250 mg: pale pink fruit flavored powder packaged in packet…

Source: Stiripentol (Diacomit) — US FDA prescribing information, 2026-04-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.