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).

Clinical Trial Conditions for Triazolam

Condition Name

Condition Name for Triazolam
Intervention	Trials
Healthy	4
Anxiety	2
Sedation	2
Dental Anxiety	2

Condition MeSH

Condition MeSH for Triazolam
Intervention	Trials
Somatoform Disorders	1
Dissociative Disorders	1
Multiple Myeloma	1
Vitreous Detachment	1

Clinical Trial Locations for Triazolam

Trials by Country

Trials by Country for Triazolam
Location	Trials
United States	9
Belgium	2
Germany	1
Switzerland	1
Canada	1

Trials by US State

Trials by US State for Triazolam
Location	Trials
Pennsylvania	1
Massachusetts	1
Texas	1
Georgia	1
Florida	1

Clinical Trial Progress for Triazolam

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Triazolam
Clinical Trial Phase	Trials
Completed	13
Not yet recruiting	3
Unknown status	1

Clinical Trial Sponsors for Triazolam

Sponsor Name

Sponsor Name for Triazolam
Sponsor	Trials
Pfizer	3
University of Pittsburgh	1
Saint-Joseph University	1

Sponsor Type

Sponsor Type for Triazolam
Sponsor	Trials
Other	25
Industry	8
NIH	1

Triazolam: Clinical Trials, Market Analysis, and Projections

Introduction

Triazolam, known by its brand name Halcion, is a short-acting benzodiazepine used primarily for the short-term treatment of insomnia. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Efficacy in Insomnia Treatment

Clinical trials have consistently shown that triazolam is effective in treating insomnia. A multi-clinic double-blind study involving 239 patients treated with either triazolam 0.5 mg or a placebo for 14 days demonstrated that triazolam significantly improved sleep parameters, including onset of sleep, duration of sleep, and the number of nocturnal awakenings. The study also found that triazolam did not lead to tolerance development after two weeks of treatment[3].

Rebound Anxiety and Long-Term Use

A double-blind, placebo-controlled study examining the effects of triazolam over five weeks found no evidence of rebound anxiety during or after the treatment period. This study used the Profile of Mood States (POMS) to assess anxiety levels and concluded that triazolam did not increase anxiety in patients with moderate levels of psychopathology and prior use of hypnotics[4].

Drug Interactions and Safety

CYP 3A Inhibitors

Triazolam's metabolism is significantly affected by CYP 3A inhibitors. Drugs such as ketoconazole, itraconazole, nefazodone, and several HIV protease inhibitors (e.g., ritonavir, indinavir) should not be used concomitantly with triazolam due to the risk of increased plasma concentrations and prolonged half-life of triazolam. Other drugs like macrolide antibiotics (e.g., erythromycin, clarithromycin), cimetidine, and grapefruit juice also interact with triazolam, necessitating caution and potential dose reduction[1].

Common Side Effects

Common side effects of triazolam include drowsiness, grogginess, headaches, impaired coordination, nausea, and dizziness. These side effects are similar to those observed with other benzodiazepines and highlight the need for careful patient monitoring and appropriate dosing[3].

Market Analysis

Global Market Size and Growth

The global triazolam market is expected to experience robust expansion. According to market research reports, the triazolam market is projected to register a significant CAGR in terms of revenue over the next few years, with the global market size expected to reach a substantial value by 2024. This growth is driven by increasing demand for sleep aids and the expanding global healthcare market[2].

Key Players

The triazolam market is dominated by several key players, including Pfizer, Novartis, Nhwa-group, Merck, Sanofi, Gilead Sciences, and Teva. These companies play a crucial role in the production, distribution, and marketing of triazolam, influencing market trends and competition[2].

Market Segmentation

The triazolam market is segmented by type (e.g., 0.25mg/Pcs, 0.125mg/Pcs) and by application (e.g., adults, older adults, children). This segmentation helps in understanding the specific needs and preferences of different patient groups and regions, such as North America, Europe, China, and Japan[2].

Projections and Future Outlook

Market Expansion

The triazolam market is anticipated to continue its growth trajectory, driven by the increasing prevalence of insomnia and other sleep disorders. The market is expected to benefit from advancements in healthcare infrastructure and the rising awareness of sleep health[2].

Regulatory Considerations

Despite its efficacy, triazolam has faced regulatory scrutiny in the past due to concerns about adverse reactions, particularly at higher doses. However, its use at lower doses with appropriate labeling and caution has been reaffirmed by regulatory bodies like the FDA. This careful regulatory oversight is expected to continue, ensuring the safe use of triazolam[5].

Key Takeaways

• Efficacy: Triazolam is effective in treating insomnia, improving various sleep parameters without leading to tolerance development.
• Drug Interactions: Caution is necessary when coadministering triazolam with CYP 3A inhibitors and other interacting drugs.
• Market Growth: The global triazolam market is projected to experience significant growth driven by increasing demand for sleep aids.
• Key Players: Major pharmaceutical companies dominate the market, influencing production, distribution, and marketing.
• Regulatory Considerations: Regulatory bodies continue to monitor the use of triazolam, ensuring its safe and effective use.

FAQs

What is triazolam used for?

Triazolam is used for the short-term treatment of insomnia.

What are the common side effects of triazolam?

Common side effects include drowsiness, grogginess, headaches, impaired coordination, nausea, and dizziness.

Which drugs should not be used concomitantly with triazolam?

Drugs that are potent CYP 3A inhibitors, such as ketoconazole, itraconazole, and several HIV protease inhibitors, should not be used concomitantly with triazolam.

How does triazolam affect sleep parameters?

Triazolam significantly improves sleep parameters, including onset of sleep, duration of sleep, and the number of nocturnal awakenings.

What is the projected growth of the triazolam market?

The global triazolam market is expected to register a significant CAGR in terms of revenue over the next few years, driven by increasing demand for sleep aids.

Who are the key players in the triazolam market?

Key players include Pfizer, Novartis, Nhwa-group, Merck, Sanofi, Gilead Sciences, and Teva.

Sources

1. HALCION (TRIAZOLAM) Label - accessdata.fda.gov
2. Triazolam Market to Witness Robust Expansion by 2025 - openpr.com
3. Multi-clinic double-blind comparison of triazolam (Halcion ... - PubMed
4. Profile of mood states changes during and after 5 weeks of nightly ... - PubMed
5. Triazolam: Uses, Interactions, Mechanism of Action | DrugBank Online - go.drugbank.com