Sleep-wake disorders:

Indications for: ROZEREM


Adult Dosage:

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

Children Dosage:

Not recommended.

ROZEREM Contraindications:

Concomitant fluvoxamine.

ROZEREM 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).

ROZEREM Classification:

Hypnotic (melatonin agonist).

ROZEREM 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