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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR ROZEREM


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505(b)(2) Clinical Trials for Rozerem

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
OTC NCT02840591 ↗ Ramelteon and Citicoline for Delirium Withdrawn University of Texas Southwestern Medical Center Phase 4 2016-07-01 Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Rozerem

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00237497 ↗ Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia Completed Takeda Phase 3 2005-07-01 The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
NCT00247390 ↗ Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia. Completed Takeda Phase 3 2005-07-01 The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
NCT00316992 ↗ Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease Completed Takeda Phase 4 2006-04-01 The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
NCT00325728 ↗ Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease Completed Takeda Phase 2 2006-03-21 The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
NCT00337272 ↗ Treating Chronic Insomnia in Breast Cancer Patients Terminated Takeda Pharmaceuticals North America, Inc. Phase 4 2006-08-01 This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
NCT00337272 ↗ Treating Chronic Insomnia in Breast Cancer Patients Terminated Accelerated Community Oncology Research Network Phase 4 2006-08-01 This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
NCT00391755 ↗ A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Terminated Takeda Pharmaceuticals North America, Inc. Phase 4 2006-10-01 To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rozerem

Condition Name

Condition Name for Rozerem
Intervention Trials
Insomnia 13
Chronic Insomnia 7
Delirium 4
Bipolar Disorder 4
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Condition MeSH

Condition MeSH for Rozerem
Intervention Trials
Sleep Initiation and Maintenance Disorders 24
Disease 10
Delirium 5
Bipolar Disorder 4
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Clinical Trial Locations for Rozerem

Trials by Country

Trials by Country for Rozerem
Location Trials
United States 193
Russian Federation 5
Japan 4
United Kingdom 3
Germany 3
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Trials by US State

Trials by US State for Rozerem
Location Trials
California 13
Ohio 11
Florida 10
New York 9
Texas 8
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Clinical Trial Progress for Rozerem

Clinical Trial Phase

Clinical Trial Phase for Rozerem
Clinical Trial Phase Trials
Phase 4 21
Phase 3 12
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Rozerem
Clinical Trial Phase Trials
Completed 29
Terminated 9
Withdrawn 4
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Clinical Trial Sponsors for Rozerem

Sponsor Name

Sponsor Name for Rozerem
Sponsor Trials
Takeda 29
Takeda Pharmaceuticals North America, Inc. 4
Brigham and Women's Hospital 2
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Sponsor Type

Sponsor Type for Rozerem
Sponsor Trials
Industry 33
Other 29
U.S. Fed 4
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Rozerem (Ramelteon): Clinical Trials, Market Analysis, and Projections

Introduction to Rozerem (Ramelteon)

Rozerem, known generically as ramelteon, is a melatonergic agent used primarily for the treatment of insomnia, particularly for individuals who have difficulty falling asleep. It works by selectively binding to the MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN), mimicking the action of melatonin, the hormone that regulates the sleep-wake cycle[4].

Clinical Trials and Efficacy

Insomnia Treatment

Clinical trials have demonstrated the efficacy of Rozerem in treating insomnia characterized by difficulty with sleep onset. These trials, which lasted up to six months, showed significant improvements in sleep latency and overall sleep quality. The final formal assessments of sleep latency were performed at various intervals, including after two days, five weeks, and at the end of the six-month study[3].

Prevention of Delirium

Ramelteon has also been studied for its preventive effects on delirium, particularly in elderly patients and those in intensive care units (ICUs). A randomized controlled trial found that ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium. The study observed a significant reduction in the occurrence of delirium in the ramelteon group compared to the placebo group[1].

Another study conducted in an ICU setting showed that ramelteon tended to decrease the duration of ICU stay and statistically significantly decreased the occurrence rate and duration of delirium in ICU patients[5].

Adverse Events and Safety Profile

Clinical trials have identified several adverse events associated with Rozerem, including somnolence, dizziness, fatigue, nausea, headache, and insomnia. These events were generally mild and led to discontinuation in a small percentage of patients. Serious adverse reactions include severe anaphylactic and anaphylactoid reactions, abnormal thinking, behavior changes, and CNS effects[3].

Market Analysis

Market Size and Growth

The global market for insomnia medications, including Rozerem, is projected to reach approximately $6 billion by 2025, with a compound annual growth rate (CAGR) of 35.10% during the forecast period from 2024 to 2031. This growth is driven by increasing awareness of sleep disorders, rising stress levels, changing lifestyles, and the impact of technology on sleep quality[2].

