Ramelteon does not impair middle-of-the-night balance, mobility or memory performance in older adults with insomnia compared with placebo, according to a presentation at the annual meeting of the American Psychiatric Association.

“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 years or older who had 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.

Researchers found that compared to placebo, a significant decrease in composite score was observed with zolpidem, but not with ramelteon. In addition, there was a significant increase in turn time and turn sway versus placebo with zolpidem, but not with ramelteon.

Immediate memory recall declined significantly with zolpidem, but not with ramelteon. 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.”