一项为期 12 周、随机、双盲、安慰剂对照研究，评估 2 毫克艾司佐匹克隆对原发性和共病失眠的老年人睡眠/觉醒功能的影响。
A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.
机构信息
Department of Psychiatry, University of California San Diego, San Diego, CA 92093-0733, USA.
出版信息
Sleep. 2010 Feb;33(2):225-34. doi: 10.1093/sleep/33.2.225.
BACKGROUND
Longer-term pharmacologic studies for insomnia in older individuals are sparse.
OBJECTIVE
To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia.
METHODS
Participants (65-85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) < or = 6 h, and wake time after sleep onset (WASO) > or = 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, wellbeing, ability to function) were assessed. AEs were monitored.
RESULTS
Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values < or = 0.01), indicating no rebound. The most common AEs (> or = 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%).
CONCLUSION
In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and were maintained for 3 months, with no evidence of rebound insomnia following discontinuation. The 12 weeks of treatment were well tolerated.
CLINICAL TRIAL INFORMATION
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia; Registration #NCT00386334; URL - http://www.clinicaltrials.gov/ct2/show/NCT00386334?term=eszopiclone&rank=24
背景
老年人失眠的长期药物研究较为少见。
目的
评估 12 周的佐匹克隆治疗老年门诊失眠患者的疗效和安全性。
方法
参与者（65-85 岁）符合 DSM-IV-TR 失眠标准，总睡眠时间（TST）≤6 小时，入睡后觉醒时间（WASO）≥45 分钟。参与者被随机分为佐匹克隆 2 毫克（n=194）或安慰剂（n=194）12 周，随后进行 2 周的单盲安慰剂洗脱期。通过主观报告的睡眠（sTST、睡眠潜伏期 [sSL]、sWASO）和白天功能（警觉性、注意力、幸福感、功能能力）评估睡眠情况。监测不良事件（AE）。
结果
与安慰剂组相比，接受佐匹克隆 2 毫克治疗的患者在夜间平均睡眠时间和每个单独的时间点都有所延长，12 周双盲期间的 TST 测量值（P＜0.0001）。佐匹克隆治疗组双盲期间的平均 sTST 为 360.08 分钟，而基线时为 297.86 分钟，平均变化为 63.24 分钟。在双盲期间，与安慰剂相比，佐匹克隆治疗组的 sSL 也有显著改善，平均下降 24.62 分钟，而安慰剂组平均下降 19.92 分钟（P=0.0014）。佐匹克隆组的 WASO 也有显著下降（平均下降 36.4 分钟），而安慰剂组平均下降 14.8 分钟（P＜0.0001）。停药后，与基线相比，佐匹克隆组的睡眠参数均有统计学改善（P 值均≤0.01），表明无反弹。最常见的不良反应（AE）（发生率≥5%）为头痛（佐匹克隆 13.9%，安慰剂 12.4%）、味觉不佳（12.4%，1.5%）和鼻咽炎（5.7%，6.2%）。
结论
在这项针对老年人原发性慢性失眠症的佐匹克隆长期安全性和疗效的 IV 期试验中，与安慰剂相比，佐匹克隆显著改善了患者报告的睡眠和白天功能。改善发生在第一周内，并持续了 3 个月，停药后无失眠反弹迹象。12 周的治疗耐受性良好。
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