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).

Clinical Trial Conditions for ZALEPLON

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for ZALEPLON

Trials by Country

Trials by Country for ZALEPLON
Location	Trials
United States	36
Bulgaria	1
Korea, Republic of	1
South Africa	1
United Kingdom	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
PHASE4	1
Phase 4	6
Phase 3	6

Clinical Trial Status

Clinical Trial Status for ZALEPLON
Clinical Trial Phase	Trials
Completed	18
Not yet recruiting	1
Unknown status	1

Clinical Trial Sponsors for ZALEPLON

Sponsor Name

Sponsor Name for ZALEPLON
Sponsor	Trials
University of South Florida	3
Lindner Center of HOPE	3
University of Cincinnati	2

Sponsor Type

Sponsor Type for ZALEPLON
Sponsor	Trials
Other	19
Industry	14
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for ZALEPLON

Last updated: October 31, 2025

Introduction

Zaleplon, marketed under the brand name Sonata, is a non-benzodiazepine hypnotic agent developed and marketed primarily for the short-term treatment of insomnia. Owned by Pfizer, Zaleplon belongs to the class of drugs known as pyrazolopyrimidines, acting selectively on GABA_A receptors to induce sleep without significant anxiolytic or muscle-relaxant properties. As a sleep aid, Zaleplon has been positioned as an alternative to traditional benzodiazepines, emphasizing rapid onset and minimal residual effects. This report provides an update on existing clinical trials, evaluates recent market dynamics, and projects future trends for Zaleplon.

Clinical Trials Update

Historical and Current Clinical Data

Since its initial approval by the FDA in 1999, Zaleplon's clinical profile has been extensively studied through phase I to phase IV trials. The initial trials demonstrated rapid onset of sleep, with approximately 20-minute median sleep initiation time, and a short half-life (~1 hour). These qualities favor an insomniac population seeking minimal next-day residual effects.

Recent and Ongoing Clinical Trials

While Zaleplon's primary developmental and approval pathway concluded over a decade ago, recent trials are limited, primarily focusing on its off-label uses and combination therapies. Notably:

• Off-label applications: Investigations into Zaleplon’s efficacy for sleep disturbances associated with psychiatric conditions, such as depression and anxiety disorders, have been sporadically conducted. Though some small-scale studies suggest potential benefits, these are not yet conclusive or practice-changing.

• Combination Therapy Trials: Ongoing research explores Zaleplon’s combination with other hypnotics or adjunct agents to improve sleep quality or treat comorbid conditions. These are primarily early-phase studies assessing safety spectra.

• Pharmacokinetics and Safety in Special Populations: Certain recent trials have examined Zaleplon’s safety profile in elderly populations and those with hepatic impairment. Findings generally confirm its tolerability with dose adjustments, emphasizing its safety profile compared to benzodiazepines.

Regulatory and Patent Status

Pfizer’s patent for Zaleplon expired in 2014, leading to increased generic competition. Substitutes and generics have entered various markets, which influence sales and clinical research funding.

Conclusion: The absence of recent extensive phase III or IV pivotal trials indicates that Zaleplon is largely established in its clinical profile, with ongoing research focusing on supplementary applications.

Market Analysis

Market Overview

The global hypnotic drugs market was valued at approximately USD 4.8 billion in 2022 and is projected to reach USD 6.4 billion by 2030, driven by increasing insomnia prevalence, aging populations, and limited medication options. Zaleplon retains niche positioning within this market, primarily characterized by:

• Early Insomnia Treatment Segment: Its rapid onset makes it preferred for sleep initiation difficulties.
• Minimal Residual Effects Segment: Its short half-life appeals to patients seeking less daytime drowsiness.

Competitive Landscape

Zaleplon faces competition from several classes:

• Other Non-Benzodiazepine Hypnotics: Eszopiclone (Lunesta), Zolpidem (Ambien), and newer agents like Suvorexant (Belsomra).
• Benzodiazepines: Older hypnotics like Temazepam, despite safety concerns.
• Dual Orexin Receptor Antagonists: Such as Belsomra, which target different insomnia pathways.

The competition is fierce, and market share for Zaleplon has declined in favor of agents offering broader efficacy or fewer side effects.

