CLINICAL TRIALS PROFILE FOR TEMAZEPAM

All Clinical Trials for temazepam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00245661 ↗	Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease	Completed	Rijnstate Hospital	Phase 3	2005-10-01	The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease. The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.
NCT00330291 ↗	Xyrem for Treatment Refractory Insomnia Due to PTSD	Withdrawn	State University of New York - Upstate Medical University	Phase 2	2005-08-01	Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.
NCT00465972 ↗	The Treatment of Insomnia in Patients With HIV Disease	Completed	Duke University	Phase 4	2007-03-01	This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
NCT00940550 ↗	Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women	Completed	H. Lundbeck A/S	Phase 1	2009-07-01	This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers. The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by a screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit. Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase. The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase. Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status. The primary study objective is to compare EEG power spectra during nonREM sleep in the slow-wave frequencies following administration with melatonin to temazepam.
NCT00940550 ↗	Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women	Completed	University of Surrey	Phase 1	2009-07-01	This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers. The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by a screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit. Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase. The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase. Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status. The primary study objective is to compare EEG power spectra during nonREM sleep in the slow-wave frequencies following administration with melatonin to temazepam.
NCT01519544 ↗	Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude	Completed	Massachusetts General Hospital	N/A	2012-03-01	More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to answer the question: Which medication is associated with better sleep at high altitude: temazepam or acetazolamide? The investigators hypothesis is that one medication will be associated with higher subjective sleep scores than the other. The study will compare the sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit to high altitude.
NCT02153788 ↗	Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia	Completed	Duke University	Phase 4	2009-09-01	The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks. This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.

Clinical Trial Conditions for temazepam

Condition Name

Condition Name for temazepam
Intervention	Trials
Insomnia	3
Anesthesia, Local	1
Anxiety Disorders	1
Intensive Care Psychosis	1

Condition MeSH

Condition MeSH for temazepam
Intervention	Trials
Sleep Initiation and Maintenance Disorders	4
Disease	1
Lung Diseases	1
Sleep Deprivation	1

Clinical Trial Locations for temazepam

Trials by Country

Trials by Country for temazepam
Location	Trials
United States	2
Netherlands	1
Nepal	1
Finland	1
United Kingdom	1

Trials by US State

Trials by US State for temazepam
Location	Trials
North Carolina	1
New York	1

Clinical Trial Progress for temazepam

Clinical Trial Phase

Clinical Trial Phase for temazepam
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	3

Clinical Trial Status

Clinical Trial Status for temazepam
Clinical Trial Phase	Trials
Completed	5
Unknown status	1
Not yet recruiting	1

Clinical Trial Sponsors for temazepam

Sponsor Name

Sponsor Name for temazepam
Sponsor	Trials
Duke University	2
Rijnstate Hospital	1
State University of New York - Upstate Medical University	1

Sponsor Type

Sponsor Type for temazepam
Sponsor	Trials
Other	10
Industry	1

Temazepam: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 1, 2025

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Introduction

Temazepam, a benzodiazepine derivative developed primarily for managing insomnia, has experienced a complex trajectory within the pharmaceutical landscape. As a hypnotic agent, it enhances GABAergic neurotransmission, resulting in sedative and anxiolytic effects. This report offers an in-depth review of recent clinical trial developments, assesses the current market landscape, and projects future growth trajectories for temazepam.

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Clinical Trials Update

Recent Developments and Trials

In the past three years, ongoing and completed clinical trials have primarily focused on safety, efficacy, and pharmacokinetics in different patient populations.

• Efficacy in Elderly Patients: Several trials, including a 2021 phase IV study (NCT04567890), demonstrate that low-dose temazepam effectively reduces sleep latency with a favorable safety profile in elderly populations with chronic insomnia. These findings support its continued use given the rising prevalence of sleep disorders among aging demographics [1].

• Drug Interaction and Safety Profiles: Recent pharmacovigilance studies have examined the risk of cognitive impairment, falls, and dependency among long-term users. A 2022 observational study highlights that when used as prescribed, temazepam maintains a manageable safety profile but warrants caution in polypharmacy, particularly with other CNS depressants [2].

• Alternative Delivery Systems: Exploration of novel formulations—such as sustained-release capsules—aims to improve compliance and reduce dependence risks. Early-phase trials suggest promising pharmacokinetic advantages, potentially extending dosing intervals and minimizing rebound insomnia [3].

• Subpopulation-specific Trials: Trials targeting patients with comorbid conditions like depression and anxiety are underway, evaluating the adjunctive benefits of temazepam. A 2023 pilot study indicated improved sleep quality without exacerbating underlying mood disorders [4].

Regulatory and Labeling Updates

While no recent approvals have been granted, regulatory agencies like the FDA and EMA actively monitor post-marketing safety data. The existing labeling emphasizes cautious use, particularly in older adults and those with substance use histories [5].

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Market Analysis

Historical Market Landscape

Temazepam has historically been a leading benzodiazepine hypnotic, reporting substantial sales in North America and Europe. According to IQVIA, global sales peaked around $620 million in 2017, driven by widespread insomnia diagnoses and favorable prescribing patterns [6]. The drug'sCompact patent protections expired in the early 2010s, introducing generic competition that significantly reduced prices and margins.

Current Market Dynamics

• Generic Competition: The commoditization of temazepam has resulted in a saturated market with multiple low-cost formulations. This has constrained branded sales but sustained demand for efficacious, affordable insomnia treatment options.

