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Stiripentol (STIR i PEN tol) has been approved by the FDA to treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take stiripentol? (Available formulations)

Stiripentol is available as a capsule and an oral powder and should be taken during a meal. In pediatric patients, the oral powder must be mixed with water and food must be eaten right after.

Who should not take stiripentol?

Some considerations may influence whether you should take stiripentol. Tell your healthcare provider if you:

  • have liver or kidney problems.
  • have phenylketonuria (PKU), as the oral solution form of stiripentol contains aspartame, which may be harmful to people with PKU.
  • have or have had depression, mood problems, suicidal thoughts, or behavior.
  • drink alcohol.
  • are pregnant or plan to become pregnant.
  • are breastfeeding, or plan to breastfeed.

What is important to know about taking stiripentol?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking stiripentol with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Do not stop taking stiripentol suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, stiripentol should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using stiripentol suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

Women or those who are/plan to become pregnant
Use in pregnancy

It is not known if stiripentol may harm your unborn baby. At this time, there is no useful evidence regarding developmental risks associated with the use of stiripentol in pregnant people. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

If you become pregnant while taking stiripentol, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Use during breastfeeding

It is not known if stiripentol is present in breast milk. It is also unknown if there are effects on the breastfed infant, or if stiripentol impacts milk production. Talk to your healthcare provider about the best way to feed your baby while taking stiripentol. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for stiripentol and the potential effect on the infant from stiripentol or from your epilepsy.

What are the side effects of stiripentol?

Stiripentol is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by stiripentol can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Common side effects

The most common side effects that were reported in studies of stiripentol are agitation, tremor, problems with movement and balance (ataxia), trouble saying words clearly (dysarthria), low muscle tone, or muscle weakness (hypotonia), trouble sleeping (insomnia), and nausea.

Rare, but serious side effects
Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including stiripentol may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Somnolence

Sleepiness and drowsiness (somnolence) are serious and common side effects. Stiripentol can make you sleepy or dizzy, and slow your thinking. Your healthcare provider may decrease your dose of stiripentol or other seizure medicines.

Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking stiripentol until you talk to your healthcare provider. Stiripentol, when taken with alcohol or medicines that cause sleepiness or dizziness, may make your sleepiness or dizziness worse.

Do not drive or operate machinery until you have gained sufficient experience on stiripentol to gauge whether it adversely affects your abilities.

Decreased appetite and decreased weight

Loss of appetite and weight loss are serious and common side effects. Stiripentol can cause frequent nausea and loss of appetite that can cause weight loss. Your weight should be checked frequently during treatment. Children who take stiripentol should have their weight and growth checked often.

Neutropenia and thrombocytopenia

Low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia) may occur during treatment with stiripentol. Low white blood cell counts may cause serious infections. Low platelet counts may cause serious bleeding problems. Your healthcare provider should check your white blood cell count and platelet count before and during treatment (approximately every 6 months).