Study demonstrated ROZEREM (ramelteon) does not affect body sway
(20 June 2007: VIDYYA MEDICAL NEWS SERVICE) -- Two studies presented today demonstrated that ROZEREM did not affect body sway at peak plasma levels, nor did it impair middle-of-the-night balance, mobility or memory performance in patients who suffer from chronic insomnia. The results of the studies were presented at the 21st Annual Meeting of the Associated Professional Sleep Societies (APSS).
“These data are important because they show that ROZEREM may be a safe sleep medication for the many older adults who worry about their balance when they need to get up in the middle of the night. These studies also showed that the patients’ memories were not affected by ROZEREM the next morning,” said Gary Zammit, PhD, director, Sleep Disorders Institute, New York.
ROZEREM works differently from other prescription sleep medications. It specifically targets an area of the brain believed to be involved in the regulation of the body’s normal sleep-wake cycle. It is the first prescription sleep medication that is not a controlled substance, and has shown no evidence of abuse or dependence in clinical studies.
ROZEREM Study Design 1: Effect on Body Sway
A total of 275 adults with chronic insomnia received ROZEREM 8 mg, zopiclone 7.5 mg or placebo in a 28-night double-blind treatment period. The primary endpoint was calculated area of center of pressure (COP), in cm2, recorded on the balance platform with eyes open. Zopiclone (Imovane® and Zimovane®) was used as a positive control. On night 14, patients were given a balance test one-and-a-half hours before dosing. Patients were then given their randomized medications and went to sleep. Approximately two hours after they had taken their treatments, the patients were awakened to take the balance test once again.
Results showed that at the time of predicted near-peak plasma levels, the effect of ROZEREM on body sway was no different from placebo. 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 (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.
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