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Strengthened drowsiness warnings proposed for Zolpidem medicines

机译:建议加强唑吡坦药物的嗜睡警告

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摘要

STRENGTHENED warnings about the risk of next-day drowsiness after taking Zolpidem are to be included in revised product information, following a safety review by the European Medicines Agency. The review of Zolpidem, used for the short-term treatment of insomnia, was launched in light of reports of impaired driving or road accidents involving people who had taken the drug the night before. The EMA's Pharmacovigilance Risk Assessment Committee has advised that the existing 10mg daily dose detailed in the current product information must not be exceeded. Patients should take the lowest possible dose just before going to bed and should not take additional doses on the same night, according to PRAC recommendations following the review.
机译:在经过欧洲药品管理局的安全审查后,在服用修订版产品信息中应包含加强的有关服用唑吡坦后第二天嗜睡的警告。唑吡坦用于失眠的短期治疗,是根据前一天晚上服用该药的人驾驶或道路交通事故的报道而进行的。 EMA的药物警戒风险评估委员会建议,不得超过当前产品信息中详述的现有10mg日剂量。根据复查后的PRAC建议,患者应在就寝前服用尽可能低的剂量,并且不应在同一晚服用其他剂量。

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