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Ramelteon Pregnancy and Breastfeeding Warnings

Ramelteon is also known as: Rozerem

Ramelteon Pregnancy Warnings

Ramelteon has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when administered in doses 197 times higher than the maximum recommended human dose (MRHD) on a mg/m2 basis. There are no controlled data in human pregnancy. Ramelteon is only recommended for use in during pregnancy when benefit outweighs risk.

When ramelteon was administered orally to both males and females in animal studies prior to and during mating and early gestation, alterations in estrus cyclicity and decreased numbers of corpora lutea, implantations, and live embryos were observed.

Ramelteon Breastfeeding Warnings

There are no data on the excretion of ramelteon into human milk. According to the manufacturer, caution should be exercised when ramelteon is administered to a nursing woman.

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