Rozerem™ is indicated for the treatment of insomnia
characterized by difficulty with sleep onset. Rozerem should
not be used in patients with hypersensitivity to ramelteon or
any components of the formulation. Rozerem can be prescribed
for long-term use. However, failure of insomnia to remit after
a reasonable period of time, worsening of insomnia, or the
emergence of new cognitive or behavioral abnormalities after
taking Rozerem should be evaluated, as such symptoms may be
the result of an unrecognized underlying medical disorder. In
primarily depressed patients, worsening of depression,
including suicidal ideation, has been reported in association
with the use of hypnotics.
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.
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.
The most common adverse events seen with Rozerem that had
greater than 2% incidence difference from placebo were
somnolence, dizziness, and fatigue.
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