Moldofsky H, Lue F A, Mously C, Roth-Schechter B, Reynolds W J
Centre for Sleep and Chronobiology, The Toronto Hospital, Western Division, Canada.
J Rheumatol. 1996 Mar;23(3):529-33.
This dose ranging, double blind, placebo controlled, modified crossover study examined whether zolpidem would improve the disturbed sleep, fatigue, mood and pain symptoms in patients with fibromyalgia (FM).
All symptoms were rated over 4 nights and 4 conditions for 16 consecutive nights during which 19 patients (mean age 42 years) randomly received placebo or zolpidem 5 mg, 10 mg, or 15 mg at bedtime.
The 16 patients who completed the study reported no significant differences in ratings of pain, number of tender points, mood, sleep quality, morning fatigue, morning sleepiness or ability to concentrate. Compared to the placebo group, patients treated with zolpidem recorded significantly reduced time to fall asleep, increased sleep time, reduced awakenings, overall improvement in sleep and daytime energy, but a lower rating for evening energy. Zolpidem at the 10 mg dose was rated most acceptable for sleep. Adverse incidence rates were highest in the placebo group and lowest in the zolpidem 10 mg group. One person withdrew because of migraine while taking zolpidem 10 mg.
Short term treatment with zolpidem (5 to 15 mg) does not affect the pain of FM, but is useful for sleep and daytime energy in this patient population.
本剂量范围、双盲、安慰剂对照、改良交叉研究旨在探讨唑吡坦是否能改善纤维肌痛（FM）患者的睡眠障碍、疲劳、情绪和疼痛症状。
在连续16个晚上的4个夜晚和4种情况下对所有症状进行评分，在此期间，19名患者（平均年龄42岁）在睡前随机接受安慰剂或5毫克、10毫克或15毫克的唑吡坦。
完成研究的16名患者报告，在疼痛评分、压痛点数量、情绪、睡眠质量、晨起疲劳、晨起嗜睡或注意力集中能力方面无显著差异。与安慰剂组相比，接受唑吡坦治疗的患者入睡时间显著缩短、睡眠时间增加、觉醒次数减少、睡眠和日间精力总体改善，但晚间精力评分较低。10毫克剂量的唑吡坦在睡眠方面的评分最可接受。不良事件发生率在安慰剂组最高，在唑吡坦10毫克组最低。一名患者在服用10毫克唑吡坦时因偏头痛退出研究。
短期使用唑吡坦（5至15毫克）不影响FM患者的疼痛，但对该患者群体的睡眠和日间精力有益。
