(Legend)

Generic Name

• Ramelteon [melatonin receptor agonist]
  T½ = 1–2.6 h; M-II metabolite 2–5 h
  Protein binding = 82%
  Pregnancy category C

Trade Name

• Rozerem

Dose Range/Adult Daily Dose

• Adult dose: 8 mg po within 30 min of sleep; do not administer with high-fat meal

Use/Common Side Effects (CSE)

• Use: Insomnia (difficulty with sleep onset)
  CSE: Somnolence, dizziness, nausea, fatigue, headache
  FDA warning: Risk of severe allergic reaction and complex sleep-related behaviors (e.g., sleep-driving)

Geriatric & Dose Considerations

• As with any drug that causes somnolence and dizziness, use with caution

Classification

• Sedative/hypnotic

Assessment Cautions

• Contraindicated: Severe liver disease and fluvoxamine (CYP 1A2 inhibitor). Interactions with rifampin and azole antifungals (ketoconazole). Effect on reproductive hormones in adults (↓ testosterone, ↑ prolactin). Avoid alcohol. In pregnancy, benefit must outweigh risk.
  Report: ↓menses, galactorrhea, ↓ libido, ↓ fertility.