Sleep Links

The links below will take you to Web sites that are operated by independent third parties.

National Sleep Foundation
http://www.rozerem.com/SleepLinks.aspx#

American Board of Sleep Medicine
http://www.rozerem.com/SleepLinks.aspx#

National Academy of Sciences
http://www.rozerem.com/SleepLinks.aspx#

AASM, American Academy of Sleep Medicine
http://www.rozerem.com/SleepLinks.aspx#

The Better Sleep Council
http://www.rozerem.com/SleepLinks.aspx#

Associated Professional Sleep Societies, LLC (APSS)
http://www.rozerem.com/SleepLinks.aspx#

American Psychiatric Association
http://www.rozerem.com/SleepLinks.aspx#

American Academy of Neurology (AAN)
http://www.rozerem.com/SleepLinks.aspx#

American Geriatrics Society (AGS)
http://www.rozerem.com/SleepLinks.aspx#



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.




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