Ramelteon: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Ramelteon. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Dizziness | 4% |
| Somnolence | 3% |
| Fatigue | 3% |
| Nausea | 3% |
| Insomnia exacerbated | 3% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see CLINICAL STUDIES (14)].
Medical disclaimer: Always consult a qualified healthcare professional about any medication.