頁籤選單縮合
題 名 | A Double-blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Zaleplon versus Zolpidem in Shortening Sleep Latency in Primary Insomnia=以雙盲隨機臨床試驗評估Zaleplon及Zolpidem在原發性嗜睡病人之減少睡眠延遲的效用及安全性 |
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作 者 | 黃玉書; 許世杰; 劉珣瑛; 陳志根; | 書刊名 | 長庚醫誌 |
卷 期 | 34:1 2011.01-02[民100.01-02] |
頁 次 | 頁50-56 |
分類號 | 415.939 |
關鍵詞 | 助眠劑; 非苯二氮平; 失眠; 睡眠潛伏期; Hypnotics; Non-benzodiazepine; Insomnia; Sleep latency; |
語 文 | 英文(English) |
中文摘要 | zaleplon zolpidem 48 45 10 mg zaleplon 10 mg zolpidem zaleplon zolpidem zolpidem zaleplon zolpidem zaleplon zolpidem |
英文摘要 | Background: Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia. Methods: This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 patients were enrolled, of which 45 patients completed the study. Patients who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each patient kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and quality of sleep, the number of awakenings and incidence of rebound insomnia. Results: The data revealed a significant decrease in sleep latency from baseline to Week 2 for patients receiving zaleplon 10 mg and zolpidem 10 mg. Patients receiving zaleplon exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received zolpidem. There was no significant difference in the frequency of adverse effects between the zaleplon and zolpidem groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the zaleplon group. Conclusion: There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects. |
本系統中英文摘要資訊取自各篇刊載內容。