Lemborexant is a small molecule sleep-wake regulation agent discovered and developed by Eisai scientists. Credit: Alyssa L. Miller.

Eisai and its partner Purdue Pharma have submitted new drug application to the US Food and Drug Administration (FDA) seeking approval for lemborexant to treat insomnia, a sleep disorder.

Lemborexant is an investigational, small molecule designed to act on the orexin neurotransmitter system for sleep-wake regulation by suppressing wakefulness without affecting the ability to awaken to external stimuli.

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Eisai and Purdue Pharma are jointly developing the drug for the treatment of various sleep-wake disorders, such as insomnia.

The application submitted to the FDA includes findings from two pivotal Phase III clinical trials, SUNRISE 1 and SUNRISE 2, conducted in a total of nearly 2,000 insomnia patients.

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group trial, SUNRISE 1 assessed the safety and efficacy of lemborexant in 1,006 adults aged 55 years and above at clinical sites in North America and Europe.

The primary objective of the trial was to establish superiority of either 5mg or 10mg lemborexant over placebo on objective sleep onset, after one month of treatment.

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“Lemborexant is an investigational, small molecule designed to act on the orexin neurotransmitter system for sleep-wake regulation by suppressing wakefulness without affecting the ability to awaken to external stimuli.”

SUNRISE 2 was a 12-month multi-centre, global, randomised, controlled, double-blind, parallel-group trail investigating the efficacy and safety of lemborexant in 949 adults aged 18-88 years.

The study’s primary objective was the efficacy of 5mg and 10mg lemborexant on patient-reported (subjective) sleep onset latency, compared to placebo after six months of treatment.

In addition, the application is based on data obtained during safety studies, including evaluation of postural stability following middle-of-the-night awakening and a next-morning driving study.

Eisai and Purdue Pharma are currently studying the drug in a Phase II trial with patients suffering from irregular sleep-wake rhythm disorder and mild to moderate Alzheimer’s dementia.