Clobazam

The Basics

What is Clobazam?

Used with other medication(s) to control seizures in adults and children 2+ who have Lennox-Gastaut syndrome.

Brand names for Clobazam

Onfi

How Clobazam is classified

Anticonvulsants, Benzodiazepines

Clobazam During Pregnancy

Clobazam pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Clobazam while pregnant

There are no adequate and well-controlled studies of ONFI in pregnant women. Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies. Although some early epidemiological studies suggested a relationship between benzodiazepine drug use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations. More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies. There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment. There are clinical considerations regarding exposure to benzodiazepines during the second and third trimester of pregnancy or immediately prior to or during childbirth. These risks include decreased fetal movement and/or fetal heart rate variability, “floppy infant syndrome,” dependence, and withdrawal [see Clinical Considerations and Human Data]. Administration of clobazam to pregnant rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation resulted in developmental toxicity, including increased incidences of fetal malformations and mortality, at plasma exposures for clobazam and its major active metabolite, N-desmethylclobazam, below those expected at therapeutic doses in patients [see Animal Data]. Data for other benzodiazepines suggest the possibility of long-term effects on neurobehavioral and immunological function in animals following prenatal exposure to benzodiazepines at clinically relevant doses. ONFI should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Advise a pregnant woman and women of childbearing age of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Fetal/Neonatal Adverse Reactions Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period. Clinical manifestations of withdrawal or neonatal abstinence syndrome may include hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, and vomiting. These complications can appear shortly after delivery to 3 weeks after birth and persist from hours to several months depending on the degree of dependence and the pharmacokinetic profile of the benzodiazepine. Symptoms may be mild and transient or severe. Standard management for neonatal withdrawal syndrome has not yet been defined. Observe newborns who are exposed to ONFI in utero during the later stages of pregnancy for symptoms of withdrawal and manage accordingly.

Taking Clobazam While Breastfeeding

What are recommendations for lactation if you're taking Clobazam?

Limited information indicates that maternal doses of clobazam up to 30 mg daily produce low levels in milk. Short-term use would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. During long-term administration, monitor the infant for possible sedation and poor sucking and weight gain.[1][2]

Maternal / infant drug levels

Limited information indicates that maternal doses of clobazam up to 30 mg daily produce low levels in milk. Short-term use would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. During long-term administration, monitor the infant for possible sedation and poor sucking and weight gain.[1][2]

Possible effects of Clobazam on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Clobazam

None listed