The efficacy and tolerability of the imidazopyridine hypnotic, zolpidem, were investigated in 119 elderly psychiatric in-patients complaining of insomnia in a double-blind, parallel-group, placebo-controlled trial. After a 7-day placebo washout period, patients were randomized to receive 10 or 20 mg/day zolpidem, or placebo for 21 days; thereafter, all patients received placebo for 7 days. Sleep was assessed by patient observation on days 0, 1, 7, 14, 21, 22 and 28. Compared with placebo, 20 mg/day zolpidem significantly improved total duration of sleep between day 0 and day 21, and this was maintained at day 28. After 10 or 20 mg/day zolpidem, there was also a trend towards improvement in all other sleep parameters, which remained above baseline at day 28. Zolpidem was well tolerated with no withdrawal symptoms during the second 7-day placebo treatment period. Daytime drowsiness was reported in three patients receiving 20 mg/day zolpidem and in one receiving 10 mg/day zolpidem, but there was no significant increase in daytime drowsiness between days 0 and 21. Ataxia occurred in two, one and one patient, respectively, treated with 20 mg/day zolpidem, 10 mg/day zolpidem and placebo. The incidences of other adverse events or effects on clinical and laboratory parameters were minimal and similar in all three treatment groups. It is concluded that, in elderly psychiatric patients, 10 mg/day zolpidem can be used to treat insomnia and can be safely added to concomitant psychotropic treatment without inducing daytime drowsiness.

译文

:在一项双盲,平行分组,安慰剂对照试验中,对119名抱怨失眠的老年精神病住院患者,研究了咪唑并吡啶催眠药唑吡坦的疗效和耐受性。经过7天的安慰剂冲洗期后,患者被随机分配接受10或20 mg /天的唑吡坦或安慰剂治疗21天。此后,所有患者接受安慰剂治疗7天。通过在第0、1、7、14、21、22和28天观察患者的睡眠来评估睡眠情况。与安慰剂相比,每天20 mg /日的唑吡坦显着改善第0天至第21天之间的总睡眠时间,并在第2天保持不变28.每天服用10或20 mg唑吡坦后,所有其他睡眠参数也有改善的趋势,在第28天仍高于基线。在第二个7天安慰剂治疗期间,唑吡坦耐受性良好,没有戒断症状。据报告三名接受20 mg / day唑吡坦的患者白天嗜睡,而另一名接受10 mg / day唑吡坦的患者白天嗜睡,但是在第0天和第21天之间,白天嗜睡没有明显增加,分别有2名,1名和1名患者发生了共济失调,用20毫克/天的唑吡坦,10毫克/天的唑吡坦和安慰剂治疗。在所有三个治疗组中,其他不良事件或对临床和实验室参数的影响的发生率极低,且相似。结论是,在老年精神病患者中,10 mg /天的唑吡坦可以用于治疗失眠,并且可以安全地添加到伴随的精神治疗中,而不会引起白天的嗜睡。

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