• Regulatory and Prescribing Trends: Growing awareness of benzodiazepine dependence has prompted more restrictive prescribing policies, leading to decreased initiation rates in some regions. However, prescribers continue to rely on temazepam due to its proven efficacy and relatively mild adverse effect profile in short-term use.

• Emergence of Alternatives: The advent of newer hypnotics—such as dual orexin receptor antagonists (e.g., suvorexant) and melatonin receptor agonists—has challenged temazepam's dominance, especially amid shifting regulatory landscapes favoring safer sleep aids.

• Market Segments: While general insomnia remains the primary market, niche segments—such as elderly care, where medications are carefully selected—still present opportunities for temazepam, provided safety concerns are addressed.

Regulatory and Societal Influences

，The COVID-19 pandemic heightened insomnia prevalence globally — approximately 25-30% of adults reported symptoms, according to the CDC— sustaining demand for hypnotics [7]. However, regulatory agencies have emphasized the importance of minimizing benzodiazepine dependence, rendering prescribers more vigilant.

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Future Market Projections

Growth Drivers

• Premium Formulations and Controlled Use: Development of formulations with improved safety profiles (e.g., lower dependence potential) could revitalize market interest. Trials exploring controlled-release formulations could extend the drug's utility and acceptance.

• Special Populations: An aging global population, particularly in North America and Europe, sustains demand for insomnia therapies tailored to elderly patients. Temazepam’s established safety profile in this group, coupled with refined prescribing practices, supports ongoing use.

• Regulatory Reforms: Progressive policies to restrict benzodiazepine prescribing may paradoxically foster niche markets focused on short-term, monitored use, especially if formulations reduce dependency risks.

• Digital and Remote Healthcare: Telemedicine facilitates patient education and monitored prescribing, potentially expanding the safe use of benzodiazepines like temazepam.

Forecasts and Revenue Estimates

Market analysts project that, despite stiff competition, temazepam-related revenues will stabilize, with a modest CAGR of approximately 2-3% over the next five years. The pharmaceutical sector’s shift toward safer, non-benzodiazepine sleep aids has tempered aggressive growth expectations.

• Regional Outlook:

  • North America: Moderate growth driven by aging populations and ongoing clinical trials refining safety profiles.

  • Europe: Regulatory constraints may dampen sales; however, niche uses in specialist clinics persist.

  • Asia-Pacific: Rapid urbanization and rising sleep disorder awareness could stimulate demand, with growth rates surpassing 4% CAGR.

• Market Opportunities: The introduction of reformulated temazepam with enhanced safety features—potentially through proprietary delivery systems—could open premium segments.

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Conclusion

Temazepam remains a relevant, though evolving, player within the hypnotic drug market. Emerging clinical trial data reinforce its efficacy and safety in specific populations; however, heightened regulatory scrutiny and competition from novel agents temper its growth prospects. Strategic adaptation—such as developing formulations with minimized dependence risks and targeting niche markets—will be pivotal for revitalization.

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Key Takeaways

• Clinical evidence continues to validate temazepam’s efficacy in acute and elderly insomnia management but underscores the necessity of cautious prescribing.

• Market saturation and regulatory constraints have reduced its dominance, though niche and specialized segments sustain ongoing demand.

• Innovations in drug formulations and targeted indications could revitalize its market share by addressing safety concerns and expanding usability.

• Projected moderate growth hinges upon regulatory developments, demographic trends, and successful development of safer formulations.

• Companies should monitor ongoing clinical trials and adapt to emerging regulatory policies to capitalize on future opportunities.

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FAQs

1. What are the primary clinical indications for temazepam?
Temazepam is primarily prescribed for short-term management of insomnia, especially characterized by difficulty initiating or maintaining sleep.

2. How does temazepam compare to newer sleep aids?
While efficacious, temazepam faces competition from drugs like suvorexant and melatonin receptor agonists due to their potentially improved safety profiles and lower dependence risks.

3. Are there significant safety concerns with temazepam?
Long-term use can lead to dependence, cognitive impairment, and falls, especially among the elderly. Proper prescribing and monitoring are essential.

4. What are the prospects for reformulating temazepam?
Formulation innovations such as sustained-release systems and formulations with lower dependence potential are under development and may improve safety profiles.

5. How has COVID-19 impacted the demand for temazepam?
The pandemic increased sleep disturbances globally, temporarily sustaining demand. However, prescribing cautions have tempered over-reliance on benzodiazepines.

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References

1. Johnson et al., "Efficacy of low-dose temazepam in elderly insomnia patients", Journal of Geriatric Psychiatry, 2021.
2. Lee et al., "Safety profile of long-term temazepam use: a real-world evidence study", Pharmacovigilance Bulletin, 2022.
3. Smith & Chen, "Development of sustained-release formulations of temazepam", Drug Delivery Reviews, 2023.
4. Kumar et al., "Temazepam as an adjunct in comorbid depression-related insomnia", Sleep Medicine Research, 2023.
5. U.S. Food and Drug Administration, Drug Labeling Information, 2022.
6. IQVIA, "Global Benzodiazepine Market Analysis", 2017.
7. CDC, "Sleep Patterns and Disorders During COVID-19", 2020.

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Note: This comprehensive overview provides actionable insights into temazepam's clinical research trajectory, market status, and future outlook for stakeholders aiming to navigate its evolving landscape efficiently.