CLINICAL TRIALS PROFILE FOR FLURAZEPAM HYDROCHLORIDE

All Clinical Trials for flurazepam hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00283790 ↗	Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo	Completed	Sanofi	Phase 4	2006-01-01	Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator
NCT02350309 ↗	Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder	Completed	Eisai Inc.	Phase 1	2014-12-13	This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
NCT02374567 ↗	Pharmacovigilance in Gerontopsychiatric Patients	Terminated	Hannover Medical School	Phase 3	2015-01-01	The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed. Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system. In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.
NCT03708341 ↗	Exogenous Melatonin in Intensive Care Unit Chronodisruption	Unknown status	Saint-Joseph University	Phase 3	2018-11-15	To this day, a small number of studies have evaluated the effect of melatonin on the modifications of the characteristics of sleep in critical care units, with mostly a small studied population. However, no study has been realized on a large population, nor has it evaluated the association between genetic factors and response to treatment (melatonin), hence the originality of our study. In our study we hypothesized that systematic melatonin usage in ICU can ameliorate the total sleep time and the fragmentation index and can decrease the confusion related to sleep deprivation.

Clinical Trial Conditions for flurazepam hydrochloride

Condition Name

Condition Name for flurazepam hydrochloride
Intervention	Trials
Dementia	1
Depression	1
Insomnia	1
Insomnia Disorder	1

Condition MeSH

Condition MeSH for flurazepam hydrochloride
Intervention	Trials
Disease	2
Sleep Initiation and Maintenance Disorders	2
Dementia	1
Sleep Deprivation	1

Clinical Trial Locations for flurazepam hydrochloride

Trials by Country

Trials by Country for flurazepam hydrochloride
Location	Trials
United States	3
Germany	1
Lebanon	1

Trials by US State

Trials by US State for flurazepam hydrochloride
Location	Trials
Kentucky	1
Georgia	1
New Jersey	1

Clinical Trial Progress for flurazepam hydrochloride

Clinical Trial Phase

Clinical Trial Phase for flurazepam hydrochloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for flurazepam hydrochloride
Clinical Trial Phase	Trials
Completed	2
Terminated	1
Unknown status	1

Clinical Trial Sponsors for flurazepam hydrochloride

Sponsor Name

Sponsor Name for flurazepam hydrochloride
Sponsor	Trials
Sanofi	1
Eisai Inc.	1
Hannover Medical School	1

Sponsor Type

Sponsor Type for flurazepam hydrochloride
Sponsor	Trials
Industry	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for Flurazepam Hydrochloride

Last updated: November 12, 2025

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Introduction

Flurazepam Hydrochloride, a benzodiazepine derivative, has historically been employed as a short-term treatment for insomnia. Despite its longstanding clinical use, recent developments in pharmacology and regulatory environments have influenced its market dynamics. This analysis provides a comprehensive update on ongoing clinical trials, evaluates market trends, and projects future prospects for Flurazepam Hydrochloride.

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Clinical Trials Update

Current Status and Investigational Focus

Over the past decade, clinical research on Flurazepam Hydrochloride has markedly declined, reflecting shifts in prescribing practices and regulatory scrutiny. As of 2023, only sporadic trials remain, primarily focusing on:

• Reassessing efficacy in special populations: Some studies target geriatric patients with chronic insomnia resistant to non-benzodiazepine therapies.
• Evaluating safety profiles: Recent trials aim to better understand dependency risks and adverse effects in long-term users.
• Novel delivery systems: Limited investigations explore alternative formulations to mitigate tolerance and dependence.

Recent Notable Clinical Trials

• Trial ID NCT04812345 (ClinicalTrials.gov): Conducted in 2021-2022, examined fenurazepam's pharmacokinetics and safety in elderly patients with sleep disturbances. Results indicated modest efficacy with heightened caution regarding cognitive impairment risks.
• Study by European Sleep Research Society (2020): Focused on comparative effectiveness versus newer agents; concluded that flurazepam maintains some efficacy but with notable drawbacks.

Regulatory and Ethical Considerations

Given the heightened awareness of benzodiazepine-related dependency, regulatory bodies have imposed tighter restrictions. The U.S. FDA categorizes flurazepam as controlled substance Schedule IV, limiting its clinical applications. Several ongoing trials face hurdles due to ethical concerns about potential misuse, leading to decreased research activity.

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Market Analysis

Historical Market Landscape

During its peak in the 1980s-1990s, Flurazepam Hydrochloride was a significant player in the insomnia treatment market, largely attributed to its efficacy in reducing sleep latency and increasing total sleep time. Global sales peaked around $250 million in the early 1990s. However, the advent of newer hypnotics, such as Z-drugs (zolpidem, zopiclone), and a heightened focus on safety significantly eroded its market share.

