Hajak G, Bandelow B
Department of Psychiatry, Georg-August-University of Göttingen, Germany.
Int Clin Psychopharmacol. 1998 Jul;13(4):157-67. doi: 10.1097/00004850-199807000-00002.
The subjective response to treatment with zolpidem, an imidazopyridine hypnotic, was assessed in patients with insomnia under normal treatment conditions in an outpatients' practice in Germany. The uncontrolled clinical surveillance study included 16944 outpatients with subjective difficulties in initiating and/or maintaining sleep. Office-based neurologists, psychiatrists, internists and general practitioners were asked individually to adjust the dosage of zolpidem (age < or = 65 years, 10-20 mg; age > 65 years, 5-10 mg) over a recommended period of 3-4 weeks. In total, 82.8% of patients completed the survey (36% men, 64% women, mean age 58.8 +/- 14.9 years; 58.6% without previous hypnotic medication; duration of sleep complaints > 6 months in 40.6%, 1-6 months in 27.8%). Most patients (63.9%) took zolpidem on a daily basis. The average dose was 10 mg zolpidem per night in 74.8%, 5 mg in 19.8%, 20 mg in 2.4% and > 20 mg in 10 cases. Most physicians (87.6%) rated the efficacy of zolpidem as 'very good' or 'good'. One hundred and eighty-two (1.1%) of the 16 944 patients reported 268 adverse events (one adverse event in 113 cases, two adverse events in 53 cases and more than two adverse events in 16 cases). One hundred and eighteen (64.8%) of these patients (0.006% of all participating patients) discontinued treatment because of adverse events. Nausea (n = 36), dizziness (n = 35), malaise (n = 23), nightmares (n = 20), agitation (n = 19), and headache (n = 18) were the most common adverse events. There was one serious adverse reaction in a 48-year-old women who developed paranoid symptoms during the documentation phase. No life-threatening adverse event occurred. The adverse event profile reflected the pharmacological properties of zolpidem and underlined the cumulative good experience with the drug internationally.
在德国一家门诊诊所的正常治疗条件下，对患有失眠症的患者使用咪唑吡啶类催眠药唑吡坦治疗的主观反应进行了评估。这项非对照临床监测研究纳入了16944名在入睡和/或维持睡眠方面存在主观困难的门诊患者。要求门诊神经科医生、精神科医生、内科医生和全科医生在3 - 4周的推荐疗程内分别调整唑吡坦的剂量（年龄≤65岁，10 - 20毫克；年龄＞65岁，5 - 10毫克）。总共有82.8%的患者完成了调查（男性36%，女性64%，平均年龄58.8±14.9岁；58.6%的患者此前未使用过催眠药物；40.6%的患者睡眠问题持续时间＞6个月，27.8%的患者为1 - 6个月）。大多数患者（63.9%）每天服用唑吡坦。平均剂量为每晚10毫克唑吡坦的患者占74.8%，5毫克的占19.8%，20毫克的占2.4%，10例患者剂量＞20毫克。大多数医生（87.6%）将唑吡坦的疗效评为“非常好”或“好”。在16944名患者中，有182名（1.1%）报告了268起不良事件（113例患者报告1起不良事件，53例患者报告2起不良事件，16例患者报告2起以上不良事件）。其中118名患者（占所有参与患者的0.006%）因不良事件而停止治疗。恶心（n = 36）、头晕（n = 35）、不适（n = 23）、噩梦（n = 20）、激动（n = 19）和头痛（n = 18）是最常见的不良事件。一名48岁女性在记录阶段出现偏执症状，发生了1起严重不良反应。未发生危及生命的不良事件。不良事件情况反映了唑吡坦的药理特性，并突出了国际上对该药物积累的良好经验。
