The effect of zolpidem in patients with fibromyalgia (FM): a dose ranging, double blind, placebo controlled, modified crossover study
March 15, 1996
OBJECTIVE: 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).
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.
RESULTS: 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.
CONCLUSION: 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.
MCM: found in 16 pts improved sleep and daytime energy but not
in pain while taking 5 -15 mg/d
Moldofsky H, Lue FA, Mously C, Roth-Schechter B, Reynolds WJ