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Cenobamate (SEN oh BAM ate) has been approved by the FDA to treat focal onset seizures in adult patients.

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 cenobamate? (Available formulations)

Cenobamate is available as a tablet that can be taken by mouth with or without food.

Who should not take cenobamate?

If you are allergic to cenobamate or any of the inactive ingredients, then you should not take it.

If you have a genetic heart rhythm disorder called Familial Short QT syndrome then you should not take cenobamate as it has been found to aggravate it. If you or a family member have a family history of heart troubles, please let your healthcare provider know.

Other considerations may influence whether you should take cenobamate. Tell your healthcare provider if you:

  • have or have had depression, mood problems, or suicidal thoughts or actions.
  • have liver, kidney, or blood problems.
  • have had an allergic reaction to a medicine that caused a rash or affected internal organs, like the liver or blood cells.
  • use birth control medicine.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking cenobamate?

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

As with all antiseizure medications, cenobamate should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus.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

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

Taking cenobamate 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. Especially tell your healthcare provider if you take: drugs that cause sleepiness or dizziness.

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

At this time, there is not enough evidence regarding developmental risks associated with the use of cenobamate in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. 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 cenobamate, 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 may not be safe to breastfeed while taking cenobamate. It is not known if cenobamate is present in breast milk, if there are effects on the breastfed infant, or if cenobamate impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for cenobamate and the potential effect on the infant from cenobamate or from your epilepsy.

Effect on birth control

Cenobamate may decrease the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using cenobamate, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

What are the side effects of cenobamate?

Cenobamate 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 cenobamate 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 cenobamate are drowsiness (somnolence), dizziness, fatigue, diplopia, and headache.

Rare, but serious side effects
QT shortening

While taking cenobamate, you may develop QT shortening, which is a problem with the electrical system of the heart. Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Serious reactions, including serious blood or liver problems

Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with cenobamate use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, weakness, fatigue, yellowing of your skin, or the white part of your eyes, trouble walking or seeing, seizures happening more often, or pain/tenderness in the area toward the top of your stomach (enlarged liver/spleen).

Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including cenobamate 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.

Neurological reactions

Cenobamate may cause problems that can affect your nervous system. Symptoms of nervous system problems include dizziness, trouble walking or with coordination, feeling sleepy and tired, vision problems, and trouble concentrating, remembering, and thinking clearly. The amount of sleepiness and fatigue you may experience is related to the dose you take.

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