Monograph Details
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Central Nervous System
> Insomnia
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ROZEREM |
| Manufacturer |
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Takeda Pharmaceuticals America, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Hypnotic (melatonin agonist). |
| Generic Name |
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Ramelteon 8mg; tabs. |
| Indications |
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Insomnia. |
| Children |
Not recommended.
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| Adults |
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Take 8mg within 30min of bedtime. Do not take with high-fat/heavy meals (delays effect). |
| Contraindications |
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Severe hepatic impairment. Concomitant fluvoxamine. |
| Precautions |
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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. |
| Interactions |
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See Contraindications. Avoid alcohol. Potentiated by potent inhibitors of CYP1A2, CYP3A4 (eg, ketoconazole), CYP2C9 (eg, fluconazole). Antagonized by potent CYP450 inducers (eg, rifampin). |
| Adverse Reactions |
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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). |
| How Supplied |
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Tabs—30, 100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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