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Study Demonstrated Rozerem (ramelteon) Does Not Affect,Middle-of-the-Night Balance in Older Adults with Insomnia

P<0.001, both) -- Immediate memory recall declined significantly with zolpidem (P=0.002)

Adverse events were reported in 13 patients with zolpidem and seven patients during placebo and ROZEREM treatment; none were reported as serious.

About ROZEREM

ROZEREM(TM) (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM is the first and only prescription 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 selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates the sleep-wake cycle.

*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 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, severe COPD, or in children or adolescents. The effects in
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