Ramelteon

The Basics

What is Ramelteon?

Used to help patients who have sleep-onset insomnia fall asleep more quickly.

Brand names for Ramelteon

Rozerem

How Ramelteon is classified

Central Nervous System Depressants

Ramelteon During Pregnancy

Ramelteon pregnancy category

Category CNote 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 Ramelteon while pregnant

In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses much greater than the recommended human dose (RHD) of 8 mg/day. There are no adequate and well-controlled studies in pregnant women. ROZEREM (ramelteon) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of ramelteon (10, 40, 150 or 600 mg/kg/day) to pregnant rats during the period of organogenesis was associated with increased incidences of fetal structural abnormalities (malformations and variations) at doses greater than 40 mg/kg/day. The no-effect dose is approximately 50 times the RHD on a body surface area (mg/m²) basis. Treatment of pregnant rabbits during the period of organogenesis produced no evidence of embryo-fetal toxicity at oral doses of up to 300 mg/kg/day (or up to 720 times the RHD on a mg/m² basis. When rats were orally administered ramelteon (30, 100, or 300 mg/kg/day) throughout gestation and lactation, growth retardation, developmental delay, and behavioral changes were observed in the offspring at doses greater than 30 mg/kg/day. The no-effect dose is 36 times the RHD on a mg/m² basis. Increased incidences of malformation and death among offspring were seen at the highest dose.

Taking Ramelteon While Breastfeeding

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

No information is available on the use of ramelteon during breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the use of ramelteon during breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Ramelteon on milk supply

Prolactin levels increased by 4.9 mcg/L (34%) in non-breastfeeding women with chronic insomnia who were taking ramelteon 16 mg nightly for 6 months. No clinical symptoms of hyperprolactinemia were reported.[1] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Ramelteon

None listed