Diacomit (stiripentol)
An approved treatment for Dravet Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Stiripentol wherever you encounter it, plus the key facts at a glance.
- Generic name
- Stiripentol
- Brand name
- Diacomit
- Drug class
- GABA-enhancing anticonvulsant
- Manufacturer
- Biocodex
- How it's taken
- Taken by mouth as capsules (250 mg or 500 mg) or oral suspension packets, in 2-3 divided doses daily with meals.
An add-on seizure medication that strengthens the brain's natural calming signals (GABA) to reduce seizure frequency in Dravet syndrome. Approved for people 6 months and older who weigh at least 7 kg and are also taking clobazam.
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Where Stiripentol fits
Add-on anti-seizure therapy for Dravet syndrome in people taking clobazam, often alongside valproate. One of 3 FDA-approved add-on treatments specifically for Dravet seizures.
How Stiripentol works
Stiripentol works by boosting GABA, the brain's main calming chemical. It extends how long GABA receptors stay open, giving the calming signal more time to work. It may also slow down the breakdown of GABA so more of it stays active in the brain. This helps reduce the excessive electrical activity that causes seizures.
Mechanism: Enhances GABAergic neurotransmission by extending GABA-A receptor chloride channel opening time, and may reduce GABA reuptake and degradation
Side effects and safety
Common side effects include decreased appetite, weight loss, fatigue, drowsiness, coordination problems (ataxia), tremor, agitation, behavioral changes, insomnia, and nausea. Stiripentol can lower white blood cell and platelet counts, so blood counts are checked before starting and every 6 months. Like other seizure medicines, it can rarely cause suicidal thoughts, and it should not be stopped suddenly. The label also warns that drowsiness can be stronger with other medicines that cause sleepiness, and that the oral suspension powder contains phenylalanine, which matters for people with phenylketonuria (PKU).
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Stiripentol
Taken by mouth as capsules (250 mg or 500 mg) or oral suspension packets, in 2-3 divided doses daily with meals. The typical dose is 50 mg/kg/day, up to a maximum of 3,000 mg/day. Must be taken with food.
Availability and cost
Only available as the brand-name product.
Orphan anti-seizure medication specifically for Dravet syndrome, used as add-on therapy. Ultra-rare disease indication with limited manufacturing scale.
Help paying for Diacomit
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients pay $0 per prescription. Not available for government plans such as Medicare or Medicaid.
For: private insurance · source - Bridge or quick-start supply
Quick Start Program: up to 60 days of Diacomit at no cost for new patients facing delays getting access to treatment.
The official page does not say who qualifies. Ask the program. · source - Bridge or quick-start supply
Bridge Program: up to 60 days of Diacomit at no cost for current patients with changes or lapses in insurance coverage.
The official page does not say who qualifies. Ask the program. · source - Free medicine program
Long-Term Patient Assistance Program provides Diacomit at no cost to eligible uninsured or underinsured patients.
For: no insurance, underinsured · source - Insurance and case manager help
Support team at PANTHERx Rare Pharmacy helps with insurance coverage and savings eligibility, refills and delivery.
The official page does not say who qualifies. Ask the program. · source
Good to know: Diacomit is dispensed only through PANTHERx Rare Pharmacy.
- From a charity · Dravet Syndrome FoundationPatient Assistance Grant (PAG) Program fundOpen
Pays for: Medical equipment, therapy devices and educational aids, up to $1,500 per year.
The foundation says: “Our grant application period runs from January 1st – November 30th each year. We cannot accept applications during the month of December.”
Clinical trial results
2 placebo-controlled trials (STICLO France, 41 patients, and STICLO Italy, 23 patients) in children already taking clobazam and valproate showed that 71% and 67% of patients on stiripentol had their generalized clonic or tonic-clonic seizures cut by more than half, versus 5% and 9% on placebo. Across its development, 438 people with Dravet syndrome received stiripentol, 310 of them for 12 months or more.
Development history
Originally approved in Europe in 2007, stiripentol received FDA approval in August 2018 for Dravet syndrome specifically. It is one of three FDA-approved treatments for Dravet and is typically used as part of a combination regimen with clobazam and valproate.
Explore Dravet Syndrome trials
Other Dravet Syndrome treatments
Stiripentol in Trial Friend News and Guides
Common questions about Stiripentol
▸What is Stiripentol (Diacomit)?
An add-on seizure medication that strengthens the brain's natural calming signals (GABA) to reduce seizure frequency in Dravet syndrome. Approved for people 6 months and older who weigh at least 7 kg and are also taking clobazam.
▸How does Stiripentol work?
Stiripentol works by boosting GABA, the brain's main calming chemical. It extends how long GABA receptors stay open, giving the calming signal more time to work. It may also slow down the breakdown of GABA so more of it stays active in the brain. This helps reduce the excessive electrical activity that causes seizures.
▸What are the side effects of Stiripentol?
Common side effects include decreased appetite, weight loss, fatigue, drowsiness, coordination problems (ataxia), tremor, agitation, behavioral changes, insomnia, and nausea. Stiripentol can lower white blood cell and platelet counts, so blood counts are checked before starting and every 6 months. Like other seizure medicines, it can rarely cause suicidal thoughts, and it should not be stopped suddenly. The label also warns that drowsiness can be stronger with other medicines that cause sleepiness, and that the oral suspension powder contains phenylalanine, which matters for people with phenylketonuria (PKU).
▸How is Stiripentol taken?
Taken by mouth as capsules (250 mg or 500 mg) or oral suspension packets, in 2-3 divided doses daily with meals. The typical dose is 50 mg/kg/day, up to a maximum of 3,000 mg/day. Must be taken with food.
▸Is Stiripentol FDA approved?
Yes, Stiripentol (Diacomit) is FDA approved (2018) for the treatment of Dravet Syndrome.
▸Does stiripentol have to be used with clobazam and valproate?
Stiripentol is approved for people with Dravet syndrome who are taking clobazam. Valproate is not required by the label, although patients in the original trials were on both clobazam and valproate. It works partly by inhibiting the liver enzymes that break down clobazam, effectively increasing clobazam levels in the body and enhancing its anti-seizure effect. Without clobazam, much of stiripentol's clinical benefit may be lost. The three-drug combination has the strongest evidence base for seizure reduction in Dravet syndrome.
▸How does stiripentol compare to cannabidiol and fenfluramine?
All three are FDA-approved add-on therapies for Dravet syndrome, but they work through different mechanisms. Stiripentol enhances GABA signaling and boosts clobazam levels, cannabidiol (Epidiolex) works in a way that is not fully understood, and fenfluramine (Fintepla) activates serotonin pathways. The choice depends on the individual patient's seizure control, current medications, and tolerability. Many Dravet patients require multiple anti-seizure medications.
▸What dietary considerations apply to stiripentol?
Stiripentol should be taken with food to improve absorption. It comes as capsules or powder packets that can be mixed with water. The powder has a bitter taste. Because stiripentol interacts with many liver enzymes (CYP450), it can affect levels of other medications, and dietary factors that influence these enzymes should be discussed with your physician.
▸Is stiripentol available as a generic?
No. Stiripentol (Diacomit) is not available as a generic in the United States. No generic version has been approved by the FDA. The drug is manufactured by Biocodex and distributed through specialty pharmacies.
▸What monitoring is needed while taking stiripentol?
Regular blood tests to monitor liver function, complete blood counts, and levels of other anti-seizure medications (particularly clobazam and valproate) are recommended. Because stiripentol increases clobazam levels, dose adjustments of clobazam may be necessary. Growth and nutritional status should also be monitored, as decreased appetite and weight loss are common side effects.