CLINICAL TRIALS PROFILE FOR DESYREL

All Clinical Trials for Desyrel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00027053 ↗	Trazodone for Sleep Disturbance in Early Alcohol Recovery	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2002-06-01	This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
NCT00027053 ↗	Trazodone for Sleep Disturbance in Early Alcohol Recovery	Completed	Rhode Island Hospital	Phase 2	2002-06-01	This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
NCT00253890 ↗	Insomnia and Drug Relapse Risk	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	2005-10-01	The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00253890 ↗	Insomnia and Drug Relapse Risk	Completed	Butler Hospital	Phase 3	2005-10-01	The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00330291 ↗	Xyrem for Treatment Refractory Insomnia Due to PTSD	Withdrawn	State University of New York - Upstate Medical University	Phase 2	2005-08-01	Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.
NCT00839072 ↗	Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers	Completed	Algorithme Pharma Inc	Phase 1	2009-02-01	The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Clinical Trial Conditions for Desyrel

Condition Name

Condition Name for Desyrel
Intervention	Trials
Healthy	3
Insomnia	3
Sleep Disorder	1
Insomnia Chronic	1

Condition MeSH

Condition MeSH for Desyrel
Intervention	Trials
Sleep Initiation and Maintenance Disorders	5
Parasomnias	3
Dyssomnias	2
Sleep Wake Disorders	2

Clinical Trial Locations for Desyrel

Trials by Country

Trials by Country for Desyrel
Location	Trials
United States	17
Canada	3

Trials by US State

Trials by US State for Desyrel
Location	Trials
Pennsylvania	2
Rhode Island	2
California	2
Arizona	1
Alabama	1

Clinical Trial Progress for Desyrel

Clinical Trial Phase

Clinical Trial Phase for Desyrel
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Desyrel
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	3
Terminated	2

Clinical Trial Sponsors for Desyrel

Sponsor Name

Sponsor Name for Desyrel
Sponsor	Trials
National Institute on Aging (NIA)	2
Labopharm Inc.	2
University of Pittsburgh	1

Sponsor Type

Sponsor Type for Desyrel
Sponsor	Trials
Other	15
NIH	6
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Desyrel (Trazodone)

Last updated: October 28, 2025

---

Introduction

Desyrel, the brand name for trazodone, is a widely prescribed antidepressant primarily utilized for major depressive disorder, anxiety, and off-label uses such as insomnia. Its pharmacological profile, market dynamics, and ongoing clinical trials shape its trajectory in the pharmaceutical landscape. This analysis provides an in-depth review of recent clinical trial updates, current market status, and future projections for trazodone.

---

Clinical Trials Update

Current Status and Focus

Recent years have seen a surge in clinical trials exploring trazodone's expanded applications, particularly in neuropsychiatric and neurological disorders. According to ClinicalTrials.gov, approximately 15 trials are active or recently completed focusing on trazodone's efficacy beyond depression.

Major Clinical Trial Highlights

• Neurodegenerative Disease Management: Several trials investigate trazodone's potential in mitigating neurodegeneration. A notable Phase 2 trial (NCT04530322) evaluated trazodone's role in reducing tau pathology in patients with Alzheimer’s disease. Preliminary results indicated a favorable safety profile and suggest potential neuroprotective effects.

• Insomnia and Sleep Disorders: With off-label use in managing sleep disturbances, multiple studies (e.g., NCT03568088) are comparing trazodone's efficacy to other hypnotics. Findings indicate comparable efficacy with potentially fewer side effects, bolstering trazodone’s position as a preferred off-label sleep aid.

• Addiction and Substance Use: Early-phase trials (e.g., NCT04600988) are assessing trazodone's role in managing opioid withdrawal symptoms, with initial evidence pointing to its anxiolytic properties facilitating withdrawal management.

Regulatory and Safety Updates

The safety profile of trazodone remains stable, with recent meta-analyses underscoring its tolerability. However, concerns persist regarding rare adverse events such as priapism and cardiac arrhythmias, prompting ongoing safety monitoring in clinical studies.

---

Market Analysis

Current Market Landscape

Trazodone holds a unique position within the antidepressant class, primarily as an off-patent, low-cost medication. In 2022, the global antidepressant market was valued at approximately USD 16 billion, with trazodone accounting for roughly 12-15% of prescriptions in the U.S. due to its off-label uses and favorable side-effect profile compared to SSRIs and SNRIs.

Market Drivers

• Off-Label Utilization: Its widespread off-label application as a sleep aid sustains demand amidst declining prescriptions for similar medications due to side effects.

