Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Phase 4
Completed
- Conditions
- Insomnia
- Registration Number
- NCT00283790
- Lead Sponsor
- Sanofi
- Brief Summary
Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator
- Detailed Description
This is a crossover study, with 4 different treatments (Ambien, Lunesta, placebo, and flurazepam). The flurazepam arm always comes last due to the long washout period associated with it. The other 3 arms are randomized.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Psychometric testing: Critical Flicker Fusion (CFF) Choice Reaction Time (CRT) Immediate and Delayed Recall of Supraspan Word Lists (WRI and WRD) Compensatory Tracking Task (CTT) Digit Symbol Substitution Test (DSST)
- Secondary Outcome Measures
Name Time Method Efficacy Measures: Sleep measures from Morning Sleep Questionnaire Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo Leeds Sleep Evaluation Questionnaire (LSEQ) Bond & Lader (B&L) Visual Analog Scale Health Outcome Measures Sleep Treatment Questionnaire
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇸Bridgewater, New Jersey, United States
Sanofi-Aventis🇺🇸Bridgewater, New Jersey, United States