Results of a sub-analysis from a Phase III clinical study showed that ROZEREMTM (ramelteon) significantly reduced time to fall asleep in adults with chronic insomnia and showed no evidence of rebound insomnia or withdrawal effects. The results were presented today at the 2006 Annual Meeting of the American Academy of Neurology.

In this placebo-controlled analysis, approximately two-thirds of patients who received 8 mg of ROZEREM experienced at least a 50 percent reduction in the time it took them to fall asleep. Study participants also experienced no rebound insomnia or withdrawal effects following discontinuation of treatment with ROZEREM. Rebound insomnia is the worsening of insomnia symptoms after a person stops taking their insomnia medications.

"These data show that ROZEREM can be effective in helping patients fall asleep faster without rebound insomnia and other withdrawal effects," said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit, Mich. "This may represent another option for patients who are looking for a sleeping medication that is right for them."

About the Study
In this sub-analysis of a large, double-blind, placebo-controlled study, a total of 269 adults received 8 mg of ROZEREMTM (n=138) or placebo (n=131) nightly for five weeks (35 nights). Sleep parameters were evaluated at weeks 1, 3, and 5 by using a polysomnograph. ROZEREM was replaced with placebo for the two nights following the study (nights 36 and 37) to evaluate rebound insomnia and withdrawal effects.

The primary endpoint was the percentage of patients who achieved at least 50 percent improvement in the time it took to fall asleep (latency to persistent sleep, or LPS).

Results showed that a statistically significantly greater percentage of adults with chronic insomnia treated with ROZEREM 8 mg demonstrated at least 50 percent LPS reduction compared to those who received placebo at week 1 (63 percent vs. 40 percent (P ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence in clinical studies,* and as a result, 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 24-hour, or circadian rhythms, including the sleep-wake cycle.

The FDA approved ROZEREM in July 2005 for the treatment of insomnia, characterized by difficulty with sleep onset. It is approved for long-term use in adults.

*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).

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Important Safety Information
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. 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 these populations are unknown. Exercise caution if consuming alcohol in combination with ROZEREM.

ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal. ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

The most common adverse events seen with ROZEREM that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.

For complete prescribing information, please visit rozerem/.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust, pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit tpna/.

Contact: David Buckalew
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