Clorazepate
Brand Names: Tranxene, generics
Clorazepate (klor AZ e pate) has been approved by the FDA as adjunctive therapy to treat focal seizures.
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 clorazepate? (Available formulations)
Clorazepate is available as a tablet.
Who should not take clorazepate?
If you are allergic to clorazepate or any of the inactive ingredients, then you should not take it.
Other considerations may influence whether you should take clorazepate. Tell your healthcare provider if you:
- have or have had depression, mood problems, or suicidal thoughts or behavior.
- have kidney or liver problems.
- have a history of abnormal thinking and behavior (psychotic reactions).
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
What is important to know about taking clorazepate?
Do not stop taking clorazepate suddenly unless directed to do so by your healthcare provider.
As with all antiseizure medications, clorazepate should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using clorazepate 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 clorazepate 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 or alcohol.
Boxed warning
Clorazepate 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 clorazepate 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
Clorazepate 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 clorazepate, 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
Clorazepate 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 clorazepate 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 lorazepam addiction.
Dependence and withdrawal reactions
The use of clorazepate more frequently than recommended may cause physical dependence. This means that stopping clorazepate 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 clorazepate in pregnant people. An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. 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 clorazepate, 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
Clorazepate is present in breast milk and should not be given to nursing people since it has been reported that nordiazepam is excreted in human breast milk. It is unknown if there are effects on the breastfed infant, or if clorazepate 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 clorazepate and the potential effect on the infant from clorazepate or from your epilepsy.
What are the side effects of clorazepate?
Common side effects
The most common side effects that were reported in studies of clorazepate are drowsiness, dizziness, upset stomach, blurred vision, and dry mouth.
Rare, but serious side effects
Suicidal thoughts or behaviors
Studies have found that people who take antiseizure medications including clorazepate 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.
Interference with psychomotor performance
Clorazepate can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clorazepate affects you.
Use with central nervous system depressants
When taken with alcohol or drugs that cause sleepiness or dizziness, clorazepate may make your sleepiness or dizziness much worse. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clorazepate dipotassium tablets without first talking to your healthcare provider.
Do not drive or operate machinery until you have gained sufficient experience on clorazepate to gauge whether it adversely affects your abilities.
Use in depressive neuroses or psychotic reactions
Clorazepate is not recommended for use in depressive neuroses (constant sad mood) or in psychotic reactions.