THE EFFECT OF ZOLPIDEM IN PATIENTS WITH FIBROMYALGIA - A DOSE-RANGING, DOUBLE-BLIND, PLACEBO-CONTROLLED, MODIFIED CROSSOVER STUDY

Objective, This dose ranging, double blind, placebo controlled, modifi ed crossover study examined whether zolpidem would improve the disturb ed sleep, fatigue, mood and pain symptoms in patients with fibromyalgi a (FM). Methods, All symptoms were rated over 4 nights and 4 condition s for 16 consecutive nights during which 19 patients (mean age 42 year s) randomly received placebo or zolpidem 5 mg, 10 mg, or 15 mg at bedt ime. Results, The 16 patients who completed the study reported no sign ificant differences in ratings of pain, number of tender points, mood, sleep quality, morning fatigue, morning sleepiness or ability to conc entrate. Compared to the placebo group, patients treated with zolpidem recorded significantly reduced time to fall asleep, increased sleep t ime, reduced awakenings, overall improvement in sleep and daytime ener gy, but a lower rating for evening energy. Zolpidem at the 10 mg dose was rated most acceptable for sleep. Adverse incidence rates were high est in the placebo group and lowest in the zolpidem 10 mg group. One p erson withdrew because of migraine while taking zolpidem 10 mg. Conclu sion. 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 pat ient population.