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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ZALEPLON


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

Trials by Country for Zaleplon
Location Trials
United States 36
Sweden 1
Israel 1
Lebanon 1
Belgium 1
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Trials by US State

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

Clinical Trial Status for Zaleplon
Clinical Trial Phase Trials
Completed 18
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Zaleplon

Sponsor Name

Sponsor Name for Zaleplon
Sponsor Trials
University of South Florida 3
Lindner Center of HOPE 3
Roxane Laboratories 2
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Sponsor Type

Sponsor Type for Zaleplon
Sponsor Trials
Other 18
Industry 14
U.S. Fed 2
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Zaleplon: Clinical Trials, Market Analysis, and Projections

Introduction to Zaleplon

Zaleplon, sold under the brand name Sonata among others, is a sedative-hypnotic drug belonging to the nonbenzodiazepine hypnotic class. It is primarily used to treat insomnia by reducing the time it takes to fall asleep and improving sleep latency[5].

Clinical Trials and Efficacy

Recent Clinical Trials

One notable clinical trial involves the development of AZ-007 (Staccato® zaleplon) by Alexza Pharmaceuticals. This Phase 1 clinical trial aims to assess the safety, tolerability, and pharmacokinetic parameters of an inhaled form of zaleplon. The trial enrolls approximately 40 healthy volunteers and compares four doses of AZ-007 (ranging from 0.5 to 4.0 mg) to a placebo. This novel delivery method is expected to offer rapid pharmacokinetic properties, making it a promising candidate for treating insomnia[3].

Efficacy in Insomnia Treatment

A multicenter study compared the efficacy and safety of zaleplon with those of placebo and zolpidem in outpatients with insomnia. The study found that zaleplon significantly reduced sleep latency at doses of 10 and 20 mg compared to placebo during all four weeks of treatment. Additionally, zaleplon did not show evidence of rebound insomnia or withdrawal symptoms upon discontinuation, unlike zolpidem, which had a higher incidence of these issues[1].

Pharmacokinetics and Safety Profile

Rapid Onset and Clearance

Zaleplon is characterized by its rapid absorption and short half-life. It reaches peak concentration in approximately one hour and has a terminal-phase elimination half-life of about one hour. This rapid clearance means that zaleplon does not accumulate with once-daily administration and its pharmacokinetics are dose-proportional in the therapeutic range. Studies have shown that psychomotor impairment caused by zaleplon is no longer present as early as 2-4 hours post-dosing[4].

Safety and Side Effects

Clinical trials have generally shown that zaleplon has a favorable safety profile. It does not significantly increase daytime anxiety or cause memory impairment beyond a few hours post-dosing. However, like other sedative-hypnotics, zaleplon can cause complex sleep behaviors, and patients should be warned about these potential risks[4].

Market Analysis

Global Market Trends

The global zaleplon market is expected to grow significantly over the next few years. The market is driven by increasing prevalence of insomnia, rising stress levels, and growing awareness about treatment options for insomnia. The market size is projected to increase from its current value to a higher figure by 2029, with a compound annual growth rate (CAGR) that reflects the growing demand for insomnia treatments[2][5].

Market Segmentation

The zaleplon market is segmented by product type (5mg and 10mg) and dosage form (oral and intranasal). The oral form is the most common, but the intranasal form, such as the Staccato® zaleplon, is emerging as a promising alternative. Geographically, the market is divided into regions such as the Americas, APAC, Europe, and the Middle East & Africa, with the United States, China, and Europe being key markets[2][5].

Key Players

The global zaleplon market is dominated by several key players, including Aurobindo Pharma, Cipla, Mylan Pharmaceuticals, Novartis, Teva Pharmaceuticals, and Unichem Laboratories. These companies occupy a significant share of the market and are driving innovation and growth through various product developments and market strategies[2].

Market Projections

Growth Forecast

The global zaleplon market is expected to grow at a CAGR of a certain percentage from 2023 to 2029. The United States, China, and European markets are anticipated to see substantial growth, driven by increasing demand for effective insomnia treatments. The market size is projected to increase significantly by 2029, reflecting the expanding need for sedative-hypnotic medications[2][5].

Emerging Opportunities

The increasing prevalence of anxiety, seizures, and insomnia, along with rising concerns about stress prevention, are expected to offer significant opportunities for the zaleplon market. However, factors such as the demand for cost-effective over-the-counter (OTC) sleep aids and concerns about the safety and efficacy profiles of prescription drugs may pose challenges to market growth[5].

Challenges and Limitations

Safety and Efficacy Concerns

While zaleplon has a favorable safety profile compared to some other sedative-hypnotics, it is not without risks. Complex sleep behaviors and potential rebound insomnia upon discontinuation are concerns that need to be addressed. Additionally, the efficacy of zaleplon can vary among patients, and some may experience side effects that limit its use[1][4].

Competition from Alternative Treatments

The market for insomnia treatments is competitive, with various OTC and prescription options available. The rise in demand for cost-effective alternatives and natural sleep aids can potentially hamper the growth of the zaleplon market. However, the specific benefits of zaleplon, such as its rapid onset and short half-life, position it as a valuable treatment option for many patients[5].

Key Takeaways

  • Clinical Efficacy: Zaleplon is effective in reducing sleep latency and improving sleep quality without significant rebound insomnia or withdrawal symptoms.
  • Pharmacokinetics: Zaleplon has a rapid onset and short half-life, making it suitable for treating insomnia with minimal daytime impairment.
  • Market Growth: The global zaleplon market is expected to grow significantly, driven by increasing demand for insomnia treatments.
  • Market Segmentation: The market is segmented by product type and dosage form, with key players dominating the landscape.
  • Challenges: Safety concerns and competition from alternative treatments are potential challenges to market growth.

FAQs

What is zaleplon used for?

Zaleplon is used to treat insomnia by reducing the time it takes to fall asleep and improving sleep latency.

What are the common dosages of zaleplon?

The common dosages of zaleplon are 5mg and 10mg, administered orally or intranasally.

What are the key benefits of zaleplon?

Zaleplon has a rapid onset of action, short half-life, and does not accumulate with once-daily administration, reducing the risk of rebound insomnia and withdrawal symptoms.

Who are the key players in the zaleplon market?

Key players include Aurobindo Pharma, Cipla, Mylan Pharmaceuticals, Novartis, Teva Pharmaceuticals, and Unichem Laboratories.

What are the potential challenges to the zaleplon market?

Challenges include safety concerns, competition from alternative treatments, and the demand for cost-effective OTC sleep aids.

Sources

  1. Psychiatrist.com: "Sleep Latency Is Shortened During 4 Weeks of Treatment With Zaleplon"
  2. Research Reports World: "Global Zaleplon Market Growth 2023-2029"
  3. BioSpace: "Alexza Pharmaceuticals, Inc. Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial"
  4. Pfizer Labeling: "Warning: Complex Sleep Behaviors"
  5. The Insight Partners: "Zaleplon Market Dynamics 2021-2031"

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