Eisai's Insomnia Drug Lemborexant Undergoing EMA Review
Eisai Co., Ltd. announced that the European Medicines Agency (EMA) has accepted for evaluation a marketing authorization application for its in-house developed insomnia drug, lemborexant.
Tokyo – Eisai Co., Ltd. announced on July 17, 2026, that the European Medicines Agency (EMA) has accepted for evaluation a marketing authorization application (MAA) for lemborexant, an orexin receptor antagonist discovered and developed in-house.
The application seeks approval for lemborexant for the treatment of adult patients suffering from chronic insomnia. Lemborexant functions as a dual orexin receptor antagonist (DORA), inhibiting the orexin neurotransmission system that regulates sleep and wakefulness. By competitively binding to the two subtypes of orexin receptors (OX1R and OX2R), it is believed to facilitate sleep onset and decrease wakefulness.
Chronic insomnia impacts an estimated 4.7–22.1% of adults in Europe, leading to significant reductions in quality of life and daily functioning. Current insomnia treatments in Europe often involve broad central nervous system depressants. Lemborexant's mechanism offers a potential new therapeutic option that may address the need for treatments that also consider daytime functioning.
Eisai identifies neurology, including sleep disorders, as a key therapeutic area and is committed to delivering innovative products to address unmet medical needs. The company aims to increase benefits for patients living with neurological diseases and their families.