Jiménez-Genchi Alejandro
Servicios Clínicos, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Secretaría de Salud, Distrito Federal, México.
Rev Med Inst Mex Seguro Soc. 2012 Sep-Oct;50(5):529-36.
to assess the efficacy and safety of zolpidem modified release (MR) on an "as per needed basis" in patients with chronic insomnia.
one hundred and thirty five adult patients with chronic insomnia were recruited. Participants received zolpidem MR 12.5 mg during a 12 weeks period. Severity and improvement of insomnia were assessed at baseline and at the end of study using the clinical global impression scale; sleep quality was assessed by the application of the Pittsburgh Sleep Quality Index; drug consumption behavior was evaluated through tablet counting; in addition its security was assessed by the registry of the adverse effects.
one hundred and fifteen patients completed the study; 83.7 % were considered improved or very improved, so that 66 % reached a normal or borderline condition. Twenty percent of subjects experienced adverse reactions; the most frequent were headache, excessive sleepiness, nausea and dizziness.
these data support the efficacy, safety and acceptance of zolpidem MR administered on an "as per needed" regimen for the treatment of chronic insomnia.
评估按需服用唑吡坦缓释剂(MR)治疗慢性失眠患者的疗效和安全性。
招募了135名成年慢性失眠患者。参与者在12周内服用12.5毫克唑吡坦MR。使用临床总体印象量表在基线和研究结束时评估失眠的严重程度和改善情况;通过匹兹堡睡眠质量指数评估睡眠质量;通过药片计数评估药物消费行为;此外,通过不良反应登记评估其安全性。
115名患者完成了研究;83.7%的患者被认为有所改善或显著改善,因此66%的患者达到正常或临界状态。20%的受试者出现不良反应;最常见的是头痛、嗜睡、恶心和头晕。
这些数据支持按需服用唑吡坦MR治疗慢性失眠的疗效、安全性和可接受性。