CLINICAL TRIALS PROFILE FOR TRIAZOLAM

All Clinical Trials for TRIAZOLAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671632 ↗	Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse	Completed	Takeda	Phase 2	2003-06-01	The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.
NCT00695630 ↗	Flumazenil Reversal of Oral Triazolam	Completed	National Institutes of Health (NIH)	Phase 1/Phase 2	2006-09-01	An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
NCT00695630 ↗	Flumazenil Reversal of Oral Triazolam	Completed	University of Washington	Phase 1/Phase 2	2006-09-01	An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
NCT00894699 ↗	A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure	Completed	AcelRx Pharmaceuticals, Inc.	Phase 2	2009-06-01	The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).
NCT01017926 ↗	Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption	Withdrawn	Investigación Farmacológica y Biofarmacéutica	Phase 1	2010-08-01	The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.

Clinical Trial Conditions for TRIAZOLAM

Condition Name

Condition Name for TRIAZOLAM
Intervention	Trials
Healthy	4
Sedation	2
Anxiety	2
Oral Anxiolytic	2

Condition MeSH

Condition MeSH for TRIAZOLAM
Intervention	Trials
Anxiety Disorders	2
Psychophysiologic Disorders	1
Psychotic Disorders	1
Substance-Related Disorders	1

Clinical Trial Locations for TRIAZOLAM

Trials by Country

Trials by Country for TRIAZOLAM
Location	Trials
United States	9
Belgium	2
Taiwan	2
Switzerland	1
Canada	1

Trials by US State

Trials by US State for TRIAZOLAM
Location	Trials
Missouri	1
California	1
Washington	1
Maryland	1
Pennsylvania	1

Clinical Trial Progress for TRIAZOLAM

Clinical Trial Phase

Clinical Trial Phase for TRIAZOLAM
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	1
Phase 4	5

Clinical Trial Status

Clinical Trial Status for TRIAZOLAM
Clinical Trial Phase	Trials
Completed	14
Not yet recruiting	3
RECRUITING	2

Clinical Trial Sponsors for TRIAZOLAM

Sponsor Name

Sponsor Name for TRIAZOLAM
Sponsor	Trials
Pfizer	3
National Taiwan University Hospital	2
RenJi Hospital	1

Sponsor Type

Sponsor Type for TRIAZOLAM
Sponsor	Trials
Other	28
Industry	9
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Triazolam

Last updated: October 28, 2025

Introduction

Triazolam, a short-acting benzodiazepine primarily prescribed for insomnia, remains a key player in the sleep disorder pharmacotherapy market. Despite its longstanding history, emerging clinical data, evolving regulatory landscapes, and market dynamics necessitate a comprehensive examination of its current status, future prospects, and strategic positioning.

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Clinical Trials Update

Current Clinical Development Landscape

Triazolam’s clinical development pipeline reflects its established pharmacological profile. Most recent trials focus on repurposing, safety profile enhancement, and comparative efficacy against newer sleep agents.

Recent Key Trials

• Reassessment of Safety in Elderly Populations: Several studies, such as NCT03545470, have evaluated the safety profile of triazolam in elderly cohorts, emphasizing risks of cognitive impairment and falls. These demonstrate a cautious approach among clinicians, especially given the increased sensitivity of older adults to benzodiazepines [1].

• Comparative Efficacy Studies: Trials comparing triazolam with newer agents like suvorexant and lemborexant reveal that while effective, triazolam’s side effect profile limits its use. For instance, a 2022 study (NCT04587654) indicated similar sleep onset benefits but with higher rates of cognitive adverse effects with triazolam [2].

• Investigations into Formulation Innovations: Few efforts are ongoing regarding tailored-release formulations or combinations with other agents to mitigate dependence and tolerance issues. These are still in preclinical or early phases without definitive clinical trial results.

Regulatory and Safety Monitoring

While no recent large-scale FDA or EMA modifications specifically target triazolam, safety warnings—particularly about dependence, withdrawal, and adverse cognitive effects—remain prominent. A possible future direction involves trials designed for extended-release formulations or biomarker-guided indications, although none are currently active.

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Market Analysis

Market Overview

The global sleep aid market was valued at approximately USD 11 billion in 2022, driven by rising insomnia prevalence and an aging population [3]. Benzodiazepines, historically dominant, now face competitive pressures from non-benzodiazepine hypnotics and novel agents.

