Treatment of Insomnia and Glucose Metabolism

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Insulin Resistance; Insomnia; Sleep

Treatments: Drug: Eszopiclone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00724282

15632

ESRC-124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

20 participants in 1 patient group

Eszopiclone or Placebo

Other group

Description:

Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.

Treatment:

Drug: Placebo

Drug: Eszopiclone