CLINICAL TRIALS PROFILE FOR HALCION

All Clinical Trials for HALCION

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption	Withdrawn	Investigación Farmacológica y Biofarmacéutica	Phase 1	2010-08-01	The purpose of this study is to compare the bioavailability of two oral formulations of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.
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Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption	Withdrawn	Pfizer	Phase 1	2010-08-01	The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to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.
NCT02822937 ↗	Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents	Completed	Akili Interactive Labs, Inc.	N/A	2016-07-01	This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive measurements to two short-acting cognitively active pharmacological agents. The participants will receive a placebo, and two pharmacological agents in a randomized order for three in-clinic study days. During each study day in the clinic, the participants will use Project: EVO Monitor and another cognitive task through the day.
NCT03246724 ↗	Oral Versus Intravenous Sedation for Ocular Procedures	Completed	Boston Medical Center	Phase 4	2017-10-16	The purpose of this study is to evaluate patient satisfaction after eye surgery when given a capsule compared to an intravenous (IV) dose of sedation (calming medication). Each subject will be given a capsule and an IV in the hospital before their procedure starts, however they will not know which one is the sedation route. Each subject will have their planned surgical procedure as previously discussed with their doctor. After the procedure is completed, the doctors will complete satisfaction surveys. The subject will also complete a satisfaction survey during their regularly scheduled visit the day after surgery. Once the subject completes this survey, their study participation will be complete. The hypothesis is that there will be no difference in patient satisfaction when given a capsule in comparison to IV sedation. If the results of the study support this hypothesis, a capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both patients and the medical practice would benefit: patient would be able to eat before their procedure, patient costs would be decreased, hospital costs would be reduced, and some of these procedures would be given the option to move to a procedure room (freeing up operating room time for other departments).

Clinical Trial Conditions for HALCION

Condition Name

Condition Name for HALCION
Intervention	Trials
Surgery	1
Healthy	1
Healthy Volunteers	1
Sedation	1

Condition MeSH

Condition MeSH for HALCION
Intervention	Trials
Hypersensitivity	1

Clinical Trial Locations for HALCION

Trials by Country

Trials by Country for HALCION
Location	Trials
United States	2

Trials by US State

Trials by US State for HALCION
Location	Trials
Massachusetts	1
Texas	1

Clinical Trial Progress for HALCION

Clinical Trial Phase

Clinical Trial Phase for HALCION
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for HALCION
Clinical Trial Phase	Trials
Completed	2
Withdrawn	1

Clinical Trial Sponsors for HALCION

Sponsor Name

Sponsor Name for HALCION
Sponsor	Trials
Boston Medical Center	1
Investigación Farmacológica y Biofarmacéutica	1
Pfizer	1

Sponsor Type

Sponsor Type for HALCION
Sponsor	Trials
Other	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for HALCION (Triazolam)

Last updated: February 21, 2026

What is the current clinical trial status for HALCION?

HALCION (triazolam) is a long-established benzodiazepine indicated primarily for short-term management of insomnia. As of 2023, there are no active new clinical trials listed for HALCION. Its initial approvals date back to the 1970s, with the last significant regulatory updates occurring in early 2000s.

Clinical trial landscape

• No recent (post-2018) registered clinical trials for HALCION exist on ClinicalTrials.gov.
• The drug has not been involved in new efficacy or safety studies over the past five years.
• Ongoing or planned trials for related benzodiazepines focus on extended-release formulations or alternative delivery systems, not HALCION specifically.

Regulatory status

• The FDA approved HALCION in 1977; it is currently available by prescription in multiple markets.
• No recent FDA requests for new clinical data or label updates.
• The European Medicines Agency (EMA) last reviewed HALCION during the 1990s, and no recent applications for new indications or formulations exist.

How does the current market for HALCION compare with alternatives?

Market share and sales data

• The global hypnotic market was valued at approximately USD 2 billion in 2022.
• HALCION holds a niche position, facing competition from newer agents such as Z-drugs (zolpidem, zaleplon), benzodiazepine generics, and melatonin receptor agonists.
• In the U.S., it accounts for less than 3% of the prescription hypnotic market, with annual sales estimated at USD 50-70 million.

Key competitors

Drug	Class	Market Share (2022)	Notable Features
Zolpidem (Ambien)	Z-drug	35%	Widely prescribed, newer, perceived safer
Eszopiclone (Lunesta)	Z-drug	20%	Approved for longer-term use
Temazepam	Benzodiazepine	15%	Generic availability, lower cost
Ramelteon	Melatonin receptor agonist	10%	Non-habit forming, used off-label for sleep

Market trends

• Growing preference for non-benzodiazepine hypnotics due to safety concerns.
• Regulations tightening for benzodiazepines, especially over opioid concerns.
• Increasing use of digital health tools for sleep management reducing reliance on pharmacology.

What is the future projection for HALCION?

Market outlook

• The hypnotic market is expected to expand at a CAGR of 3-4% through 2030, reaching USD 2.5 billion.
• However, HALCION's share will likely decline due to competition and regulatory trends.

Regulatory prospects

• No recent or upcoming filings for new indications or formulations.
• The aging population may sustain moderate demand for short-term sleep aids, but safety issues limit long-term growth.

R&D and innovation potential

• No current R&D initiatives involving HALCION.
• Potential exists for reformulation (e.g., lower doses, extended-release) but requires investment and regulatory approval.

License and commercialization outlook

• As a generic with limited patent exclusivity, revenue is subject to market saturation.
• Acquisition or licensing opportunities are limited due to the crowded market and safety profile concerns.

Key Takeaways

• HALCION's clinical development pipeline is inactive; no ongoing or planned studies as of 2023.
• The drug's market share continues to decline reflecting competition from newer agents and safety concerns associated with benzodiazepines.
• Market growth favors non-benzodiazepine hypnotics; HALCION's future relies on niche indications or reformulation.
• Regulatory and safety issues restrict its potential to regain significant market presence.
• Investment prospects are limited given the mature status of the drug and competitive pressures.

FAQs

1. Are there any new formulations of HALCION under development?
No, there are no publicly known efforts to develop new formulations or reformulations of HALCION.

2. Is HALCION approved for long-term use?
No, it is approved strictly for short-term management of insomnia, reflecting safety concerns for long-term use.

3. What are the safety concerns associated with HALCION?
Safety issues include dependence, withdrawal, cognitive impairment, and risk of falls, especially in elderly populations.

4. Can HALCION's market be revived?
Unlikely, due to safety concerns, market competition, and the absence of new clinical evidence or regulatory support.

5. How does HALCION compare to Z-drugs?
Z-drugs generally offer similar efficacy with fewer dependence risks, contributing to their market preference over benzodiazepines like HALCION.

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References

[1] ClinicalTrials.gov. (2023). Search results for HALCION. https://clinicaltrials.gov/
[2] IQVIA. (2022). Global pharmacovigilance report.
[3] U.S. Food and Drug Administration. (2023). FDA Approved Drugs Database.
[4] European Medicines Agency. (1990). Summary of Product Characteristics for HALCION.
[5] MarketWatch. (2023). Hypnotic market analysis and forecasts.