Stiripentol
Stiripentol is an anticonvulsant (anti-seizure) medication used together with clobazam to treat seizures associated with Dravet syndrome.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Stiripentol: Patient Information Guide
A plain-language walkthrough of Stiripentol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Stiripentol is used as an add-on anti-seizure medicine for a specific type of epilepsy.
- Diacomit (capsule or oral suspension, taken by mouth) is indicated for the treatment of seizures associated with Dravet syndrome in patients who are also taking clobazam, are at least 6 months of age, and weigh 7 kg or more.
- Diacomit is not approved or supported by clinical data for use as a standalone (monotherapy) treatment for Dravet syndrome — it must be used alongside clobazam.
⚙️How it works▾
The exact way stiripentol stops seizures in people is not fully known. Two possible mechanisms have been identified. First, it may act directly on GABA-A receptors — proteins in the brain that help calm electrical activity — potentially making them work more effectively. Second, stiripentol slows down liver enzymes (particularly CYP3A4 and CYP2C19) that normally break down clobazam. This causes clobazam and its active byproduct (norclobazam) to accumulate to much higher levels in the blood — roughly double for clobazam and five times higher for norclobazam — amplifying the overall seizure-suppressing effect of the combination.
💊How it's taken▾
Diacomit is taken by mouth, in two or three divided doses per day, depending on the patient's age and body weight. Both the capsule and the oral suspension should be taken with a meal. Diacomit capsules must be swallowed whole — never broken or opened. The oral suspension is mixed in water and drunk immediately after mixing, followed by a water rinse of the glass. If a dose is missed, take it as soon as you remember unless it is almost time for the next one — in that case, skip the missed dose and continue as normal. Never take two doses at once. If Diacomit needs to be stopped, it should be tapered (reduced gradually) rather than stopped suddenly, to reduce the risk of worsening seizures.
🤒Side effects — in detail▾
The most common side effects reported with Diacomit include:
- Drowsiness or sleepiness (somnolence) — affects the majority of patients
- Decreased appetite and weight loss
- Agitation or irritability
- Unsteady movement or poor coordination (ataxia)
- Muscle weakness (hypotonia)
- Nausea and vomiting
- Tremor (shaking)
- Slurred speech (dysarthria)
- Trouble sleeping (insomnia)
More serious reactions include low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), significant weight loss in growing children, and increased risk of suicidal thoughts — all of which require prompt medical attention.
⚠️Warnings & precautions▾
- Drowsiness: Diacomit causes heavy sedation in most patients, made worse because it raises clobazam levels. Avoid driving or dangerous activities until alertness is established. Alcohol and other sedating medicines make this worse.
- Decreased appetite and weight loss: Nearly half of patients in trials experienced appetite loss and more than a quarter lost weight. Growth should be monitored closely in children.
- Low blood cell counts: Diacomit can cause neutropenia (low white blood cells) and thrombocytopenia (low platelets), raising the risk of infection and bleeding. Blood counts must be checked before starting and every 6 months.
- Suicidal thoughts and behavior: Like all anti-epileptic drugs, Diacomit is associated with a small increased risk of suicidal thinking or behavior. Report any mood changes, depression, or talk of self-harm to a healthcare provider immediately.
- Do not stop suddenly: Stopping Diacomit abruptly can trigger a dangerous increase in seizures or status epilepticus (a prolonged seizure emergency). Always taper gradually under medical supervision.
- Phenylketonuria (PKU): The oral suspension form contains phenylalanine. Patients with PKU should use the capsule form or discuss total phenylalanine intake with their doctor.
🔀What it interacts with▾
Stiripentol affects — and is affected by — several important medications and substances:
- Clobazam: Diacomit raises clobazam and norclobazam levels substantially, increasing the risk of clobazam side effects; a dose reduction of clobazam may be necessary.
- Alcohol and other CNS depressants (sedating medicines): These increase drowsiness and sedation — avoid combining with Diacomit.
- Strong enzyme inducers (rifampin, phenytoin, phenobarbital, carbamazepine): These can lower stiripentol levels in the blood, reducing its effectiveness; co-use should be avoided or doses adjusted.
- CYP1A2 substrates (e.g., theophylline, caffeine): Diacomit may alter their levels; dose adjustment may be needed.
- CYP2B6 substrates (e.g., sertraline): Diacomit may affect their metabolism; monitor for side effects.
- CYP3A4 substrates (e.g., midazolam, triazolam, quinidine): Diacomit may increase their exposure; dose adjustment may be needed.
- CYP2C19 and CYP2C8 substrates (e.g., diazepam, clopidogrel): Diacomit inhibits their breakdown; dose reductions may be needed if side effects occur.
- P-gp and BCRP substrates (e.g., carbamazepine, methotrexate, glyburide): Diacomit may raise their blood levels; monitor carefully.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Kidney disease: Diacomit is not recommended for patients with moderate or severe kidney impairment, as its breakdown products are cleared mainly through the kidneys.
- Liver disease: Diacomit is not recommended for patients with moderate or severe liver impairment, as the drug is primarily metabolized by the liver.
