Ganzoni E, Gugger M
Medizinisches Departement, Synthélabo Pharma, Lausanne.
Praxis (Bern 1994). 1999 Jun 24;88(25-26):1120-7.
Evaluation and treatment of insomnia are frequent procedures in the physician's everyday practice, since many patients seek medical treatment for this condition. Knowledge of pharmacological therapeutical alternatives is therefore decisive, in order to identify the most efficaceous and safe therapy for the patient among the available hypnotics. The short-acting hypnotic zolpidem has been investigated in Switzerland in two multicenter safety studies in ambulatory practice. In the first study 8.9% (n = 125 of 1,972 treated patients), and in the second 7.2% of the patients (n = 175 of 1,833 treated patients) reported an adverse event. The most frequent events were related to the central nervous system (CNS) (somnolence, headache, confusion, vertigo); gastrointestinal and cutaneous symptoms were the most frequent non CNS-dependent effects. New, unknown or serious adverse events were not found and no specific risk factor or population at risk was identified. The safety profile of zolpidem is consistent with its known pharmacological properties, the results of previous clinical trials and the international experience obtained in large patients groups.
失眠的评估与治疗是医生日常诊疗中常见的操作，因为许多患者因这种情况寻求医疗帮助。因此，了解药物治疗的替代方法对于在现有的催眠药物中为患者确定最有效且安全的治疗方法至关重要。短效催眠药唑吡坦已在瑞士的两项门诊多中心安全性研究中进行了调查。在第一项研究中，8.9%（1972例接受治疗的患者中有125例），在第二项研究中7.2%的患者（1833例接受治疗的患者中有175例）报告了不良事件。最常见的事件与中枢神经系统（CNS）有关（嗜睡、头痛、意识模糊、眩晕）；胃肠道和皮肤症状是最常见的非中枢神经系统依赖性效应。未发现新的、未知的或严重的不良事件，也未确定特定的风险因素或高危人群。唑吡坦的安全性概况与其已知的药理特性、先前临床试验的结果以及在大量患者群体中获得的国际经验一致。
