Generic Name and Formulations:
Ramelteon 8mg; tabs.
Takeda Pharmaceuticals USA, Inc.
Indications for ROZEREM:
Take 8mg within 30min of bedtime. Do not take with high-fat/heavy meals (delays effect).
Severe hepatic impairment. Concomitant fluvoxamine.
Severe COPD, severe obstructive sleep apnea: not recommended. Moderate hepatic impairment. Depression. Behavioral changes. Monitor prolactin and testosterone levels if unexplained amenorrhea, galactorrhea, decreased libido, or fertility problems occur. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. Avoid alcohol. Potentiated by potent inhibitors of CYP1A2, CYP3A4 (eg, ketoconazole), CYP2C9 (eg, fluconazole). Antagonized by potent CYP450 inducers (eg, rifampin).
Hypnotic (melatonin agonist).
Somnolence, complex sleep-related behaviors (eg, sleep-driving), dizziness, fatigue; reduced testosterone or cortisol levels, increased prolactin levels (monitor if occurs); anaphylaxis, angioedema, others (see literature).
Tabs—30, 100, 500
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