The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study

J Rheumatol. 1996 Mar;23(3):529-33.


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).

Methods: 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.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Fatigue / drug therapy
  • Fatigue / etiology
  • Female
  • Fibromyalgia / complications
  • Fibromyalgia / drug therapy*
  • Fibromyalgia / psychology
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Male
  • Middle Aged
  • Mood Disorders / drug therapy
  • Mood Disorders / etiology
  • Pain / drug therapy
  • Pain / etiology
  • Placebos
  • Pyridines / administration & dosage*
  • Sleep Wake Disorders / drug therapy
  • Sleep Wake Disorders / etiology
  • Zolpidem


  • Hypnotics and Sedatives
  • Placebos
  • Pyridines
  • Zolpidem