Silenor

THE SAFETY OF DOXEPIN (SILENOR) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION MAY CAUSE HARM TO YOUR BABY:

Limited information is available on the safety of doxepin during pregnancy. However, doxepin has not been associated with birth defects during pregnancy. Doxepin can cause breathing difficulties and poor feeding if used when breastfeeding an infant, so it should be avoided in women who are nursing.

What is doxepin?

Doxepin is a tricyclic antidepressant.

What is doxepin used to treat?

Doxepin is a prescription medication used to treat insomnia and difficulty staying asleep.

How does doxepin work?

Doxepin increases the presence of the neurotransmitters serotonin and norepinephrine in the brain. Doxepin also blocks histamine type 1 receptors, which increases sleepiness.

If I am taking doxepin, can it harm my baby?

Little safety information is available on doxepin. Studies in animals suggest doxepin may be toxic to the developing baby and may increase the risk of low birth weight. Doxepin is thought to have a low risk for birth defects. One case report described decreased intestinal motility and resulting gastrointestinal obstruction.

If I am taking doxepin and become pregnant, what should I do?

The risks should be weighed against the benefits of continuing doxepin during pregnancy. Women who are attempting to conceive or become pregnant while on doxepin should speak with their doctor. Other medications may be preferred over doxepin during pregnancy. 

If I am taking doxepin, can I safely breastfeed my baby?

Doxepin passes into the breast milk. Nursing infants exposed to doxepin in breast milk can experience sleepiness, breathing difficulties, poor swallowing, vomiting, muscle weakness, and poor feeding. These symptoms will decrease over a 24 hour period if breastfeeding is discontinued. If women continue to breastfeed while on doxepin, infants should be monitored for excessive sleepiness and below normal weight gain. Exercise caution if administering doxepin to women who are breastfeeding infants. It is recommended to avoid doxepin use when breastfeeding. The American Academy of Pediatrics classifies doxepin as a possible concern.

If I am taking doxepin, will it be more difficult to get pregnant?

Based on results from animal studies, doxepin may adversely affect fertility in both men and women.

If I am taking doxepin, what should I know?

It is important to speak with your doctor to determine if you should be on doxepin therapy during pregnancy. Doxepin should only be used during pregnancy if the benefits to the mother outweigh the risks to the developing baby. Doxepin exposure through breast milk in nursing infants has been associated with reports of breathing difficulties, poor feeding, and muscle weakness. Breastfeeding mothers who are taking doxepin should monitor their baby for any adverse effects.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of doxepin during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about insomnia here,  and reports about the individual medications used to treat mental health conditions here.   Additional information can also be found in the resources below. 

For more information about doxepin during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Silenor.com:  Silenor Prescribing Information

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.