Temazepam (Restoril®)
This sheet is about exposure to temazepam in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is temazepam?
Temazepam is a medication that has been used to treat insomnia (having a hard time falling asleep or staying asleep). Temazepam is in a class of medications called benzodiazepines. It is sold under the brand name Restoril®.
Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. If you take this medication regularly and then suddenly stop taking it (called “cold turkey”), you could have withdrawal symptoms. It is not known what effects, if any, withdrawal could have on a pregnancy.
The product label for temazepam recommends people who are pregnant not use this medication during pregnancy. This is because there is concern based on the use of other medications like temazepam. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
I take temazepam. Can it make it harder for me to get pregnant?
It is not known if using temazepam could make it harder to get pregnant.
Does taking temazepam increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if temazepam could increase the chance of miscarriage.
Does taking temazepam increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Experimental animal studies did not find a higher chance for birth defects with exposure to temazepam. There was no increase in the chance for birth defects in one study involving 379 children exposed to temazepam during the first trimester of pregnancy.
Does taking temazepam in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if temazepam increases the chance for pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).
I need to take temazepam throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of a benzodiazepine near the time of delivery could cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms can include irritability, crying, sleep disturbances, tremors, jitteriness, trouble breathing, or muscle weakness. Not all babies exposed to a benzodiazepine will have symptoms. It is not known if the use of temazepam in pregnancy can cause symptoms in a newborn. It is important that your healthcare providers know you are taking temazepam so that if symptoms occur your baby can get the care that is best for them.
Can I take my benzodiazepine with diphenhydramine?
A single human report and animal data have suggested that the combination of temazepam and diphenhydramine (Benadryl®) might increase the chance for stillbirth or for infant death shortly after birth. People taking temazepam should talk with their healthcare provider before taking diphenhydramine during their pregnancy. MotherToBaby has a fact sheet on diphenhydramine here: https://mothertobaby.org/fact-sheets/diphenhydramine-pregnancy/.
Does taking temazepam in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if temazepam can cause behavior or learning issues for the child.
Breastfeeding while taking temazepam:
Temazepam has not been well studied for use while breastfeeding. When given in a single intravenous (IV) dose, only small amounts of temazepam get into breast milk. No side effects were reported in 13 infants who were exposed to temazepam through breast milk. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes temazepam, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done to see if temazepam could affect male fertility or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
MotherToBaby | Fact Sheets [Internet]. Organization of Teratology Information Specialists (OTIS). Copyright by OTIS, January 2023.