Market Trends and Challenges

• Generic Competition: Since patent expiry, Pfizer’s Zaleplon faces price erosion with generics dominating retail shelves.
• Regulatory Preferences: Increasing regulatory scrutiny encourages safer drugs with improved safety profiles; Zaleplon’s safety record remains favorable but less innovative compared to newer agents.
• Patient Demographics: The aging population still seeks effective sleep aids, but concerns over drug dependence and next-day impairment have shifted prescribing patterns toward non-pharmacological interventions and newer agents.

Regional Markets

• United States: Historically the largest market, with high penetration but slowing growth due to market saturation and generic competition.
• Europe: Similar dynamics, with increasing use of cognitive-behavioral therapy (CBT) and safety concerns limiting hypnotic prescriptions.
• Emerging Markets: Growth potential exists due to rising insomnia prevalence, but regulatory barriers and affordability issues limit rapid expansion.

Recent Sales Data

Pfizer reported a significant decline in Zaleplon revenues post-2015, aligning with generic entries and market saturation. However, niche applications retain some residual demand, particularly within specific patient subsets.

Market Projection

Considering current market dynamics:

• Short to Medium Term (1–5 years): Zaleplon’s market share is expected to decline further due to competition and patent expiration. Nevertheless, its established safety profile and suitability for specific patient groups could sustain modest demand in niche markets, especially where rapid onset and minimal residual effects are prioritized.

• Long Term (>5 years): Opportunities are limited unless pharmaceutical companies innovate around Zaleplon’s class, potentially through formulation improvements, combo therapies, or repositioning. The rise of non-pharmacological interventions like CBT for insomnia, coupled with conservative prescribing, could further constrain Zaleplon’s market share.

• Potential Resurgence Factors: Development of new formulations (e.g., sustained-release options), approval for wider indications, or strategic marketing toward specific populations (elderly, shift workers) could temporarily buoy sales.

Regulatory and Patent Outlook

Given patent expiry and increased competition, Pfizer’s focus appears shifted to pipeline medications. No recent indications or label expansions for Zaleplon are evident, limiting potential regulatory-driven market growth.

Key Challenges and Opportunities

Challenges

• Continued price erosion due to generic competition.
• Regulatory emphasis on safety, especially in vulnerable populations.
• Preference shift towards non-pharmacological treatments.
• Market maturity and saturation.

Opportunities

• Niche positioning for specific patient needs.
• Exploration of off-label uses and combination therapies.
• Development of improved formulations.
• Regional expansion into emerging markets with unmet sleep health needs.

Key Takeaways

• Stable yet declining market position: Zaleplon remains relevant for patients requiring rapid sleep induction but faces declining sales amidst generic competition.
• Limited pipeline activity: No recent significant clinical development or label expansions; future growth relies on niche applications or formulations.
• Market shifts favor newer agents and non-pharmacological options: Emphasize the importance of innovation for any resurgence.
• Regulatory landscape favors safety and minimal residual effects, aligning with Zaleplon’s profile, but innovation remains vital.
• Strategic positioning in specific populations, such as elderly patients or individuals with short-term insomnia episodes, could sustain modest demand.

Conclusion

Zaleplon’s clinical development history, competitive landscape, and market dynamics suggest its role will shrink substantially unless strategic innovations or niche applications emerge. Market projections indicate further erosion in sales, emphasizing the necessity for pharmaceutical companies to explore formulation improvements or new indications to sustain its relevance.

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FAQs

1. What is the primary therapeutic use of Zaleplon?
   Zaleplon is primarily used for the short-term treatment of insomnia, specifically to aid sleep initiation.

2. Are there ongoing clinical trials for Zaleplon’s new indications?
   No significant phase III or IV trials for new indications are currently ongoing; most recent research involves safety in special populations or combination therapies.

3. Why has Zaleplon’s market share declined?
   Patent expiry, competition from generic versions, and the rise of newer pharmacological agents and non-drug therapies have contributed to its market share decline.

4. Can Zaleplon be used in elderly populations?
   Yes, with dose adjustments, Zaleplon has demonstrated safety in elderly populations, but caution is advised due to sensitivity to sedative drugs.

5. Is there potential for Zaleplon in emerging markets?
   Yes, demand for short-term sleep aids in emerging markets offers growth opportunities, although regulatory and affordability barriers remain.

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References

[1] Food and Drug Administration. (1999). FDA approves Sonata for short-term treatment of insomnia.
[2] Pfizer Inc. Annual Reports and Market Data. (2022–2023).
[3] Global Sleep Aids Market Report. (2022). MarketsandMarkets.
[4] ClinicalTrials.gov database. (2023).
[5] IQVIA Sales Data. (2022).