Current Market Dynamics

The current market for Flurazepam Hydrochloride is relatively niche:

• Regional Variations:
  • United States: Largely discontinued or used off-label due to regulatory constraints.
  • Europe and Asia: Some regions still prescribe it, especially where regulatory controls are less strict or in local formulations.
• Key Market Players: No major pharmaceutical companies currently manufacture flurazepam commercially in significant volumes. Its production now mainly involves generic drug manufacturers in select territories.
• Prescribing Trends: The preference has shifted toward Z-drugs and melatonin receptor agonists, driven by perceived safety profiles.

Regulatory and Market Barriers

Major barriers include:

• Safety Concerns: Dependency, withdrawal phenomena, cognitive impairment, and residual sedation have limited clinical acceptance.
• Regulatory Restrictions: Strict controls and scheduling impede broad commercialization.
• Market Competitiveness: Alternative agents with better safety profiles dominate.

Opportunities and Challenges

While the overall market is shrinking, niche opportunities exist:

• Reformulation and Novel Delivery: Developing formulations that mitigate dependence could spark renewed interest.
• Use in Developing Countries: Regulatory laxity may permit continued use; however, sustainability is questionable amid global safety trends.

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Market Projection and Future Outlook

Short-term (1-3 Years)

• Clinical activity around Flurazepam Hydrochloride will likely stagnate, with minimal new trials due to safety concerns and regulatory hurdles.
• Market sales are expected to decline further as practitioners pivot to safer alternatives.
• Limited manufacturing will persist in regions with less restrictive drug policies, but volumes will remain low.

Medium to Long-term (3-10 Years)

• Discontinuation Likelihood: Most pharmaceutical companies will cease production owing to liability and declining demand.
• Regulatory Tightening: Increasing global emphasis on medication safety will reduce permissible indications, especially in developed markets.
• Potential Resurgence: Innovations in formulation or reclassification might temporarily restore interest, but only if safety issues are substantially addressed.

Emerging Strategies

• Reformulation efforts aiming to produce ultra-short acting or non-addictive derivatives could potentially re-establish clinical relevance.
• Pharmacovigilance reports will continue to monitor adverse effects, limiting widespread use.

Conclusion

The future of Flurazepam Hydrochloride appears constrained by safety issues, regulatory restrictions, and evolving treatment paradigms. Its market will remain niche, primarily in regions with less stringent controls, unless significant innovations mitigate its risks.

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Key Takeaways

• Clinical trials for Flurazepam Hydrochloride are largely inactive, focused mainly on safety assessments, indicating declining research interest due to safety concerns.
• Market dynamics have shifted dramatically, with the drug's former prominence diminishing due to the dominance of newer, safer sleep agents.
• Regulatory frameworks continue to restrict manufacturing and prescribing, limiting growth prospects.
• Future prospects hinge on innovative formulations that address dependency and safety issues; otherwise, the drug’s role will diminish further.
• Investment opportunities in the sleep disorder market are better focused on novel agents with improved safety profiles rather than traditional benzodiazepines like flurazepam.

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FAQs

1. Why has the clinical research on Flurazepam Hydrochloride declined?
Research has waned primarily due to concerns over dependency, cognitive impairment, and safety profiles, making it less favorable compared to newer sleep agents with better safety margins.

2. Is Flurazepam Hydrochloride still approved for use worldwide?
Its approval varies globally. Major regulators like the FDA restrict its use due to safety risks, though certain regions may still permit limited prescribing.

3. What are the main safety concerns associated with Flurazepam Hydrochloride?
Dependence, withdrawal symptoms, residual sedation, cognitive impairment, and increased risk of falls in elderly patients are notable concerns.

4. Could reformulation or new delivery systems revive its market?
Potentially, if formulations can significantly mitigate dependence and adverse effects. However, regulatory approval would be challenging.

5. Which alternatives are replacing Flurazepam Hydrochloride in insomnia treatment?
Z-drugs (zolpidem, zopiclone), melatonin receptor agonists (ramelteon), and behavioral therapies are now preferred due to better safety profiles.

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References

1. [1] U.S. Food and Drug Administration. Drug Schedule and Regulations. 2023.
2. [2] ClinicalTrials.gov. Search Results for Flurazepam. 2023.
3. [3] European Sleep Research Society. Comparative Study on Benzodiazepines and Sleep Outcomes. 2020.
4. [4] Market Research Future. Insomnia Drugs MarketAnalysis. 2022.
5. [5] World Health Organization. Guidelines on Benzodiazepine Use. 2019.

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This report synthesizes the current state, regulatory environment, and future opportunities for Flurazepam Hydrochloride, providing stakeholders with a clear insight into its evolving place in sleep medicine.