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Eszopiclone Pregnancy and Breastfeeding Warnings

Eszopiclone is also known as: Lunesta

Medically reviewed on Sep 21, 2018

Eszopiclone Pregnancy Warnings

Animal studies during organogenesis have failed to reveal evidence of teratogenicity. Reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification have been reported at mid to high doses. Increased postimplantation loss, decreased postnatal pup weights and survival, and increased pup startle response were reported to occur at all doses when administered during pregnancy and lactation. There are no controlled data in human pregnancy.

Animal studies have also reported decreased fertility thought to be due to effects in both males and females. No females became pregnant when both males and females were treated with the highest doses. Other effects have been reported to include abnormal estrus cycles, decreases in sperm number and motility, and increases in morphologically abnormal sperm. The no-effect dose for adverse effects on fertility is reported at 16 times the maximum recommended human dose (on a mg/m2 basis).

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.

This drug should be used during pregnancy only if the potential benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Eszopiclone Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation; an alternate hypnotic may be preferred, especially while nursing a newborn or preterm infant.

Excreted into human milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Lunesta (eszopiclone)." Sepracor Inc, Marlborough, MA.

References for breastfeeding information

  1. "Product Information. Lunesta (eszopiclone)." Sepracor Inc, Marlborough, MA.
  2. 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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