Treatment of Insomnia and Glucose Metabolism

This study has been completed.
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: July 25, 2008
Last updated: October 15, 2015
Last verified: October 2015
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

Condition Intervention Phase
Insulin Resistance
Drug: Eszopiclone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test [ Time Frame: at the end of each treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Eszopiclone or Placebo
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Drug: Eszopiclone
Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Other Name: Lunesta
Drug: Placebo
Placebo by mouth daily at bedtime for 9 days

Detailed Description:
Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age between 35 and 64
  • must have long-standing trouble falling or staying asleep
  • BMI between 22 and 34 kg/m2

Exclusion Criteria:

  • sleep apnea or other sleep disorder other than insomnia
  • diagnosis of diabetes requiring treatment with pills or insulin
  • smoking
  • night or shift work
  • presence of a medical condition that can disrupt sleep
  • women only: irregular menstrual periods or pregnancy
  • use of medications/compounds that can disrupt sleep
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00724282

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Plamen D Penev, MD, PhD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT00724282     History of Changes
Other Study ID Numbers: 15632  ESRC-124 
Study First Received: July 25, 2008
Results First Received: September 10, 2015
Last Updated: October 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
insulin secretion
insulin action
glucose tolerance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Central Nervous System Depressants
Hypnotics and Sedatives
Physiological Effects of Drugs processed this record on May 24, 2016