Ramelteon

🧮 Dose calculator

Insomnia · Regimen source: FDA Rozerem · 2.1

• • Not with a high-fat meal. Not recommended in severe hepatic impairment. Caution with CYP1A2 inhibitors. FDA Rozerem · 2.1FDA Rozerem · 2.2FDA Rozerem · 2.3

Enter age (weight is optional for this regimen).

👥 Special populations

• 🤰 PregnancyUse with caution

  Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Rozerem · 8.1

  “Risk Summary Available data from postmarketing reports with ROZEREM use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”

• 🤱 BreastfeedingUse with caution

  Label: use with caution while breastfeeding; see the label text. FDA Rozerem · 8.2

  “Risk Summary There are no data regarding the presence of ramelteon or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.”

• 👶 ChildrenSafety not established

  Label: safety and effectiveness in children have not been established. FDA Rozerem · 8.4

  “Safety and effectiveness of ROZEREM in pediatric patients have not been established.”

• 👴 Older adultsNo specific problem stated

  Label: no specific difference or dose adjustment stated for older adults. FDA Rozerem · 8.5

  “No overall differences in safety or efficacy were observed between elderly and younger adult subjects.”

• ⚥ Females & males of reproductive potentialNo data

  The source for this drug has no section for this group.