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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR ZOLPIDEM TARTRATE


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All Clinical Trials for Zolpidem Tartrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00044629 ↗ Combined Behavioral/Pharmacological Therapy for Insomnia Completed National Institute of Mental Health (NIMH) Phase 2 2001-09-01 This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
NCT00044629 ↗ Combined Behavioral/Pharmacological Therapy for Insomnia Completed Duke University Phase 2 2001-09-01 This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
NCT00084669 ↗ Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer Completed Massachusetts General Hospital N/A 2004-05-01 RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer. PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.
NCT00283790 ↗ Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo Completed Sanofi Phase 4 2006-01-01 Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zolpidem Tartrate

Condition Name

Condition Name for Zolpidem Tartrate
Intervention Trials
Insomnia 11
Healthy 6
Sleep Initiation and Maintenance Disorders 2
Heart Failure 1
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Condition MeSH

Condition MeSH for Zolpidem Tartrate
Intervention Trials
Sleep Initiation and Maintenance Disorders 15
Sleep Wake Disorders 2
Parasomnias 2
Dyssomnias 1
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Clinical Trial Locations for Zolpidem Tartrate

Trials by Country

Trials by Country for Zolpidem Tartrate
Location Trials
United States 50
Japan 8
United Kingdom 5
Canada 4
Italy 3
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Trials by US State

Trials by US State for Zolpidem Tartrate
Location Trials
Pennsylvania 4
North Carolina 4
Ohio 3
New York 3
Maryland 3
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Clinical Trial Progress for Zolpidem Tartrate

Clinical Trial Phase

Clinical Trial Phase for Zolpidem Tartrate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Zolpidem Tartrate
Clinical Trial Phase Trials
Completed 23
Recruiting 1
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Clinical Trial Sponsors for Zolpidem Tartrate

Sponsor Name

Sponsor Name for Zolpidem Tartrate
Sponsor Trials
Eisai Inc. 4
Sanofi 3
Transcept Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Zolpidem Tartrate
Sponsor Trials
Industry 21
Other 5
NIH 3
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Zolpidem Tartrate: Clinical Trials, Market Analysis, and Projections

Introduction

Zolpidem tartrate, a non-benzodiazepine hypnotic agent, is widely used for the short-term treatment of insomnia. This article delves into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in Sleep Onset and Maintenance

Clinical trials have consistently shown that zolpidem tartrate is effective in improving both sleep onset and sleep maintenance. A randomized clinical trial comparing zolpidem tartrate with placebo and lemborexant found that zolpidem significantly reduced latency to persistent sleep and improved sleep efficiency and wake-after-sleep onset (WASO)[1].

Dose-Response Studies

Studies examining different doses of zolpidem tartrate have provided insights into its efficacy and safety profile. For instance, a trial comparing 10mg and 15mg doses of zolpidem IR (immediate release) with placebo showed significant improvements in subjective sleep latency and sleep quality, although higher doses did not necessarily yield better outcomes and were associated with more adverse events[5].

Adverse Events and Safety

Clinical trials have highlighted the importance of monitoring adverse events associated with zolpidem tartrate. Common adverse events include next-morning sleepiness, dizziness, and headache. The incidence of adverse events increases with higher doses, emphasizing the need for careful dose titration[5].

Market Analysis

Current Market Size and Growth

The zolpidem tartrate market was valued at USD 1 billion in 2023 and is projected to reach USD 9.58 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.2% from 2024 to 2031. This growth is driven by several key factors[2].

Drivers of Market Growth

  • Increasing Prevalence of Insomnia: The rising incidence of insomnia and other sleep disorders globally is a significant driver of the market.
  • Advancements in Formulations: Improved patient compliance and efficacy due to extended-release and sublingual tablet formulations are boosting market growth.
  • Enhanced Diagnostic Tools and Mental Health Awareness: Better diagnostic tools and a greater understanding of mental health are leading to more prescriptions for zolpidem tartrate.
  • Expanding Healthcare Infrastructure: Global expansion of healthcare infrastructure and increasing healthcare spending are also contributing to market growth[2].

