Official Title: “Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers”

This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Subject), Crossover Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: placebo
  • single oral dose placebo
• Drug: zolpidem
  • single oral dose, 5 mg zolpidem
• Drug: zolpidem
  • single oral dose, 10 mg zolpidem

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • groups of 3-4 subjects for overnight polysomnography assessments
• Experimental: Low dose Zolpidem
• Experimental: High dose zolpidem

Primary Measures

• onset to persistent sleep
  • Time Frame: minutes
    Safety Issue?: No

Secondary Measures

• awakenings after sleep onset
  • Time Frame: minutes
    Safety Issue?: No

Inclusion Criteria:

• Age 18-55
• BMI 18-30 kg/m2
• body weight > 50 kg

Exclusion Criteria:

• no history of sleep disorder
• no concurrent medications
• no alcohol use
• no medical issues
• no smoking

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00716521

Study ID Number: A9001390

ClinicalTrials.gov Identifier: NCT00716521

Health Authority: United States: Institutional Review Board

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Link to ClinicalStudyResults.org