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LUNESTA (ESZOPICLONE): SPECIAL POPULATIONS

Pregnancy

Pregnancy Category C

Lunesta (Eszopiclone) tablets administered by oral gavage to pregnant rats and rabbits during the period of organogenesis showed no evidence of teratogenicity up to the highest doses tested (250 and 16 mg/kg/day in rats and rabbits, respectively; these doses are 800 and 100 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). In the rat, slight reductions in fetal weight and evidence of developmental delay were seen at maternally toxic doses of 125 and 150 mg/kg/day, but not at 62.5 mg/kg/day (200 times the MRHD on a mg/m2 basis).

Eszopiclone (Lunesta) was also administered by oral gavage to pregnant rats throughout the pregnancy and lactation periods at doses of up to 180 mg/kg/day. Increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response were seen at all doses; the lowest dose tested, 60 mg/kg/day, is 200 times the MRHD on a mg/m2 basis. These doses did not produce significant maternal toxicity. Eszopiclone had no effects on other behavioral measures or reproductive function in the offspring.

There are no adequate and well-controlled studies of eszopiclone in pregnant women. Lunesta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Lunesta (Eszopiclone) has no established use in labor and delivery.

Nursing Mothers

It is not known whether Eszopiclone (Lunesta) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this medication is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of eszopiclone in children below the age of 18 have not been established.

Geriatric Use

A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg Eszopiclone (Lunesta) tablets was not different from that seen in younger adults. Lunesta 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population.

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