A new study presented 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.”
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 auditory 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.”