The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,105
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
Pfizer Investigational Site
Mobile, Alabama, United States
Adverse Events
Time frame: Day 45
Pulse and Blood Pressure
Time frame: Day 45
Subjective proportion of nights having difficulty sleeping
Time frame: Day 45
Subjective Sleep Latency
Time frame: Day 45
Subjective Wake After Sleep Onset
Time frame: Day 45
Subjective Number of Awakenings
Time frame: Day 45
Subjective Total Sleep Time
Time frame: Day 45
Subjective Assessment of Sleep Quality
Time frame: Day 45
Subjective Assessment of Ease of Awakening
Time frame: Day 45
Subject Global Evaluation
Time frame: Day 45
Pittsburg Sleep Quality Index
Time frame: Day 45
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
New Port Richey, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
...and 13 more locations