Trazodone for sleep disturbance after alcohol detoxification: A double-blind, placebo-controlled trial
Trazodone for sleep disturbance after alcohol detoxification: A double-blind, placebo-controlled trial
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DOI：
10.1111/j.1530-0277.2008.00742.x
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发表时间：
2008-09-01
影响因子：
3.2
通讯作者：
Stein, Michael D.
中科院分区：
文献类型：
--
作者：
Friedmann, Peter D.;Rose, Jennifer S.;Stein, Michael D.
背景资料：曲唑酮是酒精依赖患者睡眠障碍的常用处方，但其安全性和有效性尚不清楚。研究方法：我们进行了一项随机、双盲、安慰剂对照试验，在173名酒精戒断患者中进行了为期12周的低剂量曲唑酮（睡前50至150 mg）治疗，这些患者在经过验证的睡眠质量测量中报告了当前的睡眠障碍或在先前的戒酒期间。主要结果的比例禁欲和饮料每天饮酒超过6个月，睡眠质量也assessed.Results：瓮随机化平衡的基线功能之间的88例受试者接受曲唑酮和85例接受安慰剂。曲唑酮组在研究药物给药期间戒断天数比例的改善较少（基线和3个月之间的平均变化：-0.12; 95% CI：-0.15至-0.09），以及研究药物停药后每个饮酒日的饮酒次数增加（基线和6个月之间的平均变化为4.6; 95% CI：2.1 - 7.1）。曲唑酮在给药期间与睡眠质量改善相关（匹兹堡睡眠质量指数在基线和3个月之间的平均变化：-3.02; 95%CI：-3.38至-2.67），但在停止后睡眠质量与安慰剂持平。曲唑酮，尽管对睡眠质量有短期的好处，可能会阻碍戒毒后饮酒量的改善，并导致停止饮酒后饮酒量的增加。在进一步的研究确定其益处和安全性之前，不能有把握地推荐在酒精中毒脱毒后的一段时间内常规开始曲唑酮治疗睡眠障碍。
Background: Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown. Methods: We conducted a randomized, double-blind, placebo-control trial of low-dose trazodone (50 to 150 mg at bedtime) for 12 weeks among 173 alcohol detoxification patients who reported current sleep disturbance on a validated measure of sleep quality or during prior periods of abstinence. Primary outcomes were the proportion of days abstinent and drinks per drinking day over 6-months; sleep quality was also assessed.Results: Urn randomization balanced baseline features among the 88 subjects who received trazodone and 85 who received placebo. The trazodone group experienced less improvement in the proportion of days abstinent during administration of study medication (mean change between baseline and 3 months: -0.12; 95% CI: -0.15 to -0.09), and an increase in the number of drinks per drinking day on cessation of the study medication (mean change between baseline and 6 months, 4.6; 95% CI: 2.1 to 7.1). Trazodone was associated with improved sleep quality during its administration (mean change on the Pittsburgh Sleep Quality Index between baseline and 3 months: -3.02; 95% CI: -3.38 to -2.67), but after it was stopped sleep quality equalized with placebo.Conclusions: Trazodone, despite a short-term benefit on sleep quality, might impede improvements in alcohol consumption in the postdetoxification period and lead to increased drinking when stopped. Until further studies have established benefits and safety, routine initiation of trazodone for sleep disturbance cannot be recommended with confidence during the period after detoxification from alcoholism.