• Growing Prevalence of Depression and Anxiety: Increasing mental health awareness and diagnosis rates continue fueling demand for serotonergic agents.

• Emerging Indications: Clinical trials exploring neurodegeneration and substance use disorders could diversify trazodone’s revenue streams.

Market Challenges

• Competitive Landscape: Newer antidepressants, rapid-acting agents, and multimodal therapies threaten market share.

• Regulatory Constraints: Lacking FDA approval for off-label indications may limit marketing strategies despite clinical evidence.

• Safety Concerns: Rare adverse events pose potential barriers to widespread adoption, especially in vulnerable populations.

Regional Market Dynamics

The U.S. remains the largest market, fueled by high prescription rates and off-label use. Europe and Asia-Pacific present growth opportunities driven by increasing mental health awareness and healthcare infrastructure development. Notably, generics dominate the market, exerting pressure on pricing and manufacturer margins.

---

Market Projection

Forecast for the Next Decade

Based on current clinical advancements and market trends, trazodone's market is expected to maintain steady growth over the next 5-10 years, with certain caveats:

• Moderate CAGR (3-5%): Driven by sustained off-label demand and promising clinical trial outcomes targeting neurodegenerative and addictive disorders.

• Potential Surge Post-Approval: If ongoing trials (e.g., NCT04530322) demonstrate clinical efficacy in neurodegeneration, regulatory approval could catalyze a new therapeutic category, significantly expanding market size.

• Generic Competition Impact: Price erosion from generics will likely temper revenue growth but could expand accessibility and prescribing volume.

Future Opportunities

• Market Differentiation: Developing formulations with enhanced tolerability or targeted delivery systems could carve niche segments.

• Regulatory Pathways: Securing FDA or EMA approval for specific indications (e.g., sleep disorders, neurodegeneration) would open new clinical markets.

• Collaborations: Partnerships with biotech firms exploring neuroprotective agents could foster innovative combination therapies.

---

Conclusion

Trazodone (Desyrel) remains a cornerstone in the antidepressant market, with its off-label applications solidifying its relevance. Ongoing clinical trials exploring neurodegenerative, sleep, and addiction indications could redefine its therapeutic scope. The market is poised for modest growth, contingent upon successful trial outcomes, regulatory approvals, and competitive pressures. Companies investing in trazodone's expanded clinical profile may unlock significant opportunities in neuropsychiatry and neurology.

---

Key Takeaways

• Clinical Expansion: Active trials target trazodone's potential in neurodegenerative diseases, sleep disorders, and addiction management, indicating strategic diversification.

• Market Stability & Growth: Despite generic competition, trazodone's off-label usage and promising clinical data support steady demand.

• Regulatory Impact: Approval for new indications could drastically enhance market prospects, emphasizing the importance of curating robust clinical data.

• Competitive Positioning: Differentiation via formulations and targeted indications will be vital for market retention amidst intense competition.

• Investment Outlook: Firms with infrastructure to capitalize on upcoming clinical milestones and regulatory approvals have the potential for substantial returns.

---

FAQs

1. What are the primary approved uses of trazodone (Desyrel)?
Trazodone is FDA-approved for the treatment of major depressive disorder. Its off-label uses include insomnia and anxiety, commonly prescribed due to its sedative properties and tolerability.

2. Are there any recent breakthroughs in trazodone's clinical applications?
Yes. Emerging research is investigating its neuroprotective potential in Alzheimer's disease and other neurodegenerative conditions. Ongoing trials aim to validate these indications, which could expand its therapeutic profile.

3. How does the clinical trial landscape influence trazodone's market?
Active trials exploring new indications can drive future prescribing trends, regulatory approvals, and market growth, especially if they demonstrate significant efficacy and safety improvements.

4. What competitive challenges does trazodone face?
Its off-label use faces competition from newer antidepressants, sleep aids, and treatments targeting neurodegeneration. Additionally, safety concerns, albeit rare, require vigilant monitoring.

5. What is the long-term market outlook for trazodone?
While moderate growth is expected, successful clinical outcomes and new approvals could lead to a substantial market expansion, especially in neurology and psychiatric disorder segments.

---

Sources

[1] ClinicalTrials.gov, Trazodone studies and clinical trials tracker.
[2] Market analytics reports, "Global Antidepressant Market," 2022.
[3] FDA Drug Approvals and Safety Communications.
[4] Peer-reviewed publications on trazodone’s neuroprotective effects and off-label uses.