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Rozerem Generic Name & Formulations
Legal Class
Rx
General Description
Ramelteon 8mg; tabs.
Pharmacological Class
Hypnotic (melatonin agonist).
How Supplied
Tabs—30, 100, 500
Manufacturer
Rozerem Indications
Indications
Insomnia.
Rozerem Dosage and Administration
Adult
Take 8mg within 30mins of bedtime. Do not take with high-fat/heavy meals (delays effect).
Children
Not recommended.
Rozerem Contraindications
Contraindications
Concomitant fluvoxamine.
Rozerem Boxed Warnings
Not Applicable
Rozerem Warnings/Precautions
Warnings/Precautions
Evaluate for comorbid diagnoses. Depression. Behavioral changes. Monitor prolactin and testosterone levels if unexplained amenorrhea, galactorrhea, decreased libido, or fertility problems occur. COPD, severe obstructive sleep apnea, severe hepatic impairment: not recommended. Moderate hepatic impairment. Pregnancy. Nursing mothers: monitor infants (see full labeling).
Rozerem Pharmacokinetics
See Literature
Rozerem Interactions
Interactions
See Contraindications. Potentiated by strong inhibitors of CYP1A2, CYP3A4 (eg, ketoconazole), CYP2C9 (eg, fluconazole). Antagonized by strong CYP450 inducers (eg, rifampin). Monitor closely with donepezil, doxepin. Avoid alcohol.
Rozerem Adverse Reactions
Adverse Reactions
Somnolence, dizziness, fatigue, nausea, exacerbated insomnia; complex sleep-related behaviors (eg, sleep-driving), reduced testosterone or cortisol levels, increased prolactin levels (monitor if occurs); anaphylaxis, angioedema (do not rechallenge).
Rozerem Clinical Trials
See Literature
Rozerem Note
Not Applicable
Rozerem Patient Counseling
See Literature
