2020-02-03
Dayvigo (lembroexant) developed by Eisai is an orexin receptor antagonist. Orexin is a neuropeptide secreted by the hypothalamus and plays an important role in maintaining arousal. By blocking the interaction of orexin A and orexin B with orexin receptor 1 (OXR1) and orexin receptor 2 (OXR2), Dayvigo can inhibit arousal and thus treat various symptoms of insomnia. Because Dayvigo's brain region is more specific than other drugs for insomnia, it has fewer side effects.
The approval is based on the results of two key Phase 3 studies (SUNRISE 2 and SUNRISE 1) that evaluated Dayvigo's efficacy in a total of approximately 2,000 adult patients with insomnia compared to the control group and placebo. The results of these studies indicate that Dayvigo shows a statistically significant advantage in both subjective and objective evaluations in terms of falling asleep and sleep maintenance compared to placebo.