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Zopiclone's residual effects on actual driving performance in a standardized test: a pooled analysis of age and sex effects in 4 placebo-controlled studies?

机译:标准化试验中佐匹克隆对实际驾驶性能的残留影响:4项安慰剂对照研究对年龄和性别影响的汇总分析?

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摘要

BACKGROUND: In many European countries, Canada, and Japan, the nonbenzodiazepine zopiclone is now among the most frequently prescribed hypnotic drugs. This finding can be explained by the growing view among physicians that zopiclone is more effective and safer than conventional benzodiazepines. However, in 4 studies using similar procedures, it has been shown that zopiclone 7.5 mg causes moderate to severe impairment in driving performance. OBJECTIVE: The goal of the present article was to review these studies and analyze the pooled data to determine whether the severity of effects is modified by the sex and age of the subjects. METHODS: The driving data of the placebo and zopiclone 7.5 mg evening treatment periods from a total of 4 studies conducted at Maastricht University were included in this pooled analysis. All studies were conducted according to balanced double-blind, crossover designs. The effects on driving were always measured the next morning, between 10 and 11 hours after administration, by using a standardized highway driving test. A total of 101 healthy volunteers of both sexes in equal proportions (with no reports of insomnia) participated. Subjects comprised young volunteers (age range, 21-45 years) in 3 studies and older volunteers (age range, 55-75 years) in the fourth study. RESULTS: Results show that zopiclone 7.5 mg has significant and clinically relevant performance-impairing effects on driving in the morning, until 11 hours after bedtime ingestion. The effects did not differ between male and female subjects and did not increase with age, at least until 75 years. The effects of zopiclone 7.5 mg are comparable to the effects of a mean blood alcohol concentration between 0.5 and 0.8 mg/mL, which has been associated with a 2- to 3-fold increase in the risk of becoming involved in a traffic accident. CONCLUSIONS: We concluded that patients using an evening dose of zopiclone 7.5 mg should avoid activity in skilled work and participation in traffic the morning after intake. General practitioners' beliefs regarding the beneficial safety profile of zopiclone may need adjustment, and patients using zopiclone 7.5 mg should be warned accordingly. There is no need to differentiate warnings about zopiclone's residual impairing effects depending on the sex of the patient.
机译:背景:在许多欧洲国家,加拿大和日本,非苯并二氮杂佐匹克隆现已成为处方最频繁的催眠药。这一发现可以通过医师之间日益增长的观点来解释,即佐匹克隆比传统的苯二氮卓类药物更有效,更安全。但是,在使用类似程序的4项研究中,已显示7.5 mg佐匹克隆可能导致中等至严重的驾驶性能损害。目的:本文的目的是回顾这些研究并分析汇总数据,以确定效应的严重性是否因受试者的性别和年龄而改变。方法:该汇总分析包括了在马斯特里赫特大学进行的总共4项研究中安慰剂和佐匹克隆7.5 mg晚间治疗期的驱动数据。所有研究均根据平衡的双盲,交叉设计进行。对驾驶的影响总是在第二天早晨服用后10到11个小时之间使用标准化的高速公路驾驶测试进行测量。共有101名男女平等比例的健康志愿者(无失眠报告)参加。受试者包括3项研究中的年轻志愿者(年龄范围21-45岁)和第四项研究中的老年志愿者(年龄范围55-75岁)。结果:结果显示,佐匹克隆7.5 mg对早晨开车至睡前摄取11个小时具有显着和临床相关的性能损害作用。男性和女性受试者的影响没有差异,并且至少在75岁之前不会随年龄增加。佐匹克隆7.5 mg的作用可与平均血液酒精浓度在0.5至0.8 mg / mL之间的作用相媲美,后者平均导致交通事故风险增加2至3倍。结论:我们得出的结论是,晚上服用佐匹克隆7.5毫克的患者应避免在摄入后的第二天早上从事熟练工作和参加交通活动。全科医生关于佐匹克隆的有益安全性的信念可能需要调整,使用佐匹克隆7.5 mg的患者应予以警告。无需根据患者的性别区分有关佐匹克隆的残留损害作用的警告。

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