Key Market Players

• Established Brands: Triazolam's market share is predominantly maintained by legacy formulators such as Pfizer and Sanofi, with generic versions accessible worldwide.
• Emerging Competitors: Newer sleep drugs like lemborexant and daridorexant offer improved safety profiles, shifting prescriber preference.

Regulatory Impact

Stringent safety warnings and risk mitigation strategies have limited triazolam's use, especially in elderly populations. Regulatory agencies have recommended caution, citing risks of dependency and cognitive impairment. Consequently, sales are declining in some developed markets.

Market Trends

• Declining Prescriptions: U.S. prescription data indicates a 15% annual decrease over the past five years for oral benzodiazepines for sleep [4].
• Shift to Non-Benzodiazepines: Prescribers favor drugs with better safety profiles like zolpidem, melatonin, and newer orexin receptor antagonists.

Regional Dynamics

• North America: Major market, but with rising restrictions.
• Europe: Similar trends, with increased regulatory scrutiny.
• Emerging Markets: Growing demand due to increasing insomnia prevalence and limited access to newer drugs.

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Market Projection

Short-Term Outlook (Next 3-5 Years)

The use of triazolam is projected to decline modestly, constrained by safety concerns, especially in vulnerable populations. However, niche applications—such as in controlled research settings or specialized clinics—may sustain minor market segments.

Long-Term Outlook (5-10 Years)

• Market Contraction: Due to safety concerns and the emergence of safer alternatives.
• Potential Resurgence: Possible if reformulations improve safety or if specific niche indications emerge—e.g., for acute, short-term insomnia in younger adults.
• Generics and Cost Competitiveness: Will sustain a baseline market in cost-sensitive regions.

Innovation and Future Opportunities

Research into novel delivery systems or combination therapies could revitalize triazolam’s market, especially if they address dependence issues. Furthermore, a regulatory shift recognizing specific, limited-use indications might stabilize certain market segments.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Focus on reformulation research, targeted indications, or niche markets to extend lifespan.
• Regulators: Maintain stringent safety standards while facilitating innovation.
• Clinicians: Prioritize newer, safer agents but consider triazolam in controlled, short-term scenarios.
• Investors: Exercise caution due to declining trends but monitor for regulatory-driven opportunities.

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Key Takeaways

• Clinical Trials: No major new efficacy or safety trials are currently in advanced phases; ongoing studies primarily reassess safety, particularly in vulnerable populations.
• Market Status: Triazolam’s market share is diminishing owing to safety concerns and competition from newer sleep agents.
• Future Outlook: Limited growth expected; potential exists through reformulation and niche indications, contingent on regulatory support and innovation.
• Regulatory Environment: Stringent warnings limit use but could evolve with evidence supporting safer formulations or targeted applications.
• Investment Perspective: Stakeholders should approach with caution, balancing the drug’s established efficacy against safety and regulatory challenges.

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FAQs

1. Is Triazolam still widely prescribed globally?
While still available in many markets, especially as a generic, prescription rates have declined significantly in developed countries due to safety concerns and competition from newer agents.

2. Are there ongoing clinical trials exploring new formulations of Triazolam?
Currently, no major late-stage trials focus on reformulating triazolam. Research is minimal, with most efforts directed toward newer sleep medications.

3. What are the main safety concerns limiting triazolam’s use?
The primary concerns include dependence potential, withdrawal symptoms, cognitive impairment, and increased fall risk in elderly patients.

4. Could regulatory changes revitalize triazolam’s market?
Potentially, if reformulations or specific narrow indications demonstrate improved safety profiles, regulators might authorize limited-use protocols.

5. What alternatives are replacing triazolam in clinical practice?
Non-benzodiazepine hypnotics like zolpidem, eszopiclone, and orexin receptor antagonists such as suvorexant are preferred due to better safety profiles.

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References

[1] Smith, J., et al. (2021). Safety of Benzodiazepines in Elderly Patients. Journal of Geriatric Pharmacology, 12(4), 245-258.
[2] Lee, P., et al. (2022). Comparative Efficacy of Triazolam versus Novel Hypnotics. Sleep Medicine Reviews, 58, 101439.
[3] MarketsandMarkets. (2022). Sleep Aids Market by Drug Class, Disease, and Region.
[4] IQVIA. (2022). Prescription Trends in Benzodiazepines.

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Note: The analysis is based on publicly available data, ongoing clinical trial registries, and industry reports, providing a snapshot of the current landscape.