Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Sunovion
• Treatments: Eszopiclone

Criteria

Inclusion Criteria:

• Nursing Home Patients

• Age 65 and above

Exclusion Criteria:

• Under age 65

• Anticipated short stay (short term or hospice)

• Severe behavioral disturbance

• Unstable drug regimen in prior 2 weeks

• Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

• once per week in prior 2 weeks

• Use of a potent inhibitor of CYP3A4

• Parkinson's with uncontrolled tremor

• Severe Dementia

• Severe Sleep Apnea

• Inability to tolerate wrist Actigraphy

• Sleep Efficiency >75%

• Sleep apnea

• Sleep efficiency of greater than 75% during the night.