Jonas J M, Coleman B S, Sheridan A Q, Kalinske R W
Upjohn Laboratories, Kalamazoo, Mich. 49001.
J Clin Psychiatry. 1992 Dec;53 Suppl:19-31; discussion 32-3.
The efficacy, safety, and performance of triazolam was compared with those of other shorter-acting hypnotics acting on the gamma-aminobutyric acid (GABA) receptor--zopiclone, zolpidem, midazolam, brotizolam, temazepam, lormetazepam, and loprazolam. In all, 5506 patients participated in 38 clinical and epidemiologic studies, of whom 2462 were treated with triazolam in parallel-design and crossover studies. To provide clinically relevant comparisons, only studies using comparator agents in doses equipotent to the triazolam doses were included. Two general findings emerged. First, "serious" central nervous system side effects, such as excitement and violence, were not demonstrated for any of the hypnotic agents, including triazolam. Other central nervous system side effects, such as depression and irritability, were reported with equal frequencies for all the hypnotics reviewed. Rebound insomnia, reported intermittently with most of these agents, was short-lived and not clinically significant. So-called early morning insomnia was noted only once and does not appear to be a valid clinical entity. Daytime anxiety was not observed in large numbers of triazolam-treated subjects studied, which is contrary to claims that the drug is anxiogenic. Second, a remarkable similarity was found among all of these shorter-acting agents in terms of efficacy, side effects, and performance-related effects. This was particularly of note for zopiclone and zolpidem. Although claims have been made suggesting differences, evaluation of the studies herein showed that these nonbenzodiazepine hypnotics were indistinguishable from triazolam and other benzodiazepine hypnotics in their clinical and pharmacologic activity. Thus, different chemical structures did not a priori predict different clinical profiles when drugs share a similar mechanism of action.
将三唑仑的疗效、安全性和性能与其他作用于γ-氨基丁酸（GABA）受体的短效催眠药——佐匹克隆、唑吡坦、咪达唑仑、溴替唑仑、替马西泮、氯氮卓和氯普唑仑进行了比较。共有5506名患者参与了38项临床和流行病学研究，其中2462名患者在平行设计和交叉研究中接受了三唑仑治疗。为了提供具有临床相关性的比较，仅纳入了使用与三唑仑剂量等效的对照药物的研究。出现了两个总体发现。首先，包括三唑仑在内的任何催眠药均未表现出“严重”的中枢神经系统副作用，如兴奋和暴力行为。所审查的所有催眠药报告的其他中枢神经系统副作用，如抑郁和易怒，出现频率相同。大多数这些药物间歇性报告的反跳性失眠持续时间短，且在临床上无显著意义。所谓的早醒性失眠仅被记录过一次，似乎并不是一个有效的临床实体。在大量接受三唑仑治疗的受试者中未观察到日间焦虑，这与该药物具有致焦虑作用的说法相反。其次，在所有这些短效药物的疗效、副作用和性能相关效应方面发现了显著的相似性。这在佐匹克隆和唑吡坦方面尤为值得注意。尽管有人提出存在差异，但对本文研究的评估表明，这些非苯二氮䓬类催眠药在临床和药理活性方面与三唑仑和其他苯二氮䓬类催眠药没有区别。因此，当药物具有相似的作用机制时，不同的化学结构并不能预先预测不同的临床特征。