Market Segmentation

The zolpidem tartrate market is segmented based on application (tablets, sublingual tablets, oral sprays, extended-release tablets, film-coated tablets) and product (insomnia, sleep maintenance, sleep initiation, short-term treatment, chronic insomnia). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are also key segments[2].

Market Projections

Regional Analysis

The market is expected to grow significantly across various regions, with Asia-Pacific anticipated to be a major growth hub due to its large population and increasing healthcare spending. North America and Europe are also expected to contribute substantially to the market growth[4].

Competitive Landscape

The competitive landscape of the zolpidem tartrate market includes several key players and is characterized by intense competition. Market reports include analyses such as Porter’s Five Forces and PESTEL analysis to provide a comprehensive view of the market dynamics[2][4].

Technological and Formulation Trends

Advances in pharmaceutical science, particularly in the development of extended-release and sublingual formulations, are expected to continue driving the market. These formulations improve patient compliance and therapeutic outcomes, making them more attractive to both patients and healthcare providers[2].

Future Trends and Opportunities

Growing Awareness of Mental Health

The increasing awareness and importance given to mental health are expected to drive more prescriptions for zolpidem tartrate, as sleep disorders are often linked to mental health issues.

Aging Population

The global aging population is more prone to sleep-related problems, which will continue to drive the demand for zolpidem tartrate.

Emerging Markets

Emerging markets, particularly in Asia-Pacific and South America, offer significant growth opportunities due to their large populations and improving healthcare infrastructure[2][4].

Challenges and Restraints

Adverse Events and Safety Concerns

Despite its efficacy, zolpidem tartrate is associated with several adverse events, which can be a restraint to market growth. Managing these side effects and ensuring patient safety will be crucial.

Regulatory Scrutiny

Zolpidem tartrate, like other prescription sleep aids, is subject to regulatory scrutiny. Changes in regulations or safety guidelines can impact market dynamics.

Generic Competition

The availability of generic versions of zolpidem tartrate can reduce the market share of branded products, posing a challenge to manufacturers[2].

Key Takeaways

  • Zolpidem tartrate has been shown to be effective in clinical trials for improving sleep onset and maintenance.
  • The market for zolpidem tartrate is growing significantly, driven by the increasing prevalence of insomnia, advancements in formulations, and expanding healthcare infrastructure.
  • Regional growth, particularly in Asia-Pacific, is expected to be substantial.
  • Despite opportunities, the market faces challenges such as adverse events, regulatory scrutiny, and generic competition.

FAQs

What is the current market size of zolpidem tartrate?

The zolpidem tartrate market was valued at USD 1 billion in 2023[2].

What is the projected growth rate of the zolpidem tartrate market?

The market is expected to grow at a CAGR of 8.2% from 2024 to 2031[2].

What are the main drivers of the zolpidem tartrate market growth?

Key drivers include the increasing prevalence of insomnia, advancements in formulations, enhanced diagnostic tools and mental health awareness, and expanding healthcare infrastructure[2].

What are the common adverse events associated with zolpidem tartrate?

Common adverse events include next-morning sleepiness, dizziness, and headache[5].

How does the competitive landscape of the zolpidem tartrate market look?

The market is highly competitive, with several key players and intense competition. Market analyses such as Porter’s Five Forces and PESTEL analysis provide insights into the market dynamics[2][4].

Sources

  1. JAMA Network Open: "Comparison of Lemborexant With Placebo and Zolpidem Tartrate for Sleep Initiation and Maintenance in Adults With Insomnia: A Randomized Clinical Trial"[1].
  2. Market Research Intellect: "Zolpidem Tartrate Market Size, Share | Industry Research Report 2031"[2].
  3. ICRWorld: "World Zolpidem Tartrate Market Research Report 2025"[3].
  4. Cognitive Market Research: "Zolpidem Tartrate Market Report 2024 (Global Edition)"[4].
  5. VA Center for Medications Safety: "Appendix 1: Review of Various Trials using zolpidem at Higher Doses"[5].

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