History of angioedema while taking Ramelteon.
Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination
Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia
Pregnancy: Based on animal data may cause fetal harm. Do not use unless the potential benefit justifies the potential risk.
Nursing mothers: Use with caution.
Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment.
Abnormal thinking, behavioral changes, complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes.
Depression: Worsening of depression or suicidal thinking may occur.
CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug.
Reproductive effects: Include decreased testosterone and increased prolactin levels. Effect on the reproductive axis in developing humans is unknown
Patients with severe sleep apnea: Rozerem is not recommended for use in this population.
Pediatric use: Safety and effectiveness not established.
Geriatric use: No overall differences in safety and efficacy between elderly and younger adult subjects.
Hepatic impairment: Is not recommended in patients with severe impairment; use with caution in moderate impairment.
Miscellaneous sedatives & hypnotics
Store at 25°C; excursions permitted to 15° to 30°C. Keep container tightly closed and protected from moisture and humidity.
