Patients Treated With Lemborexant Awake and Return to Sleep Safely Without Fall Risk
In results presented today at the Associated Professional Sleep Societies meeting (SLEEP 2018, Baltimore, MD) it was shown that patients treated with lemborexant (Eisai, Woodcliff Lake, NJ and Purdue Pharma, Stamford, CT) can awaken safely, without increasing body sway, after 4 hours of sleep and then are able to return to sleep. Body sway is a measure of postural stability that is a predictor of falls. Data presented suggest that lemborexant is a sleep aid that allows people to wake when they need to, function safely as needed, and then return to sleep as quickly as they did before awakening. Eisai and Purdue Pharma hope to file a new drug application with the Food and Drug Administration (FDA) in Eisai’s FY 2018 and report that they are on track to meet that schedule.
Healthy volunteers, age ³55, were given placebo, zolpidem (6.25 mg), or lemborexant (5 mg or 10 mg), and awoken after 4 hours of sleep by an auditory stimulus (noise). Upon becoming fully awake, body sway scores were measured. On this scale, a change of 7 units is clinically significant as benchmarked by the effect of alcohol.
When given lemborexant and awoken after 4 hours of sleep, body sway scores changed by a mean of 5.8 units (5 mg) and 8.1 units (10 mg) compared to -1.1 units for placebo, and 20.8 units for zolpidem. The differences between both doses of lemborexant and zolpidem were statistically significant (P = .0001). Upon awakening the next morning, body sway scores for persons given lemborexant were not statistically different from scores of those given placebo (P = .01). In a separate study, the ability of persons given lemborexant to drive safely (as measured by a standardized test of weaving) was not statistically different from the ability of those given a placebo.
“Postural instability is thought to be the single best predictor of falls. Significant unmet need exists for a treatment that can help people awaken in the night or the next morning without this type of impairment,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.
Lemborexant is a dual orexin receptor antagonist in phase 3 development, although data presented are from phase 1 studies 108 and 106, respectively. Unlike other sleep aids, it suppresses the stimulatory wake phase of the sleep-wake cycle rather than promoting the sedative sleep phase. No serious or severe adverse effects were reported after any treatment in either study, and the most common adverse events in the lemborexant groups were somnolence (study 106), headache (both studies), and dry mouth (study 106).
“Sleep medications should not only improve the ability to sleep through the night, but also allow patients to awaken in the middle of the night, if needed, and to function upon awakening,” said Marcelo Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma. “We are pleased to share these study results and are committed to exploring the value of lemborexant in specific unmet needs of patients with sleep disorders.”
Russell Rosenberg, MD, Principal Investigator for the studies noted, “Seeing patients with insomnia every day and every week, I know this will be a nice tool for the clinician to have to help those patients when it is available.”