Market Segmentation

The Ramelteon market is segmented into two main types: branded (Rozerem) and generic. Rozerem is the primary branded version, while the generic version offers a more cost-effective option for consumers. The market is also segmented by application, with key segments including hospitals and drug stores[4].

Regional Analysis

Regionally, the Ramelteon market is experiencing steady growth in North America and Europe, driven by government initiatives and increasing consumer awareness. The Asia-Pacific region, particularly China, leads the global market with robust domestic demand, supportive policies, and a strong manufacturing base[4].

Competitive Landscape

Key players in the Ramelteon market include Takeda Pharmaceuticals, the original marketer of Rozerem, and Dr. Reddy's Laboratories, which offers a generic version. Takeda Pharmaceuticals has a strong global presence and significant investments in research and development, contributing to its steady growth in the pharmaceutical sector[2].

Market Trends and Drivers

Increased Awareness of Sleep Disorders

Growing recognition of the importance of sleep health has surged demand for effective treatments, including Rozerem. Consumers are increasingly seeking solutions for insomnia, driving the market growth[2].

Digital Health Integration

The rise of sleep tracking apps and wearable technology provides insights into sleep patterns, fostering informed decisions about the use of Rozerem. This integration enhances patient adherence and market penetration[2].

Telehealth Growth

Remote consultations have expanded access to sleeping disorder treatments, driving prescriptions for Rozerem among patients who prefer avoiding in-person visits. This trend is particularly significant in the post-pandemic era[2].

Personalized Medicine

Advances in genetic profiling allow for tailored treatments, enhancing the efficacy and reducing the side effects of Rozerem for individual patients. This personalized approach is becoming increasingly popular in the healthcare sector[2].

Projections and Future Outlook

The future of the Rozerem market appears promising, with significant growth projected over the next several years. Here are some key projections:

  • Market Size: The global market for insomnia medications, including Rozerem, is expected to continue growing, reaching new heights by 2031.
  • Distribution and Access: Potential expansions in distribution channels and the introduction of new formulations are expected to enhance market access and patient adherence.
  • Technological Integration: Continued integration with digital health technologies and telehealth services will further drive the market.
  • Competitive Landscape: The market is expected to remain competitive, with key players like Takeda Pharmaceuticals and Dr. Reddy's Laboratories continuing to innovate and expand their offerings[2].

Key Takeaways

  • Clinical Efficacy: Rozerem has been shown to be effective in treating insomnia and preventing delirium in clinical trials.
  • Market Growth: The global market for Rozerem is projected to grow significantly, driven by increasing awareness of sleep disorders and technological advancements.
  • Regional Trends: The Asia-Pacific region, particularly China, is leading the global market, while North America and Europe also show steady growth.
  • Competitive Landscape: Key players are investing in research and development, and the market is expected to remain competitive.

FAQs

What is Rozerem used for?

Rozerem (ramelteon) is used for the treatment of insomnia characterized by difficulty falling asleep. It works by mimicking the action of melatonin, the hormone that regulates the sleep-wake cycle[3].

What are the common adverse events associated with Rozerem?

Common adverse events include somnolence, dizziness, fatigue, nausea, headache, and insomnia. Serious adverse reactions can include severe anaphylactic reactions and CNS effects[3].

How does Rozerem compare to other sleep aids?

Rozerem is a melatonergic agent that selectively binds to MT1 and MT2 receptors, avoiding the addictive potential associated with many traditional sleep aids like benzodiazepines[4].

What is the projected market size for Rozerem by 2025?

The global market for insomnia medications, including Rozerem, is projected to reach approximately $6 billion by 2025[2].

Who are the key players in the Rozerem market?

Key players include Takeda Pharmaceuticals, which markets Rozerem under the brand name Rozerem, and Dr. Reddy's Laboratories, which offers a generic version[2].

Sources

  1. JAMA Psychiatry: "Preventive Effects of Ramelteon on Delirium: A Randomized Controlled Trial"[1].
  2. OpenPR: "Ramelteon Market Share & Market Analysis - Growth Trends & Forecasts for period from (2024 - 2031)"[2].
  3. Takeda Pharmaceuticals: "ROZEREM (ramelteon) tablets, for oral use"[3].
  4. Global Info Research: "Global Ramelteon Market – Industry Reports"[4].
  5. Critical Care Medicine: "Effect of Administration of Ramelteon, a Melatonin Receptor Agonist, on the Duration of ICU Stay and the Occurrence Rate of Delirium in ICU Patients"[5].

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