New Drug Application Accepted for Lemborexant for Treatment of Insomnia

The Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for lemborexant (Eisai, Woodcliff Lake, NJ). Lemborexant is novel small molecule being investigated for treatment of insomnia. As reported previously in Practical Neurology, patients with insomnia who took lemborexant got to sleep faster, woke in response to auditory stimuli, and returned to sleep effectively after waking. As published in Sleep, people were able to drive safely the morning after taking lemborexant. 

In 2 pivotal phase 3 clinical trials, SUNRISE 1 (NCT02783729) and SUNRISE 2 (NCT0295820), polysomnography and sleep diaries were used to assess the objective and subjective measures of sleep-onset latency, sleep efficiency, and the ability to wake after sleep onset. Over 2,000 patients with insomnia had these measures taking after treatment with lemborexant, zolpidem as a comparator, or placebo. 

Lemborexant is a novel, small-molecule orexin receptor antagonist, thought to affect the sleep-wake cycle by inhibiting wakefulness that is promoted by the orexin.

"Our ultimate goal for the development of a sleep-wake treatment is to bring to patients living with insomnia a new option that has the potential to improve their ability to fall asleep, stay asleep, and wake well the next morning," said Lynn Kramer, MD, chief clinical officer and chief medical officer, Eisai. "This milestone for lemborexant brings us one step closer to addressing unmet needs for millions of patients who experience insomnia."