Generic Name and Formulations:
Ramelteon 8mg; tabs.
Takeda Pharmaceutical Company
Indications for ROZEREM:
Take 8mg within 30mins of bedtime. Do not take with high-fat/heavy meals (delays effect).
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).
Hypnotic (melatonin agonist).
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.
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).
Tabs—30, 100, 500
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