Sleep Satisfaction and Psychomotor Performance of Adults

Phase 4

Completed

• Conditions: Sleep Disorders
• Interventions: Drug: ZOLPIDEM

• Registration Number: NCT01097382
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration

Secondary Objective:

To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMBIEN CR	ZOLPIDEM	AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime

Primary Outcome Measures

Name	Time	Method
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)	at Baseline, at V2 (26 +/- 2 days)

Secondary Outcome Measures

Name	Time	Method
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)	at Baseline, at V2 (26 +/- 2 days)

Trial Locations

Locations (6)

Investigational Site Number 4; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 10; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number 1; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 6; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 2; 🇦🇷 Capital Federal, Argentina

Investigational Site Number 3; 🇦🇷 La Plata, Argentina