/PRNewswire/ As reported in the Lancet Neurology, daridorexant is the first insomnia medication to demonstrate an effect of a drug therapy to improve both.
to promote wakefulness.16 Under normal circumstances, orexin levels rise throughout the day as wakefulness is promoted and then fall at night.13 Overactivity of the wake system is an important driver. | January 20, 2022
for the treatment of adult patients with insomnia
• The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favorable safety profile
Allschwil, Switzerland - March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia.
Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on a
Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia
Allschwil, Switzerland - March 10, 2021
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia.
Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.
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