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Last Updated: March 31, 2025

CLINICAL TRIALS PROFILE FOR ESZOPICLONE


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All Clinical Trials for eszopiclone

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00120250 ↗ Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder Completed Massachusetts General Hospital Phase 4 2005-06-01 The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.
NCT00167375 ↗ Testing the Nocturnal Sleep Latency Profile in Primary Insomnia Completed American Academy of Sleep Medicine 2005-01-01 This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.
NCT00167375 ↗ Testing the Nocturnal Sleep Latency Profile in Primary Insomnia Completed Sunovion 2005-01-01 This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for eszopiclone

Condition Name

27111000510152025InsomniaObstructive Sleep ApneaPrimary Insomnia[disabled in preview]
Condition Name for eszopiclone
Intervention Trials
Insomnia 27
Obstructive Sleep Apnea 11
Primary Insomnia 10
[disabled in preview] 0
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Condition MeSH

4313110051015202530354045Sleep Initiation and Maintenance DisordersSleep Apnea, ObstructiveSleep Apnea Syndromes[disabled in preview]
Condition MeSH for eszopiclone
Intervention Trials
Sleep Initiation and Maintenance Disorders 43
Sleep Apnea, Obstructive 13
Sleep Apnea Syndromes 11
[disabled in preview] 0
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Clinical Trial Locations for eszopiclone

Trials by Country

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Trials by Country for eszopiclone
Location Trials
United States 303
Japan 24
United Kingdom 6
India 3
Ukraine 2
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Trials by US State

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Trials by US State for eszopiclone
Location Trials
Massachusetts 21
California 18
Pennsylvania 13
Ohio 12
New Jersey 11
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Clinical Trial Progress for eszopiclone

Clinical Trial Phase

58.1%37.2%00510152025Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for eszopiclone
Clinical Trial Phase Trials
Phase 4 25
Phase 3 16
Phase 2/Phase 3 2
[disabled in preview] 0
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Clinical Trial Status

86.2%9.2%00102030405060CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for eszopiclone
Clinical Trial Phase Trials
Completed 56
Recruiting 6
Not yet recruiting 3
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Clinical Trial Sponsors for eszopiclone

Sponsor Name

trials05101520253035SunovionUniversity of California, San DiegoMassachusetts General Hospital[disabled in preview]
Sponsor Name for eszopiclone
Sponsor Trials
Sunovion 35
University of California, San Diego 5
Massachusetts General Hospital 5
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Sponsor Type

48.2%44.5%7.3%0-50510152025303540455055OtherIndustryNIH[disabled in preview]
Sponsor Type for eszopiclone
Sponsor Trials
Other 53
Industry 49
NIH 8
[disabled in preview] 0
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Eszopiclone: Clinical Trials, Market Analysis, and Projections

Introduction to Eszopiclone

Eszopiclone, marketed under the brand name Lunesta, is a nonbenzodiazepine hypnotic agent used for the treatment of insomnia. It is the S-enantiomer of zopiclone, another commonly used sleep aid. Here, we will delve into the clinical trials, market analysis, and future projections for eszopiclone.

Clinical Trials and Efficacy

Comparison with Zopiclone

A significant clinical trial comparing eszopiclone with zopiclone was conducted to assess their efficacy in treating insomnia. This Phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial involved 199 patients who were randomized to receive either zopiclone 7.5 mg or eszopiclone 3 mg orally for four weeks[1].

  • Primary Endpoint: The primary efficacy analysis was based on the Insomnia Severity Index (ISI) after four weeks of treatment. The results showed that eszopiclone was non-inferior to zopiclone, with no statistically significant difference in ISI values between the two groups at the end of the treatment period.
  • Secondary Endpoints: Polysomnography data revealed that eszopiclone increased total sleep time and improved sleep efficiency, similar to zopiclone.
  • Safety Profile: Both treatments had a similar safety profile, with common adverse events including dysgeusia, headache, dizziness, irritability, and nausea.

Long-Term Efficacy and Safety

Clinical trials supporting the efficacy of eszopiclone have also included longer-term studies. For instance, premarketing development programs for Lunesta involved clinical effectiveness studies that lasted up to six months. These studies included approximately 1550 patients and demonstrated the efficacy of eszopiclone in reducing sleep latency and improving sleep quality[4].

Market Analysis

Global Market Size and Growth

The global eszopiclone market has been growing steadily. As of 2024, the market size was estimated to be $2,022.10 million, and it is forecasted to reach $2,607.15 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.29% from 2024 to 2031[2].

