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    Home > Medical News > Medical World News > MSD update belsomra label information

    MSD update belsomra label information

    • Last Update: 2020-02-10
    • Source: Internet
    • Author: User
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    Recently, MSD company announced that the US FDA approved it to update the label information of belsomra (suvorexant), reflecting its clinical data in the treatment of insomnia symptoms in patients with mild to moderate Alzheimer's disease Previously, belsomra has been approved for the treatment of insomnia characterized by difficulty sleeping and / or sleep maintenance Insomnia is a sleep disorder that makes it difficult for the patient to fall asleep and / or stay asleep, or causes the patient to get up early There are many factors that can cause insomnia There is evidence that the main reason for this disease is that the signals that promote wakeup in patients are stronger than those that promote sleep in the brain Insomnia is more common in Alzheimer's patients According to the statistics released in the press release, sleep disorders can affect up to 25% of patients with mild to moderate Alzheimer's disease and 50% of patients with severe Alzheimer's disease As the severity of the disease increases, the symptoms tend to worsen Belsomra, a "first in class" orexin receptor antagonist developed by MSD, was approved for marketing in the United States in 2014 to treat insomnia patients Orexin is a neurotransmitter found in specific parts of the brain, which can help people stay awake Source: reference [2] The data that led to the label update came from a four week, randomized, double-blind, placebo-controlled, three-phase clinical trial designed to assess the safety and efficacy of belsomra in the treatment of 285 patients with mild to moderate insomnia with Alzheimer's disease The results showed that compared with placebo group, belsomra significantly improved the total sleep time (TST) and wake-up after sleep (wasO) indexes reference material: [1] Merck Receives Approval for BELSOMRA® (suvorexant) C-IV Label Update to Include Findings from Study of Insomnia in Patients with Mild-to-Moderate Alzheimer’s Disease,Retrieved February 04, 2020, from https:// [2] BELSOMRA Works Differently,Retrieved February 04, 2020, from https:// [3] Merck gets Alzheimer’s label claim for insomnia drug Belsomra,Retrieved February 04, 2020, from https:// Original title: express delivery to improve insomnia symptoms of Alzheimer's disease patients, MSD update drug label Note: the original text has been deleted A kind of
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