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NCT00330291 ↗	Xyrem for Treatment Refractory Insomnia Due to PTSD	Withdrawn	State University of New York - Upstate Medical University	Phase 2	2005-08-01	Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep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.

Clinical Trial Conditions for TEMAZEPAM

Condition Name

Condition Name for TEMAZEPAM
Intervention	Trials
Insomnia	3
Anxiety, Post Traumatic	1
Pain, Postoperative	1
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for TEMAZEPAM
Intervention	Trials
Sleep Initiation and Maintenance Disorders	4
Schizophrenia	1
Pulmonary Disease, Chronic Obstructive	1
Heart Valve Diseases	1

Clinical Trial Locations for TEMAZEPAM

Trials by Country

Trials by Country for TEMAZEPAM
Location	Trials
United States	2
Germany	1
Netherlands	1
Nepal	1
Finland	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
Not yet recruiting	1
Withdrawn	1

Clinical Trial Sponsors for TEMAZEPAM

Sponsor Name

Sponsor Name for TEMAZEPAM
Sponsor	Trials
Duke University	2
Saint-Joseph University	1
Turku University Hospital	1

Sponsor Type

Sponsor Type for TEMAZEPAM
Sponsor	Trials
Other	10
Industry	1

Last updated: July 25, 2026

Temazepam clinical trials update, market analysis, and exclusivity timeline for FDA-listed sedative

Temazepam (benzodiazepine; oral capsule/tablet) is an established, off-patent small molecule in most major markets. Near-term value is driven by ongoing demand from insomnia and anxiety indications, supply stability, and payer/channel dynamics rather than late-stage clinical innovation. Public clinical-trial activity is limited relative to newer insomnia agents, and regulatory risk concentrates on generic quality, manufacturing capacity, and any label maintenance changes.

Are there active clinical trials for temazepam, and what are they testing?

Temazepam has historically been studied in insomnia and related sleep-disorder settings, typically via trials that compare hypnotic efficacy, onset/maintenance of sleep, and tolerability against placebo and other sedatives. Current publicly visible trial pipelines tend to be small, investigator-led, or focused on formulation bioequivalence or real-world label/usage assessments, rather than new mechanism-of-action development.

What trial types dominate temazepam studies

• Bioequivalence (BE) and pharmacokinetic (PK) studies for generic manufacturers.
• Sleep-medicine comparators (benzodiazepines, benzodiazepine receptor agonists) in insomnia cohorts.
• Tolerability and safety monitoring studies focusing on sedation, next-day impairment, falls risk, and dependence/withdrawal.

Where trial activity typically clusters

• US-based BE/PK and bridging studies for NDA-to-ANDA product updates.
• EU/UK BE studies aligned to EMA/MHRA bioequivalence expectations for generics and line extensions.

Practical read-through for investors and BD

• A “clinical trials update” for temazepam usually maps to generic product lifecycle events (formulation and manufacturing changes) rather than meaningful differentiation.
• Any “new” signal in registries is likely tied to supply continuity and product replication under abbreviated pathways.

What is the current FDA regulatory status of temazepam, and what does it imply for launches?

Temazepam is marketed as an established benzodiazepine hypnotic. In the US, the main regulatory structure is the ANDA ecosystem (generic temazepam products), with labeling largely anchored to the original NDA framework.

What to expect in Orange Book status

• Large number of listed generic ANDAs, with variable patent coverage in the Orange Book that often matures quickly for established benzodiazepines.
• For business planning, the decisive factor is not “existence of patents” but whether any listed exclusivities, unexpired patents tied to specific dosage forms, or pediatric exclusivity remain for specific strengths/formulations.

What the regulatory pathway means for competitive entry

• For an already established molecule, FDA entry risk is usually less about clinical differentiation and more about:
  • Patent/Orange Book clearance for the specific listed product(s)
  • Chemistry and controls for BE acceptance
  • Supply chain scale and inspection readiness

What patents protect temazepam, and when do they expire?

Temazepam is an old benzodiazepine. In most jurisdictions it is not expected to have meaningful composition-of-matter protection left. The practical patent estate is commonly limited to:

• Process improvements
• Specific formulations or dosage forms
• Method-of-use label-related patents, depending on historical filings and assignments

How exclusivity timelines typically look for established benzodiazepines

• Primary exclusivities (if any) are long expired.
• Market entry barriers are more often regulatory and quality-based than legal, unless a residual formulation patent or unexpired listed patent remains for a niche product configuration.

What matters for “generic entry risks” in temazepam

• Whether any Orange Book patents remain for a particular strength (for example, capsule vs tablet) and whether the listing is being challenged.
• Whether any recent litigation settlements or consent decrees constrain launch timing for specific ANDA filers.

How strong is the patent estate for temazepam, and where is litigation most likely?

For an established benzodiazepine like temazepam, patent strength generally trends low compared with modern brand portfolios. Litigation, when it occurs, is usually tied to:

• Orange Book listed patents for generic entry
• Disputes over manufacturing changes, label parity, or product-specific infringement theories

Likely litigation posture

• Many matters resolve through settlements allowing timely generic launches.
• If litigation occurs, it tends to be concentrated around specific dosage forms or line extensions.

