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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zaleplon AP formulation | Experimental | Gastric Retentive Dual Release Zaleplon (Zaleplon AP) |
|
| Placebo | Placebo Comparator | Identical placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zaleplon AP formulation | Drug | Gastric retentive dual release Zaleplon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Polysomnography tests for 2 consecutive nights at each treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Polysomnography tests for 2 consecutive nights at each treatment arm |
| To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Sleep Medicine | San Diego | California | United States | |||
| Miami Research Associates |
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| Placebo capsule |
| Drug |
Identical placebo capsule |
|
The change from baseline on the mean of drug nights 1 and 2 relative to placebo. |
| 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. | 2 consecutive mornings at each treatment arm |
| Miami |
| Florida |
| United States |
| Broward Research Group | Pembroke Pines | Florida | United States |
| CRG of St. Petersburg | St. Petersburg | Florida | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | United States |
| Rambam sleep center | Haifa | Israel |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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