Class
Melatonin receptor agonist
Mechanism
Selective agonist at MT1 and MT2 melatonin receptors, promoting sleep onset regulation
FDA-Approved Use
Insomnia characterized by difficulty with sleep onset
Off-Label Use
None well established
Formulation
Oral tablets
Titration
8 mg p.o. nightly, taken within 30 minutes of bedtime; avoid high-fat meals close to dosing
Dose Range
8 mg/day
Kinetics
Rapid absorption with a short half-life; minimal drug interactions
Common AEs
Dizziness, fatigue, somnolence
Serious/Rare AEs
Rare reports of worsening depression or suicidal ideation; monitor mood changes
Monitoring
Monitor for mood changes and unusual sleep behaviors
Black Box Warning
None
Considerations
Ramelteon is well tolerated in elderly patients and may be preferred for insomnia due to its minimal risk of dependence, absence of withdrawal symptoms, and limited next-day sedation