Medication Monitor

Generic Name (Trade Name—Company)
August 28, 2018


Stiripentol now approved for seizures associated with Dravet syndrome

FDA approved stiripentol for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy. Stiripentol is indicated for use in patients aged 2 years and older who are taking clobazam. There are no clinical data to support the use of stiripentol as monotherapy in Dravet syndrome.   

Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures. Later, other types of seizures typically appear, including myoclonic seizures. In addition, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.

The most common adverse effects reported with stiripentol are somnolence, decreased appetite, agitation, impaired coordination and balance, weight loss, low muscle tone, nausea, tremor, dysarthria, and insomnia.   

Stiripentol must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks. As is true for many other drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.