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Clobazam (KLOE ba zam) has been approved by the FDA as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older.

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 clobazam? (Available formulations)

Clobazam is available as a tablet, taken crushed or whole, and an oral suspension. Both formulations can be taken with or without food.

Who should not take clobazam?

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

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

  • have or have had depression, mood problems, or suicidal thoughts or behavior.
  • have liver or kidney problems.
  • have lung problems.
  • have abused or been dependent on prescription medicines, street drugs, or alcohol.
  • use birth control medicine.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking clobazam?

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

As with all antiseizure medications, clobazam should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using clobazam 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 clobazam 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: opioids, drugs that cause sleepiness or dizziness, or alcohol.

Boxed warning

Clobazam 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 clobazam 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.

Use with opioids or other central nervous system depressants

Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other central nervous system depressants as they also may slow your breathing. If you are administered clobazam, your healthcare providers will watch you for symptoms such as weak or shallow breathing.

Tell your healthcare provider right away if you have:

  • weak or shallow breathing
  • severe drowsiness
  • restlessness or you feel agitated or irritable
  • unusual thoughts, hallucinations
  • a light-headed feeling, like you might pass out

Get emergency help right away if you experience shallow or slowed breathing, breathing stops (which may lead to the heart stopping), or excessive sleepiness (sedation).

Abuse, misuse, and addiction

Clobazam is a federally controlled substance (Schedule IV) as it has a risk of abuse, misuse, and addiction, which can lead to overdose or death. Using clobazam more frequently than recommended, even at recommended dosages, may increase these risks, especially when used in combination with other medications (e.g., opioids), alcohol, and/or illicit substances. Talk to your healthcare provider about the signs and symptoms of clobazam addiction.

Dependence and withdrawal reactions

The use of clobazam more frequently than recommended may cause physical dependence. This means that stopping clobazam suddenly can worsen your condition and cause withdrawal symptoms including irritability, sleeplessness, nervousness, and seizures. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

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 clobazam 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 clobazam, 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

Clobazam is present in breast milk. Postmarketing experience suggests that breastfed infants of pregnant people taking benzodiazepines, such as clobazam, may have effects of lethargy, drowsiness (somnolence), and poor sucking. The effect of clobazam on milk production is unknown. 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 clobazam and the potential effect on the infant from clobazam or from your epilepsy.

Effect on birth control and fertility

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

What are the side effects of clobazam?

Common side effects

The most common side effects that were reported in studies of clobazam are constipation, drowsiness (somnolence) or sedation, pyrexia (fever), lethargy, and drooling.

Rare, but serious side effects
Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including clobazam 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 or sedation

Clobazam can make you feel fatigued or drowsy (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how clobazam affects you.

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

Serious dermatological reactions

Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the postmarketing period. You should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment initiation or when re-introducing therapy. Clobazam should be discontinued at the first sign of rash unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, do not continue to use this drug and consider finding an alternative therapy.

Physical and psychological dependence

If you have a history of substance abuse then careful surveillance should be taken when receiving clobazam or other psychotropic agents because of the increased risk of habituation and dependence to the drug.