Effects of Daytime Eszopiclone Administration in Shift Workers

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; Sunovion
• Treatments: Eszopiclone

Criteria

Inclusion Criteria:

• Age 20-50 (men or women)

• Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)

• A willingness and ability to comply with study procedures

• If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device [IUD]).

Exclusion Criteria:

• Current diagnosis of DSM-IV Axis I disorder (other than insomnia)

• Regular treatment (>1time/wk) with CNS-active medication within 1 month of first inpatient visit

• Uncontrolled medical illness that would interfere with participation in the study

• BMI>32 or < 19.8 kg/m2

• Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD

• Periodic Leg Movement of Sleep Index (PLMSi)>20/hr of sleep or Respiratory Desaturation Index (RDI)>15 on polysomnography (PSG)

• Current alcohol or drug dependence/abuse

• Menopausal or peri-menopausal symptoms that disrupt sleep

• Pregnant, lactating, or planning to become pregnant

• Current smoking of more than 10 cigarettes per day

• Current use of over the counter sleep aids such as Benadryl or melatonin