This sheet is about exposure to doxepin in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.
What is doxepin?
Doxepin is a tricyclic antidepressant that has been used to treat alcoholism, anxiety, depression, and insomnia (trouble sleeping). As a cream, it has been used for short-term treatment of itchiness. Some brand names include Quitaxon®, Prudoxin®, Silenor®, Sinequan®, and Zonalon®. It is also sold as a combination drug with another medication called levomenthol under the brand name Doxure®.
Sometimes when women 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. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy. Some women may have a return of their symptoms (relapse) if they stop this medication during pregnancy. If you plan to stop this medication, your healthcare provider may suggest that you slowly lower the dose instead of stopping all at once. Stopping this medication suddenly can cause some people to have withdrawal symptoms.
Pregnancy might affect how some women break down this medication. For this reason, some women might need to have their medication doses changed as a pregnancy progresses. Your healthcare provider can discuss this with you, if needed.
I take doxepin. Can it make it harder for me to get pregnant?
It is not known if doxepin can make it harder to get pregnant.
Does taking doxepin increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. It is not known if taking doxepin increases the chance for miscarriage.
Does taking doxepin 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. Doxepin has not been well-studied with use in pregnancy. Data from animal studies does not suggest an increased chance for birth defects. In a case series looking at 8 human pregnancies, there were no birth defects reported.
Does taking doxepin in pregnancy increase the chance of other pregnancy-related problems?
It is not known if doxepin can cause other 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 doxepin throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of tricyclic antidepressants during pregnancy can cause temporary symptoms in some newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms reported with other tricyclic antidepressant medication have included jitteriness, vomiting, crying, fussiness, changes in sleep patterns, tremors, trouble with eating and/or regulating body temperature. In most cases these symptoms were mild and went away on their own within 1 to 2 weeks after birth. Not all babies exposed to tricyclic antidepressants will have these symptoms. It is not known if taking doxepin during pregnancy would cause similar symptoms in newborns. However, it is important that your healthcare providers know you are taking doxepin so that if symptoms occur your baby can get the care that is best for them.
Does taking doxepin in pregnancy affect future behavior or learning for the child?
It is not known if doxepin increases the chance for behavior or learning issues as this has not been well studied for doxepin. One study looked at 80 children who were exposed to a tricyclic antidepressant medication during pregnancy (only 1 had been exposed to doxepin). This study did not find differences in learning or behavior.
Breastfeeding while taking doxepin:
Doxepin gets into breast milk in small amounts. Information about the use of doxepin while breastfeeding is limited. There are 2 case reports of respiratory depression (trouble breathing) in babies who were exposed to doxepin through breast milk. If you suspect the baby has any symptoms (trouble breathing, not gaining weight, constipation, or is very sleepy), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all of your breastfeeding questions.
If a man takes doxepin, could it affect fertility or increase the chance of birth defects?
It is not known if doxepin could affect a man’s fertility (ability to get a woman pregnant) or increase the chance of birth defects. In general, exposures that men have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
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