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

. However, the positive control, zopiclone, did show a statistically significant difference versus placebo at near-peak plasma levels, indicating impairment in body sway. Specific findings showed that the mean log of COP post-dose for placebo was 1.617 cm2 and for ROZEREM 1.497 cm2, (P=0.532). For zopiclone the mean log of COP after dosage was 3.539 cm2, (P<0.001) compared to placebo.

ROZEREM Study Design 2: Middle-of-the-Night Balance, Mobility or Memory Performance

This study evaluated the effects of ROZEREM versus placebo on middle-of- the-night balance, mobility and memory performance in older adults with chronic insomnia, with zolpidem as a positive control. A total of 33 adults age 65 or older with chronic insomnia received ROZEREM 8 mg, zolpidem 10 mg or placebo 30 minutes before bedtime for one night each in this double-blind, placebo-controlled 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 (SOT) score two hours after dosage. An SOT objectively identifies abnormalities in patients' use of the three sensory systems that contribute to postural control.

Results found that compared to placebo, ROZEREM did not impair middle-of- the-night balance, mobility or memory performance in older adults with chronic insomnia, relative to the positive control zolpidem. A significant decrease in mean SOT composite score was observed between zolpidem and placebo (P<0.001), but not between ROZEREM and placebo (P=0.837). As compared to placebo, ROZEREM results showed:

    -- No significant increase in turn time and turn sway (P=0.776, P=0.982,

       respectively)

    -- Immediate memory recall did not decline significantly (P=0.683)


    As compared to placebo, zolpidem results showed:


    -- Significant increase in turn time and turn sway (
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