Business implication

• Competitive strategy should treat temazepam primarily as a supply, compliance, and channel execution product, with legal work scoped to product-specific Orange Book listings rather than molecule-level coverage.

What formulations are sold for temazepam, and which ones drive demand?

Temazepam is marketed primarily as oral dosage forms. Commercial preference is typically shaped by:

• Payer formulary placement
• Availability (brand vs multiple generics)
• Dosing flexibility and patient tolerance
• Safety labeling emphasizing next-day sedation risk

Typical dosage forms influencing market share

• Capsules (strength-dependent)
• Tablets (strength-dependent)

How dosage form affects IP and manufacturing risk

• Even for an off-patent molecule, manufacturing and BE acceptance are product-specific.
• Quality failures, recalls, and capacity constraints can shift demand quickly among available competitors.

Which companies compete in temazepam, and how does the market structure look?

Temazepam’s market structure is usually characterized by:

• Multiple generic manufacturers with fragmented share
• Brand erosion after generic entry
• Concentration risk if fewer suppliers can meet demand

Competitive landscape pattern for established benzodiazepines

• National wholesalers and pharmacy chains typically carry multiple ANDA suppliers.
• When shortages occur, distribution allocations can temporarily concentrate sales with fewer qualified manufacturers.

What is the temazepam market forecast, and what drives revenue projection?

A realistic revenue projection for temazepam is usually driven by:

• Chronic and repeat prescriptions for insomnia treatment patterns
• Formulary and reimbursement dynamics
• Supply continuity and generic pricing
• Regulatory and enforcement actions affecting product availability

Market forecast framework for projection models

• Units: prescription counts and average prescription size by strength and dosage form.
• Pricing: generic net price trends, including periodic dips from new entrants.
• Share shifts: recalls and manufacturing downtime changing effective market supply.

Key demand variables

• Patient and prescriber preferences for other insomnia therapies (including non-benzodiazepines and behavioral sleep interventions).
• Safety communications influencing prescribing practices for benzodiazepines.
• Shifts between benzodiazepines and alternative sedatives under payer controls.

Projection direction (base-case)

• Revenue growth is usually modest in developed markets because temazepam is off-patent with competitive generic pricing.
• Upside comes from supply normalization after disruptions and from formulary stability that keeps temazepam accessible.

How do temazepam sales compare with other insomnia sedatives (benzodiazepines vs Z-drugs)?

Temazepam competes in the broader insomnia hypnotic class that includes:

• Benzodiazepines (class competitors)
• Non-benzodiazepine hypnotics (Z-drugs)
• Other hypnotic categories (depending on jurisdiction and payer mix)

Where temazepam typically sits commercially

• Often positioned as a lower-cost, widely available benzodiazepine option.
• Loses share when prescribers and payers favor non-benzodiazepine or newer branded options, but retains volume due to cost and clinician familiarity.

What generic entry risks exist for temazepam?

For temazepam, “generic entry risk” is less about scientific viability and more about:

• Regulatory clearance specific to listed patents or exclusivities tied to dosage form/strength
• Manufacturing and inspection outcomes
• BE study acceptance and ongoing stability/scale-up

Key risk events to model

• Orange Book listings that could still be asserted for a specific product configuration
• Consent decrees or settlement-driven delays affecting particular ANDA filers
• Recalls and supply shortages that can both help incumbents and create short-term demand volatility

What would a licensing strategy for temazepam focus on?

Licensing and BD for temazepam typically targets:

• Product portfolio expansion by strength/dosage form
• Manufacturing rights and transfer of approved capabilities
• Contract manufacturing capacity to reduce supply risk in public drug shortages

Where licensing value is most likely created

• Where a company can reliably manufacture and supply multiple strengths with inspection-ready controls.
• Where payer contracts favor robust availability, reducing lost sales from stockouts.

Key Takeaways

• Temazepam’s clinical “updates” are usually dominated by BE/PK and lifecycle studies rather than new therapeutic development.
• Market value is driven primarily by generic supply, pricing competition, and formulary access.
• Patent and exclusivity leverage is typically limited for the molecule, so product-specific Orange Book listings and any residual formulation or method patents matter more than molecule-level ownership.
• Forecasting should treat temazepam as a supply-and-channel product with modest growth potential and elevated volatility around availability.

FAQs

1) Does temazepam have ongoing new drug development for insomnia?
Publicly visible activity is typically limited to formulation/PK and generic lifecycle work rather than novel mechanism trials.

2) Why can temazepam face shortages even after generic entry?
Manufacturing capacity constraints, inspection outcomes, and quality recalls can reduce the number of reliable suppliers, concentrating supply and shifting availability.

3) How do strength and dosage form affect temazepam competition?
BE and manufacturing are product-specific, so even within the same molecule, competition and availability can differ by strength and capsule vs tablet.

4) What are the main compliance risks for temazepam manufacturers?
Controlled substance handling requirements, withdrawal/dependence-related labeling parity, and quality systems to prevent recalls and batch failures.

5) What inputs should be used for a temazepam market projection model?
Prescription units by strength, generic net price trajectory, formulary placement trends, and supply interruptions by competitor.

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References

No sources were provided in the prompt and no citations can be generated without verifiable registry, Orange Book, or trial-identifying documentation.