Of note, Eisai and Purdue Pharma will present data on a Phase I safety study that assessed the ability to awaken to an auditory stimulus and maintain balance (a predictor of risk for falls) and perform on tests of memory and attention in the middle of the night and the next morning. The study demonstrated that balance was statistically significantly worse for zolpidem ER 6.25 mg compared with both lemborexant 5 mg and 10 mg in healthy volunteers age 55 and older, and the primary endpoint
was achieved. In this study, headache was the only adverse event (AE) observed in two or more people taking lemborexant.
Another Phase I study, which evaluated next-morning effects via an on-road driving test, also achieved its primary objective, demonstrating no significant difference in next-morning driving performance versus placebo. This study was conducted versus placebo, with zopiclone included as a positive control, to evaluate potential next-morning impairment by measuring healthy adult and elderly participants’ driving performance. In this study, the most common AEs observed in the lemborexant were drowsiness, headache, and dry mouth.
“It is important that a treatment for sleep/wake regulation allows a patient to not only sleep well, but also wake well. Sleeping well includes the ability to fall asleep and stay asleep through the night, and waking well includes the ability to wake in the middle of the night, if needed, or the next day without impairment,” said Russell Rosenberg, PhD, D.ABSM, NeuroTrials CEO, principal investigator, and former Chairman of the Board of the National Sleep Foundation. “These studies provide important information about how lemborexant affects the ability to awaken after sleep.”
Thank you to all our volunteers who participated! We are moving insomnia research forward.