This sheet is about exposure to doxepin in pregnancy and while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare providers.
What is doxepin?
Doxepin is a tricyclic antidepressant that has been used to treat anxiety, depression, and insomnia (trouble sleeping). As a cream (applied topically to the skin), 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 it 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 if they stop taking this medication during pregnancy. If you are thinking about stopping this medication, talk with your healthcare provider first. They may recommend lowering your dose slowly instead of stopping it all at once, since suddenly stopping this medication may cause withdrawal symptoms.
Pregnancy can also change how your body processes this medication. Because of this, some women may need to have their dose adjusted during pregnancy. If needed, your healthcare provider can talk with you about whether any changes to your dose are recommended.
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 of 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. Among one series of 14 pregnancies exposed to doxepin, 1 miscarriage occurred. Because miscarriages can happen for many reasons, it can be hard to know if a medication, the condition being treated, or other factors (such as age, health, or other exposures) caused a miscarriage.
Does taking doxepin increase the chance of birth defects?
Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like doxepin, might increase the chance of birth defects in a pregnancy.
Doxepin has not been well-studied for use in pregnancy. Data from animal studies does not suggest an increased chance of birth defects. In a case series looking at 8 human pregnancies exposed to doxepin, no birth defects were reported. Topical use of doxepin has not been studied, but when the cream is applied to the skin very little is expected to enter the pregnant woman’s bloodstream and reach the fetus.
Does taking doxepin in pregnancy increase the chance of other pregnancy-related problems?
It is not known if doxepin can increase the chance of other pregnancy-related problems, such as preterm delivery (birth before week 37 of pregnancy) or low birth weight (weighing less than 5 pounds, 8 ounces [2,500 grams] at birth).
I need to take doxepin during my pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of some tricyclic antidepressants during pregnancy can cause temporary symptoms in some newborns soon after birth. These symptoms are sometimes referred to as withdrawal and can include jitteriness, vomiting, crying, fussiness, tremors, changes in sleep, trouble feeding, or difficulty regulating body temperature. In most cases, the symptoms are mild and go away on their own within 1 to 2 weeks. 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 exposure to doxepin during pregnancy can affect future behavior or learning for the child. One study looked at 80 children who were exposed to a tricyclic antidepressant during pregnancy, including 1 child who was exposed to doxepin. The study did not find differences in learning or behavior.
Breastfeeding while taking doxepin:
Information on the use of doxepin while breastfeeding is limited. Information on the use of doxepin while breastfeeding is limited. Three case reports suggest that only small amounts of doxepin pass into breast milk. However, in 2 of these reports, babies exposed to doxepin through breast milk had respiratory depression (trouble breathing) and drowsiness (sleepiness). Based on these reports, caution is recommended, especially for infants younger than 10 weeks of age and those born preterm, who may be less able to break down the medication. If you suspect the baby has any symptoms (trouble breathing, not gaining weight, constipation, or is very sleepy), contact the child’s healthcare provider.
The product label for doxepin recommends women who are breastfeeding not use this medication due to a lack of information and because of the potential for serious side effects, including sedation (sleepiness) and respiratory depression (trouble breathing). However, the benefits of using doxepin and breastfeeding might outweigh possible risks. Your healthcare providers can talk with you about using doxepin and what treatment is best for you.
Use of topical doxepin cream is unlikely to pose a risk for a breastfed infant as the amount that enters the milk is thought to be low. Avoid application to the breast to ensure the infant does not come into direct contact with the medication.
If a man takes doxepin, could it affect fertility or increase the chance of birth defects?
It is not known if doxepin could affect fertility (ability to make healthy sperm) or increase the chance of birth defects. In general, exposures that fathers or sperm donors have are less likely 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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