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Doxepin Pregnancy and Breastfeeding Warnings

Doxepin is also known as: Adapin, Silenor, Sinequan

Medically reviewed on July 28, 2016.

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Sinequan (doxepin)." Roerig Division, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Silenor (doxepin)." Somaxon Pharmaceuticals, San Diego, CA.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Silenor (doxepin)." Somaxon Pharmaceuticals, San Diego, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Sinequan (doxepin)." Roerig Division, New York, NY.
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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