Sleep-wake disorders:
Indications for: ROZEREM
Insomnia.
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
