This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Gastric retentive dual release Zaleplon
Identical placebo capsule
Pacific Sleep Medicine
San Diego, California, United States
Miami Research Associates
Miami, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
CRG of St. Petersburg
St. Petersburg, Florida, United States
To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time frame: 2 consecutive mornings at each treatment arm
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Vince and Associates Clinical Research
Overland Park, Kansas, United States
Rambam sleep center
Haifa, Israel