Ramelteon Pregnancy and Breastfeeding Warnings

Brand names: Rozerem

Medically reviewed by Drugs.com. Last updated on Oct 25, 2023.

Ramelteon Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.

US FDA pregnancy category: C

Comments:
-This drug has been associated with an effect on reproductive hormones, such as decreased testosterone levels and increased prolactin levels.
-It is not known what effect chronic or chronic intermittent use of this drug may have on the reproductive axis in developing humans.

Animal studies have revealed evidence of developmental toxicity and teratogenic effects at doses much greater than the recommended human dose (RHD). Growth retardation, developmental delay, and behavioral changes were observed in animal offspring at doses greater than 30 mg/kg/day; increased incidences of fetal structural abnormalities occurred at doses greater than 40 mg/kg/day; increased incidences of malformation and death among offspring were seen at 300 mg/kg/day. Animal fertility studies show alterations in estrus cyclicity and decreased numbers of corpora lutea, implantations, and live embryos at doses greater than 20 mg/kg/day; no effects on sperm quality or reproductive performance in males were observed. The potential effects of this drug on the duration of labor and/or delivery for either the mother or fetus have not been studied. There are no controlled data in human pregnancy.

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.

See references

Ramelteon Breastfeeding Warnings

In a 6-month study of 122 subjects with chronic insomnia who received 16 mg of this drug once a day, serum prolactin levels increased 34% in women. Thirty-two percent of all patients (both women and men) had prolactin levels that increased 19%.

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: This drug has been associated with an effect on reproductive hormones, such as increased prolactin levels.

See references

Further information

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