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ROZEREM
Sleep-wake disorders
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Drug Name:

ROZEREM Rx

Generic Name and Formulations:
Ramelteon 8mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.

Therapeutic Use:

Indications for ROZEREM:

Insomnia.

Adult:

Take 8mg within 30min of bedtime. Do not take with high-fat/heavy meals (delays effect).

Children:

Not recommended.

Contraindications:

Severe hepatic impairment. Concomitant fluvoxamine.

Warnings/Precautions:

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:

See Contraindications. Avoid alcohol. Potentiated by potent inhibitors of CYP1A2, CYP3A4 (eg, ketoconazole), CYP2C9 (eg, fluconazole). Antagonized by potent CYP450 inducers (eg, rifampin).

Pharmacological Class:

Hypnotic (melatonin agonist).

Adverse Reactions:

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:

Tabs—30, 100, 500

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