Doxepin Pregnancy and Breastfeeding Warnings
Brand names: Adapin, Silenor, Sinequan
Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.
Doxepin Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C (tablets)
US FDA pregnancy category: Not formally assigned to a pregnancy category (capsules and oral concentrate)
Comments: Withdrawal symptoms in newborn infants have been reported following prolonged maternal use of tricyclic antidepressants.
Animal studies with the capsule and oral concentrate formulations have failed to reveal evidence of fetal harm; however, evidence exists regarding interference with central monoamine neurotransmission in rats. Animal studies with the tablet formulation have revealed evidence of developmental toxicity, including increased incidences of fetal structural abnormalities and decreased fetal body weights when this drug was administered at higher doses. Decreased pup survival and transient growth delay have also been reported at the highest dose. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Doxepin Breastfeeding Warnings
Use is not recommended.
-According to some authorities: Use is contraindicated.
Excreted into human milk: Yes
Comments:
-Apnea and drowsiness have been reported in the nursing infant.
-If treatment is required in a mother of an older infant, the nursing infant should be monitored carefully for excessive sedation and adequate weight gain.
See also
References for pregnancy information
- (2002) "Product Information. Sinequan (doxepin)." Roerig Division
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2010) "Product Information. Silenor (doxepin)." Somaxon Pharmaceuticals
References for breastfeeding information
- (2002) "Product Information. Sinequan (doxepin)." Roerig Division
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2010) "Product Information. Silenor (doxepin)." Somaxon Pharmaceuticals
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.