Rozerem is the first and only prescription
sleep medication that has shown no evidence
of abuse and dependence and, as a result,
has not been designated as a controlled
substance by the DEA. |
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Rozerem Information:
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.
USES: Rozerem is indicated for the
treatment of insomnia characterized by difficulty with
sleep onset.
HOW TO USE: Rozerem should be taken
within 30 minutes before going to bed and activities
should be confined to those necessary to prepare for
bed. Rozerem should not be taken with or immediately
after a high-fat meal. Engaging in hazardous activities
that require concentration (such as operating a motor
vehicle or heavy machinery) after taking Rozerem should
be avoided.
PRECAUTIONS: Rozerem should not be
used by patients with severe hepatic impairment, or
in patients in combination with fluvoxamine. Rozerem
has not been studied in subjects with severe sleep apnea
or severe COPD and is not recommended for use in those
populations. Patients should be advised to exercise
caution if they consume alcohol in combination with
Rozerem. Rozerem has been associated with decreased
testosterone levels and increased prolactin levels.
As a result, healthcare professionals should be mindful
of any unexplained symptoms possibly associated with
such changes in these hormone levels. Rozerem has not
been studied in children or adolescents, and the effects
in these populations are unknown.
SIDE
EFFECTS: The most common adverse events seen
with Rozerem that had greater than 2% incidence difference
from placebo were somnolence, dizziness, and fatigue.
DRUG
INTERACTIONS: Rozerem should not be used in
combination with fluvoxamine.
NOTES:
Do not share this medication with others.
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