Eisai Co., Ltd. announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for lemborexant, its orexin receptor antagonist, intended for treating chronic insomnia in adults.
Lemborexant, a dual orexin receptor antagonist (DORA), targets the orexin neurotransmitter system, which regulates sleep and wakefulness. By competitively binding to orexin receptors OX1R and OX2R, lemborexant is believed to aid in sleep onset and reduce nighttime wakefulness.
Chronic insomnia, affecting 4.7–22.1% of European adults, is characterized by difficulty in falling or staying asleep for at least three months. This condition significantly impacts patients' quality of life, leading to fatigue, concentration issues, and irritability.
Current insomnia treatments in Europe often involve medications that broadly sedate the central nervous system. There is growing demand for alternatives that minimize effects on daytime functioning. If approved, lemborexant could offer a new treatment option for insomnia patients in Europe.
Lemborexant has already been approved for insomnia treatment in over 25 countries, including Japan, the United States, Canada, Australia, and China. Eisai emphasizes neurology, including sleep disorders, as a key therapeutic focus and aims to address unmet medical needs through innovative products.