Medication Guide App

Eszopiclone Pregnancy and Breastfeeding Warnings

Eszopiclone is also known as: Lunesta

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

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 Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)