- Phenylketonuria (PKU): The oral suspension form of Diacomit contains phenylalanine; patients with PKU must factor this into their total daily phenylalanine intake. The capsule form does not contain phenylalanine.
- Pregnancy: Animal studies show Diacomit may cause fetal harm, including malformations and increased fetal mortality. Pregnant patients should be enrolled in the NAAED Pregnancy Registry (1-888-233-2334). Discuss risks and benefits with your doctor.
- Breastfeeding: It is not known whether stiripentol passes into human breast milk. Weigh the benefits of breastfeeding against any potential risks with your healthcare provider.
- Young children: Safety and effectiveness have not been established in children under 6 months of age or weighing less than 7 kg.
- Older adults (65+): Clinical studies did not include patients 65 and older. Age-related changes in liver and kidney function should be considered when using Diacomit in this group.
- Blood tests required: A blood count must be done before starting Diacomit and every 6 months to monitor for low white blood cell and platelet counts.
🚑If you take too much▾
There is no human overdose data for stiripentol. In animal studies, very high doses caused reduced movement and slowed breathing. If an overdose is suspected, treatment is supportive — meaning symptoms are managed, typically in a hospital or intensive care setting. Contact your regional Poison Control Center immediately if an overdose is suspected.
🔬Pharmacokinetics — how your body processes it▾
After a dose of Diacomit, stiripentol reaches its peak level in the blood within about 2 to 3 hours. It binds very tightly to proteins in the blood (99% protein-bound). In adults, the drug is cleared from the body with a half-life (the time for blood levels to fall by half) of roughly 4.5 to 13 hours, and this increases with higher doses. In children with Dravet syndrome, the half-life is longer and depends on body weight — ranging from about 8.5 hours in a 10 kg child to over 23 hours in a 60 kg child. Stiripentol is broken down mainly by liver enzymes (CYP1A2, CYP2C19, and CYP3A4), and its byproducts are cleared through the kidneys, which is why the drug is not recommended in people with significant liver or kidney disease.
📦How to store it▾
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.
📄 Written from Stiripentol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Stiripentol
18 supplements and herbal products have documented interactions with Stiripentol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 8
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Stiripentol — the kind of thing our pharmacy team would talk through with you at the counter.
Why does my child need to take this medication with clobazam? Can they take it alone? ▾
My child seems very sleepy since starting Diacomit. Is that normal, and what should I do? ▾
I noticed my child is eating less and losing weight. Is Diacomit causing this? ▾
Why does my child need blood tests every 6 months while on this medication? ▾
Can we just stop Diacomit if we decide it's not working or the side effects are too much? ▾
Is it safe to take Diacomit during pregnancy? ▾
Is Stiripentol available over the counter? ▾
When was Stiripentol first available? ▾
Who makes Stiripentol? ▾
💬 Answers drafted from Stiripentol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Stiripentol comes
Stiripentol is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Diacomit capsules are used to treat seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weigh at least 7 kg
- Diacomit capsules must be swallowed whole — do not break or open them
- Diacomit capsules should be taken with a full glass of water during a meal
- Diacomit capsules do not contain phenylalanine and may be an option for patients with PKU
Oral suspension
How this form is used
- Diacomit oral suspension is used to treat seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weigh at least 7 kg
- Diacomit oral suspension powder should be mixed into approximately 100 mL of water and taken immediately after mixing during a meal
- After drinking, add about 25 mL of water to the same cup and drink the rinse to ensure no medicine is left behind
- Diacomit oral suspension contains phenylalanine — patients with phenylketonuria (PKU) should discuss this with their doctor before use
📊 Stiripentol across the U.S. market
How Stiripentol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Stiripentol is used
A general measure of how commonly Stiripentol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Stiripentol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Stiripentol prescribed? Of the 1,596 medications we measure, Stiripentol ranks #1,122 by Medicaid prescriptions — more than 30% of them.
Utilization by Stiripentol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
stiripentol 250 MG Oral Capsule Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2054973
stiripentol 250 MG Powder for Oral Suspension
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055015
stiripentol 500 MG Oral Capsule
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2054981
stiripentol 500 MG Powder for Oral Suspension
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055011
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Stiripentol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 4 listed Stiripentol NDCs with Medicaid activity.
🔍 Compare Stiripentol products
A representative set of FDA-listed product records for Stiripentol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | Oral | Biocodex, Inc. × 2 listings | NDA | View NDC → |
| 500 mg | Oral | Biocodex, Inc. × 2 listings | NDA | View NDC → |
| 💊Oral suspension | ||||
| 250 mg | Oral | Biocodex, Inc. × 2 listings | NDA | View NDC → |
| 500 mg | Oral | Biocodex, Inc. × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 15 kg/15 kg | — | Metrochem API Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited | BULK INGREDIENT | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Stiripentol NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Stiripentol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Stiripentol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Stiripentol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2054968 2 dose forms · 4 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 2054972In current FDA listings -
Dose form (SCDF) Powder for Oral Suspension RxCUI 2055010In current FDA listings
Look up RxCUI 2054968 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Stiripentol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Stiripentol belongs to the Other antiepileptics class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Biocodex, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.