Regional Market Breakdown

  • Europe: The European market for eszopiclone was valued at $319.55 million in 2024 and is expected to grow to $417.11 million by 2030, with a CAGR of 4.52%. The increasing recognition of the importance of good mental health and sleep, along with rising stress levels, has driven this growth[2].
  • Asia Pacific: This region held a share of 10.28% of the global market in 2024 and is anticipated to grow at a CAGR of 5.71% from 2023 to 2030. The growing need for effective pharmacological treatments for sleep disorders, coupled with increasing stress levels and lifestyle changes, has fueled this growth[2].
  • Latin America: The Latin American market was valued at $57.94 million in 2024 and is expected to reach $72.77 million by 2030. The increasing awareness of the importance of good sleep hygiene and the adverse effects of sleep disturbances on health have contributed to this growth[2].
  • Middle East and Africa: This region is growing at a CAGR of 3.58% during the forecast period, driven by improvements in healthcare infrastructure and increased access to medical services for sleep-related problems[2].

Market Drivers and Trends

Increasing Prevalence of Insomnia

Insomnia is a common sleep disorder affecting a significant portion of the global population. For instance, more than 10% of people in Europe suffer from insomnia regularly, and this prevalence is rising worldwide[2].

Growing Awareness of Mental Health

The increasing recognition of the importance of good mental health and sleep hygiene has led to a higher demand for effective treatments for sleep disorders. This trend is particularly evident in regions like Europe and the Asia Pacific, where stress levels and lifestyle changes are contributing to sleep problems[2].

Pharmaceutical Market Expansion

Pharmaceutical companies are expanding their presence in various regions, particularly in Latin America and the Middle East and Africa. This expansion, along with customized marketing and distribution strategies, has contributed to the growth of the eszopiclone market[2].

Competitive Landscape

The global eszopiclone market is competitive, with several key players focusing on strengthening their product portfolios and expanding their business. Companies such as Sunovion and Dr. Reddy's Laboratories are prominent in this market. These companies are investing in research and development to enhance their market position and cater to the growing demand for sleep disorder treatments[5].

Future Projections

Market Growth

The eszopiclone market is expected to continue growing, driven by the increasing prevalence of insomnia, growing awareness of mental health, and expanding pharmaceutical market presence. The forecasted CAGR of 5.29% from 2024 to 2031 indicates a robust growth trajectory for the market[2].

Regional Opportunities

Regions like the Asia Pacific and Latin America offer significant growth opportunities due to their large and growing populations, increasing urbanization, and rising awareness of sleep health. Pharmaceutical companies are likely to focus on these regions to expand their market share[2].

Technological and Regulatory Trends

Advancements in healthcare technology and changes in regulatory environments are expected to influence the market. For example, the European Medicines Agency's (EMA) assessment of eszopiclone has highlighted its efficacy and safety profile, which can impact future regulatory approvals and market access[3].

Key Takeaways

  • Efficacy and Safety: Eszopiclone has demonstrated efficacy comparable to zopiclone in treating insomnia, with improvements in total sleep time and sleep efficiency.
  • Market Growth: The global eszopiclone market is projected to grow at a CAGR of 5.29% from 2024 to 2031, driven by increasing demand for sleep disorder treatments.
  • Regional Trends: Europe, Asia Pacific, Latin America, and the Middle East and Africa are key regions driving market growth due to factors such as increasing awareness of mental health and expanding pharmaceutical market presence.
  • Competitive Landscape: Key players like Sunovion and Dr. Reddy's Laboratories are focusing on research and development to strengthen their market positions.

FAQs

What is eszopiclone used for?

Eszopiclone is used for the treatment of insomnia, helping to improve sleep quality by reducing sleep latency and increasing total sleep time.

How does eszopiclone compare to zopiclone in clinical trials?

Eszopiclone has been shown to be non-inferior to zopiclone in clinical trials, with similar efficacy in improving sleep parameters such as total sleep time and sleep efficiency.

What is the projected growth rate of the global eszopiclone market?

The global eszopiclone market is forecasted to grow at a Compound Annual Growth Rate (CAGR) of 5.29% from 2024 to 2031.

Which regions are driving the growth of the eszopiclone market?

The Asia Pacific, Europe, Latin America, and the Middle East and Africa are key regions driving the growth of the eszopiclone market due to increasing demand for sleep disorder treatments.

Who are the major players in the eszopiclone market?

Major players in the eszopiclone market include Sunovion and Dr. Reddy's Laboratories, among others, who are focusing on research and development to strengthen their market positions.

Sources

  1. Eszopiclone versus zopiclone in the treatment of insomnia | Clinics
  2. Eszopiclone market will grow at a cagr of 5.29% from 2024 to 2031 | Cognitive Market Research
  3. Lunivia, INN-eszopiclone - European Medicines Agency
  4. LUNESTA® (eszopiclone) tablets - FDA
  5. Eszopiclone Drug Market Report 2024 (Global Edition) | Cognitive Market Research

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