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    Home > Active Ingredient News > Drugs Articles > FDA approved the first sleeping pill for midnight wakes

    FDA approved the first sleeping pill for midnight wakes

    • Last Update: 2011-11-24
    • Source: Internet
    • Author: User
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    Source: China Council for the promotion of drugs compiles 2011-11-24 transcept's third application for its sleeping pills, which ended on Wednesday with approval The FDA approved its drug, Intermezzo, a low-dose zolpidem tartrate, to help people wake up in the middle of the night Intermezzo is the first approved product by Point Richmond, a CA based developer, and the FDA said it was the first drug to be approved for marketing for the treatment of waking up at night The company vomited its bad breath after two unsuccessful attempts to get the drug approved The most recent was this summer, when U.S regulators voiced concerns about the safety risks of driving after patients take drugs To address safety concerns, developers have designed a dosage strategy that enables drug regulators to approve the drug The recommended dose of the company's approved drug is 1.75 mg for women and 3.5 mg for men The difference is due to the slower metabolism of zolpidem tartrate in women than in men It also recommends that patients not take the drug if they want to be awakened four hours ago FDA has carried out a strict safety risk assessment on new sleep drugs, and transcept has undoubtedly shown considerable tenacity in the process of new drug approval Today, an official body officially issued an optimistic statement about the safety benefits of the new treatment Intermezz is designed as sublingual buccal tablet, so that it can be absorbed rapidly in the oral cavity and quickly enter the body of patients to help them fall asleep quickly, which is also supported by the clinical research results Original link: http:// Sourceform = viral-tynt-fiercbiotech-fiercbiotech
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