Eszopiclone

The Basics

What is Eszopiclone?

Used in the treatment of insomnia.

Brand names for Eszopiclone

Lunesta

How Eszopiclone is classified

Hypnotics and Sedatives

Eszopiclone During Pregnancy

Eszopiclone pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Eszopiclone while pregnant

Available pharmacovigilance data with LUNESTA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was approximately 200 times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m2 body surface area (See Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) throughout organogenesis showed no evidence of teratogenicity up to the highest doses tested. In rats, reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification were observed at the mid and high doses. The no-observed-effect dose for adverse effects on embryofetal development is 200 times the MRHD of 3 mg/day on a mg/m2 basis. No effects on embryofetal development were observed in rabbits; the highest dose tested is approximately 100 times the MRHD on a mg/m2 basis. Oral administration of eszopiclone (60, 120, or 180 mg/kg/day) to pregnant rats throughout the pregnancy and lactation resulted in increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response at all doses. The lowest dose tested is approximately 200 times the MRHD on a mg/m2 basis. Eszopiclone had no effects on other developmental measures or reproductive function in the offspring.

Taking Eszopiclone While Breastfeeding

What are recommendations for lactation if you're taking Eszopiclone?

Because no information is available on the use of eszopiclone during breastfeeding, an alternate hypnotic may be preferred, especially while nursing a newborn or preterm infant. Data from the racemate, zopiclone, in larger doses indicate that occasional use while breastfeeding an older infant should pose little risk to the infant, but the infant should be monitored for excessive drowsiness.[1]

Maternal / infant drug levels

Because no information is available on the use of eszopiclone during breastfeeding, an alternate hypnotic may be preferred, especially while nursing a newborn or preterm infant. Data from the racemate, zopiclone, in larger doses indicate that occasional use while breastfeeding an older infant should pose little risk to the infant, but the infant should be monitored for excessive drowsiness.[1]

Possible effects of Eszopiclone on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Eszopiclone

Zaleplon, Zolpidem.