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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 Pharmaceutical Company

Therapeutic Use:

Indications for ROZEREM:

Insomnia.

Adult:

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

Children:

Not recommended.

Contraindications:

Concomitant fluvoxamine.

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).

Pharmacological Class:

Hypnotic (melatonin agonist).

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.

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).

How Supplied:

Tabs—30, 100, 500

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