Ramelteon(rah mell’tee on)
Rozerem
PREGNANCY CATEGORY C
Drug Classes
Melatonin receptor agonist
Sedative-hypnotic
Therapeutic Actions
Agonist at melatonin receptor sites believed to contribute to sleep promotion and thought to be involved in the maintenance of circadian rhythm underlying the normal sleep-wake cycle.
Indications
Treatment of insomnia characterized by difficulty with sleep onset
Contraindications and Cautions
Contraindicated with known hypersensitivity to any component of the drug, severe hepatic impairment, concurrent use of fluvoxamine, lactation, severe sleep apnea, severe COPD.
Use cautiously with moderate hepatic impairment, pregnancy.
Available Forms
Tablets—8 mg
Dosages
Adults
8 mg PO taken within 30 min of going to bed.
Pediatric patients
Safety and efficacy not established.
Patients with hepatic impairment
Severe hepatic impairment: Not recommended.
Moderate hepatic impairment: Use with caution.
Concurrent use of CYP1A2 inhibitors (such as ciprofloxacin): Use with caution.
Pharmacokinetics
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