Phase 4
Completed N=31
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Poor Quality Sleep
Source: ClinicalTrials.gov NCT00460993 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Sleep Efficiency — 70.0; 65.8 percentage of sleep
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency |
70.0; 65.8 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00460993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.