CLINICAL TRIALS PROFILE FOR ZALEPLON

505(b)(2) Clinical Trials for Zaleplon

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00878553 ↗	Study of Sleep-maintenance Activity of 3 Doses of SKP-1041	Completed	INC Research Limited	Phase 2	2010-05-01	SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.
New Formulation	NCT00878553 ↗	Study of Sleep-maintenance Activity of 3 Doses of SKP-1041	Completed	Somnus Therapeutics, Inc.	Phase 2	2010-05-01	SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

All Clinical Trials for Zaleplon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00167479 ↗	A Study of Risperidone Monotherapy in Bipolar Anxiety	Completed	Janssen, LP	Phase 4	2003-09-01	The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
NCT00167479 ↗	A Study of Risperidone Monotherapy in Bipolar Anxiety	Completed	University of South Florida	Phase 4	2003-09-01	The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
NCT00277654 ↗	Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder	Completed	Janssen Pharmaceuticals	Phase 3	2004-02-01	The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).
NCT00277654 ↗	Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder	Completed	University of Cincinnati	Phase 3	2004-02-01	The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).
NCT00277654 ↗	Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder	Completed	Lindner Center of HOPE	Phase 3	2004-02-01	The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).
NCT00278772 ↗	Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania	Completed	Abbott	Phase 3	2003-08-01	The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.
NCT00278772 ↗	Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania	Completed	University of Cincinnati	Phase 3	2003-08-01	The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.

Clinical Trial Conditions for Zaleplon

Condition Name

Condition Name for Zaleplon
Intervention	Trials
Bipolar Disorder	4
Panic Disorder	3
Generalized Anxiety Disorder	3
Healthy	3

Condition MeSH

Condition MeSH for Zaleplon
Intervention	Trials
Disease	6
Bipolar Disorder	5
Anxiety Disorders	5
Sleep Initiation and Maintenance Disorders	5

Clinical Trial Locations for Zaleplon

Trials by Country

Trials by Country for Zaleplon
Location	Trials
United States	36
Lithuania	1
Spain	1
Taiwan	1
Germany	1

Trials by US State

Trials by US State for Zaleplon
Location	Trials
Texas	6
Ohio	6
Florida	5
California	4
Pennsylvania	2

Clinical Trial Progress for Zaleplon

Clinical Trial Phase

Clinical Trial Phase for Zaleplon
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Zaleplon
Clinical Trial Phase	Trials
Completed	18
Recruiting	1
Terminated	1

Clinical Trial Sponsors for Zaleplon

Sponsor Name

Sponsor Name for Zaleplon
Sponsor	Trials
University of South Florida	3
Lindner Center of HOPE	3
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Zaleplon
Sponsor	Trials
Other	18
Industry	14
U.S. Fed	2