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New Study Suggests no Significant Impairment in Middle-of-the-Night,Balance, Mobility or Memory in Older Adults Using Ramelteon

SAN DIEGO, May 22, 2007 /PRNewswire/ -- A new study presented today showed that ramelteon did not impair middle-of-the-night balance, mobility or memory performance in older adults with insomnia, relative to placebo. This study also demonstrated, as in previous studies, that patients treated with zolpidem did have impaired performances on these measures, as compared to placebo. The results of this double-blind, placebo-controlled trial were presented in a poster at the American Psychiatric Association 2007 Annual Meeting.

"These data are important because they indicate that ramelteon is a safe sleep medication for patients, especially older adults, concerned about being impaired in the middle of the night," said Gary Zammit, PhD, Director, Sleep Disorders Institute, New York. "Many older adults have concerns about their mobility should they get out of bed in the middle of the night for any reason, such as the need to use the bathroom or even react to an emergency. This study showed that when taking ramelteon, balance and mobility were not significantly affected."

Study Design

A total of 33 adults age 65 or older who suffered from insomnia at least three nights per week for over three months received ramelteon 8 mg, zolpidem 10 mg or placebo 30 minutes before bedtime for one night each in a single- dose, three-period crossover study. Patients were awakened two hours after they were given medication to evaluate standing balance, turning speed and stability, memory and adverse events. The primary endpoint was balance as assessed by NeuroCom EquiTest Sensory Organization Test score (SOT) two hours after dosage.

An SOT protocol objectively identifies abnormalities in patients' use of the three sensory systems that contribute to postural control: somatosensory (perception of sensory stimuli from the skin and internal organs), visual and vestibular (balance system having to do with the audi tory organ). The composite score of each individual sensory test characterizes the overall level of a person's performance.

Results found that compared to placebo, a significant decrease in SOT composite score was observed with zolpidem (P<0.001), but not with ramelteon (P=0.837). Additional results showed:

    * Significant increase in turn time and turn sway versus placebo was seen

      with zolpidem (P<0.001, both), but not with ramelteon (P=0.776, P=0.982,


      respectively).


    * Immediate memory recall declined significantly with zolpidem (P=0.002),

      but not with ramelteon (P=0.683).


    * Adverse events were reported in 13 patients with zolpidem and seven

      patients each during placebo and ramelteon treatment; none were noted as


      serious.


"This study contributes to the growing body of data showing that ramelteon is a safe option for older adults suffering from insomnia characterized by difficulty with sleep onset," said Zammit. "The trial will also help physicians better understand the unique and differentiating mechanism of action of ramelteon and its potential benefits when making appropriate prescribing decisions for their patients."

About Ramelteon

Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Ramelteon can be prescribed for long-term use. Ramelteon 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 ramelteon, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the U.S. Drug Enforcement Administration.

Ramelteon 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 sl eep- wake cycle.

    * Ramelteon is not a controlled substance. A clinical abuse liability

      study showed no differences indicative of abuse potential between

      ramelteon 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 ramelteon compared to placebo

      (N=2082).

Important Safety Information

Ramelteon 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.

Ramelteon has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Avoid taking ramelteon with alcohol. Ramelteon 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. Ramelteon should not be taken with or immediately after a high-fat meal. Ramelteon should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

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

For complete Prescribing Information, visit www.ROZEREM.com.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharm aceutical company in Japan. In the United States, Takeda currently markets products for diabetes, insomnia, wakefulness and gastroenterology. 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 www.tpna.com.

North America, Inc.

CONTACT: Dave Buckalew of Takeda Pharmaceuticals North America,+1-224-554-5486, or Kate Winer of Ketchum, +1-917-301-8406, for TakedaPharmaceuticals North America

Web site: http://www.rozerem.com/http://www.tpna.com/

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