NCT03160404

Zolpidem or Exercise for Insomnia?

The Effects of Zolpidem Compared With Exercise on Chronic Insomnia

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universidade Federal de Goias · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy. Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia. Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and SF-36 questionnaires. Hypothesis: Considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Zolpidem	The ZOLPIDEM group will be treated with zolpidem 10mg/night
BEHAVIORAL	Exercise	The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Timeline

• Start date: 2018-04-16
• Primary completion: 2019-12-30
• Completion: 2020-02-15
• First posted: 2017-05-19
• Last updated: 2021-03-01

Locations

1 site across 1 country: Brazil