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唑吡坦的短期安全性特征:认知影响的客观测量。

Short-term safety profile of zolpidem: objective measures of cognitive effects.

机构信息

Centre for Sleep/Wake Disorders, Kempenhaeghe, Sterkselseweg 65, 5591 Ve Heeze, The Netherlands.

出版信息

Eur Psychiatry. 1997;12 Suppl 1:15-20. doi: 10.1016/s0924-9338(97)80016-8.

Abstract

The potential effects of zolpidem, a non-benzodiazepine hypnotic, on cognitive and psychomotor functions have been explored in more than 30 placebo controlled studies, and in many cases in comparison with benzodiazepine reference hypnotics (ie flunitrazepam, nitrazepam, triazolam). Daytime impact of drug administration on alertness has been studied with the Multiple Sleep Latency Test, and no significant clinical impairment has been found after zolpidem 5 to 10 mg, unlike benzodiazepines. Evaluation of the effects of zolpidem on attention and psychomotor skills (critical flicker fusion threshold, substitution or copying tests, choice reaction times or driving tests, etc) indicate that zolpidem at recommended doses (5 mg in elderly and 10 mg in adults) is unlikely to produce significant detrimental residual effects on daytime vigilance, concentration and coordination performances on the morning after intake. In accordance with its pharmacokinetic and pharmacodynamic properties, the effects on zolpidem on memory functions were limited to the first hours after administration and no significant difference was observed between zolpidem (5-10 mg) and placebo 6 hours after administration; longer memory impairment was observed with flunitrazepam or triazolam. Various groups of subjects were included in these studies, both young adults and elderly subjects, healthy volunteers and insomniac patients, and duration of treatment varied between one single dose and 28 days of repeated intake. In conclusion, experimental evidence demonstrates a satisfactory safety profile of zolpidem (5-10 mg) on daytime cognitive functions as compared to other hypnotics.

摘要

唑吡坦是一种非苯二氮䓬类催眠药,已有 30 多项安慰剂对照研究探讨了其对认知和精神运动功能的潜在影响,在许多情况下还与苯二氮䓬类参考催眠药(如氟硝西泮、硝西泮、三唑仑)进行了比较。药物对警觉性的日间影响已通过多次睡眠潜伏期试验进行了研究,结果发现,与苯二氮䓬类药物不同,唑吡坦 5-10mg 不会导致明显的临床损害。评估唑吡坦对注意力和精神运动技能(临界闪烁融合阈值、替代或复制测试、选择反应时间或驾驶测试等)的影响表明,在推荐剂量下(老年人 5mg,成年人 10mg),唑吡坦不太可能对白天警觉性、注意力和协调能力产生明显的有害残留影响摄入后次日上午。根据其药代动力学和药效学特性,唑吡坦对记忆功能的影响仅限于给药后最初几个小时,给药后 6 小时唑吡坦(5-10mg)与安慰剂之间无显著差异;氟硝西泮或三唑仑观察到较长时间的记忆损伤。这些研究包括了不同的受试者群体,包括年轻成年人和老年人、健康志愿者和失眠症患者,治疗时间从单次剂量到 28 天重复摄入不等。总之,实验证据表明,与其他催眠药相比,唑吡坦(5-10mg)在白天认知功能方面具有令人满意的安全性。

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