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Doxylamine Pregnancy and Breastfeeding Warnings

Doxylamine is also known as: Aldex AN, Aldex AN Chewable, Care One Sleep Aid, Doxytex, Equaline Sleep Aid, Equate Sleep Aid, Fast Sleep, Medi-Sleep, Nighttime Sleepaid, Nytol Maximum Strength, Sleep Aid, Unisom SleepTabs

Medically reviewed on Jan 11, 2018

Doxylamine Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: A
US FDA pregnancy category: Not Assigned

Comments: This drug is not known to cause birth defects, but studies to prove its safety for the developing fetus have not been performed.

See references

Doxylamine Breastfeeding Warnings

Use should be avoided during breastfeeding or if planning to breastfeed.

Excreted into human milk: Yes

Comments: Small occasional doses of this drug would not be expected to cause any adverse effects in breastfed infants; however, larger doses or more prolonged use may cause drowsiness, unusual excitement, or irritability in nursing infants and/or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established.

-In one telephone follow-up study, irritability and colicky symptoms were reported in 10% and drowsiness was reported in 1.6% of infants exposed to various antihistamines; none of the reactions required medical attention.
-Relatively high doses of antihistamines given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women; however, it is unknown whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  2. "Product Information. Unisom (doxylamine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Unisom (doxylamine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. 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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