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New Study Demonstrates Ramelteon Does Not Exacerbate Respiratory Depressant Effects in Patients With Moderate-to-Severe COPD
Date:12/3/2007

sleep medication that has shown no evidence of abuse or dependence in clinical studies,* and has not been designated as a controlled substance. With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the U.S. Drug Enforcement Administration. ROZEREM has a unique therapeutic mechanism of action that targets MT1 and MT2 receptors. The activity at MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN) is thought to promote sleep.

*ROZEREM is not a controlled substance. A clinical abuse liability study showed no differences indicative of abuse potential between ROZEREM and placebo at doses up to 20 times the recommended dose (N=14). Three 35-day insomnia studies showed no evidence of rebound insomnia or withdrawal symptoms with ROZEREM compared to placebo (N=2082).

Important Safety Information

ROZEREM(TM) should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.

ROZEREM has not been studied in patients with severe sleep apnea or in children or adolescents. The effects in these populations are unknown. Avoid taking ROZEREM with alcohol. Studies for severe COPD have not yet been evaluated by the FDA. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms which could include cessation of menses or galactorrhea in females, decreased libido or problems with fertility that are possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a
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SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2007 PR Newswire.
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