ROZEREM DRUG INFO

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

RAMELTION

COMMON BRAND NAME(S): Rozerem

WARNING: Don’t take Rozerem if you’re taking LUVOX® (fluvoxamine) or have severe liver problems. Avoid taking it with alcohol. Don’t drive or operate machinery until you know how you’ll react to Rozerem. Rozerem may affect testosterone and prolactin. Consult your doctor if you have concerns about a change in your period, libido, fertility, or if your insomnia doesn’t improve. Take Rozerem right before bed. Side effects may include drowsiness, fatigue, and dizziness.

DOSAGE AND ADMINISTRATION: The recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
ROZEREM should not be used in subjects with severe hepatic impairment.
ROZEREM should be used with caution in patients with moderate hepatic
impairment.
ROZEREM should not be used in combination with fluvoxamine. ROZEREM
should be used with caution in patients taking other CYP1A2 inhibiting drugs
(see PRECAUTIONS: Drug Interactions).

PRECAUTIONS: ROZEREM has not been studied in subjects with severe sleep apnea or severeCOPD and is not recommended for use in those populations. Patients should be advised to exercise caution if they consume alcohol incombination with ROZEREM. Use in Adolescents and Children
ROZEREM has been associated with an effect on reproductive hormones in
adults, e.g., decreased testosterone levels and increased prolactin levels. It is not known what effect chronic or even chronic intermittent use of ROZEREM may have on the reproductive axis in developing humans (see Pediatric Use). Information for Patients
• Patients should be advised to take ROZEREM within 30 minutes prior to
going to bed and should confine their activities to those necessary to
prepare for bed.
• Patients should be advised to avoid engaging in hazardous activities (such
as operating a motor vehicle or heavy machinery) after taking ROZEREM.
• Patients should be advised that they should not take ROZEREM with or
immediately after a high-fat meal.
• Patients should be advised to consult their health care provider if they
experience worsening of insomnia or any new behavioral signs or
symptoms of concern.
• Patients should consult their health care provider if they experience one of
the following: cessation of menses or galactorrhea in females, decreased
libido, or problems with fertility. 

DRUG INTERACTIONS: Tell your doctor of all over-the-counter and prescription medication you may use. Do not start or stop any medicine without a doctor or pharmacist's approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES: Do not share this drug with others.

STORAGE: Store at room temperature away from sunlight and moisture.