Owen R T
Drugs Today (Barc). 2011 Apr;47(4):263-75. doi: 10.1358/dot.2011.47.4.1590792.
Eszopiclone is the single (S)-enantiomer of the cyclopyrrolone hypnotic zopiclone. It was marketed in the U.S. in December 2004. Its kinetics and possible mode of action, pivotal regulatory trials and its use in insomnia comorbid with other conditions are reviewed, together with trials in patients with obstructive sleep apnea syndromes. Safety and tolerability aspects are discussed, including its dysgeusic profile and effects on memory, cognitive and psychomotor function. U.S.-based pharmacoeconomic data are included together with the design features of key regulatory studies submitted for regulatory approval in Japan.
艾司佐匹克隆是环吡咯酮类催眠药佐匹克隆的单一(S)-对映体。它于2004年12月在美国上市。本文回顾了其动力学和可能的作用方式、关键的监管试验以及它在与其他疾病共病的失眠症中的应用,同时还包括阻塞性睡眠呼吸暂停综合征患者的试验。讨论了安全性和耐受性方面,包括其味觉障碍情况以及对记忆、认知和精神运动功能的影响。纳入了美国的药物经济学数据以及提交给日本监管机构批准的关键监管研究的设计特点。