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.
References:
1. Turek FW, Dugovic C, Zee PC. Current understanding of
the circadian clock and the clinical implications for neurological
disorders. Arch Neurol. 2001;58:1781-1787.
2. Edgar DM, Dement WC, Fuller CA. Effect of SCN
lesions on sleep in squirrel monkeys: evidence for opponent
processes in sleep-wake regulation. J Neurosci.
1993;13:1065-1079. 3. Roth T, Roehrs T.
Insomnia: epidemiology, characteristics, and consequences. Clin
Cornerstone. 2003;5:5-15.
