Sateia M J, Hauri P, Kripke D, Roehrs T
Sleep Disorders Center, Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire 03756.
J Clin Psychopharmacol. 1990 Aug;10(4 Suppl):28S-31S.
Data from evening questionnaires, reports of side effects, laboratory findings, and all-night respiratory measurements were collected on the 99 chronic insomniacs examined in this multicenter study. These data were used to compare the clinical safety and desirability of a benzodiazepine hypnotic with a very short half-life, midazolam 15 mg, with a hypnotic with a longer half-life, flurazepam 15 and 30 mg; both compounds were compared with a placebo control. There were 2 prestudy placebo nights followed by 14 consecutive nights of treatment. Of the 107 patients accepted, 99 completed the study. No marked adverse reactions were found in any area for any group. There was no increase in sleep apneas during the treatment period for any group. Results of this study provide additional evidence of the safety of benzodiazepine hypnotics.
在这项多中心研究中，对99名慢性失眠症患者进行了检查，并收集了他们晚上问卷的数据、副作用报告、实验室检查结果以及整夜呼吸测量数据。这些数据用于比较半衰期非常短的苯二氮䓬类催眠药咪达唑仑15毫克与半衰期较长的催眠药氟西泮15毫克和30毫克的临床安全性和适用性；两种化合物均与安慰剂对照进行比较。研究前有2个安慰剂夜晚，随后是连续14个夜晚的治疗。在接受治疗的107名患者中，99名完成了研究。任何组在任何方面均未发现明显不良反应。治疗期间任何组的睡眠呼吸暂停均未增加。本研究结果为苯二氮䓬类催眠药的安全性提供了更多证据。
