CLINICAL TRIALS PROFILE FOR TRAZODONE HYDROCHLORIDE

All Clinical Trials for Trazodone Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000179 ↗	Agitation in Alzheimer's Disease	Completed	National Institute on Aging (NIA)	Phase 3	1969-12-31	Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.
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.

Clinical Trial Conditions for Trazodone Hydrochloride

Condition Name

Condition Name for Trazodone Hydrochloride
Intervention	Trials
Insomnia	9
Healthy	6
Major Depressive Disorder	5
Depression	5

Condition MeSH

Condition MeSH for Trazodone Hydrochloride
Intervention	Trials
Sleep Initiation and Maintenance Disorders	15
Depression	13
Sleep Apnea Syndromes	10
Sleep Apnea, Obstructive	9

Clinical Trial Locations for Trazodone Hydrochloride

Trials by Country

Trials by Country for Trazodone Hydrochloride
Location	Trials
United States	118
Canada	14
Switzerland	4
China	4
Germany	3

Trials by US State

Trials by US State for Trazodone Hydrochloride
Location	Trials
California	11
Pennsylvania	8
New York	8
Massachusetts	7
Georgia	5

Clinical Trial Progress for Trazodone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Trazodone Hydrochloride
Clinical Trial Phase	Trials
PHASE4	5
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Trazodone Hydrochloride
Clinical Trial Phase	Trials
Completed	36
Recruiting	14
Not yet recruiting	9

Clinical Trial Sponsors for Trazodone Hydrochloride

Sponsor Name

Sponsor Name for Trazodone Hydrochloride
Sponsor	Trials
VA Office of Research and Development	6
Aziende Chimiche Riunite Angelini Francesco S.p.A	6
Labopharm Inc.	5

Sponsor Type

Sponsor Type for Trazodone Hydrochloride
Sponsor	Trials
Other	72
Industry	25
NIH	14

Trazodone Hydrochloride: Clinical Trials Update, Market Analysis, and Projections

Last updated: April 27, 2026

What is trazodone hydrochloride and how is it used in markets?

Trazodone hydrochloride is an oral antidepressant used off-label for insomnia in many jurisdictions and is also used for major depressive disorder. Commercially, it is widely established and primarily accessed as a generic product in most markets, which constrains pricing power and shifts growth to volume, channel mix, and payer dynamics.

Key commercialization context:

• Molecular identity: Trazodone (hydrochloride salt used for formulation).
• Therapeutic positioning: Antidepressant; frequently used for sleep-related symptoms in practice (labeling varies by country).
• Competitive structure: Generic-heavy; differentiation is usually formulation, dosing convenience, and managed-care access rather than patent-protected molecules.

Where do clinical trials stand for trazodone hydrochloride?

A targeted, molecule-specific “clinical trials update” depends on the latest trial registry entries and study-level disclosures (phase, design, endpoints, enrollment status). The provided input does not include trial identifiers, registries, or dated study results, so a complete and accurate, up-to-date trial landscape cannot be produced under the operating constraints.

Clinical trial status by phase (cannot be completed)

No defensible, source-backed phase-by-phase count, timeline, or readout status can be delivered from the current prompt.

What is the commercial market structure for trazodone hydrochloride?

Because trazodone hydrochloride is broadly available as generic medication, the market behaves differently from late-stage branded specialty drugs:

• Pricing: Typically driven down by generic competition and reference pricing.
• Demand: More stable, tied to prevalence of depression and insomnia and to formulary access.
• Growth drivers: Treatment penetration, persistence (duration of use), and shift from other sleep agents based on payer policies and clinician preference.
• Risks: Entrenched generic share and low incremental differentiation.

Market mechanics that matter for forecasts

1. Generic price erosion: Ongoing margin compression is typical as competitors expand or as supply improves.
2. Formulary rules: Step therapy and prior authorization for antidepressants or insomnia treatment can change net demand.
3. Safety and tolerability perceptions: Sedation and orthostatic hypotension concerns affect switching behavior.
4. Substitution pressure: New sedative-hypnotic and antidepressant generics can pull share.

How large is the trazodone hydrochloride market and what does that imply for projections?

The prompt does not provide numeric market size, geography, or dataset sources. Under the operating constraints, a “market analysis and projection” with hard numbers (market value, CAGR, shares, and forecast horizon) cannot be completed without cited figures.

Forecasting framework (what a complete projection would require)

A defensible projection would typically include:

• Historical sales by geography and channel (retail, mail order, hospital)
• Gross-to-net adjustments (rebates, discounts)
• Generic entry and subsequent price indices
• Utilization and persistence models by indication proxy
• Scenario analysis around formulary inclusion changes

No such quantified inputs or citations are provided in the request.

What are the main commercial opportunities and downside risks?

Even without quantified market sizing, a structured risk and opportunity set can be grounded in known generic-market behavior, but the prompt asks for an “update” and “projection.” Without source-backed trial and market data, only non-quantified statements are possible, which are not sufficient for the requested deliverable.

Opportunities (generic-market realities)

• Expanded formulary coverage for depression and insomnia symptom management
• Improved adherence via dosing convenience and tolerability-oriented formulations
• Sustained baseline demand due to chronic and recurrent use patterns in depression/sleep symptom cohorts

Downside risks

• Continued price compression from multiple generics
• Competitive substitution from other off-label insomnia agents and antidepressants
• Prescribing shifts tied to safety communications or local practice guidelines

Decision-grade outlook: what can be concluded from the information provided?

A “clinical trials update” and a numeric “market analysis and projection” cannot be produced accurately from the current prompt. The deliverable requires registry-level evidence (trial status, dates, and results) and market datasets (current sales and forecast drivers) with citations. The prompt provides neither.

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Key Takeaways

• Trazodone hydrochloride is a mature, generic-dominated antidepressant with common off-label insomnia use in practice.
• A source-backed clinical trials update cannot be completed from the provided information.
• A source-backed market analysis and projection cannot be completed from the provided information.

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FAQs

1) Is trazodone hydrochloride still actively studied in clinical trials?

A molecule-specific, registry-verified update is not possible with the current prompt content.

2) What drives growth for generic trazodone hydrochloride?

Growth typically comes from formulary access, utilization, and net pricing dynamics rather than patent-protected innovation, but no quantified drivers are provided here.

3) What are the biggest market risks for trazodone hydrochloride?

Ongoing generic price erosion and substitution by competing therapies are primary risks, but no market-specific forecast is provided.

4) Which therapeutic area accounts for most demand?

Depression and off-label insomnia symptom management are common demand drivers, but no sales split is provided here.

5) Can a reliable forecast be produced without numeric inputs?

No. A projection requires historical sales/utilization data and source-backed assumptions, which are absent from the prompt.

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References

1. No sources were provided in the prompt.