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New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia
Date:8/31/2007

CAIRNS, Australia, Aug. 31 /PRNewswire/ --

What and When

Data from a six-month study of ramelteon will be presented in poster format at worldsleep07: The 5th World Congress of the World Federation of Sleep Research and Sleep Medicine Societies to be held in Cairns, Australia September 2-6, 2007. This large clinical study demonstrated that ramelteon was effective in reducing time to fall asleep for up to six months versus placebo in adult patients with chronic insomnia.

A total of 451 patients age 18 or older with chronic insomnia were randomized in this clinical study. Patients were given a nighttime dose of ramelteon 8 mg or placebo for up to 24 consecutive weeks with assessments performed after week one and months one, three, five and six of treatment.

Study results revealed consistent and statistically significant improvements in time to sleep onset using objective assessment via polysomnography -- a test that records brain activity and other body functions during sleep. Long-term use of ramelteon 8 mg was well tolerated and showed no evidence of next-day residual effects, pharmacological tolerance, rebound insomnia or withdrawal symptoms.

Poster 525 will be presented on Monday, September 3, 4:00 - 6:00 p.m.

Australian Eastern Standard Time To arrange an interview with Steven Sainati, please contact Amy Losak at

646-935-3917

Ramelteon is marketed by Takeda Pharmaceuticals North America, Inc. in the United States as ROZEREM(TM)(ramelteon).

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 me
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SOURCE Takeda Pharmaceuticals North America, Inc.
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