CLINICAL TRIALS PROFILE FOR RESTORIL

All Clinical Trials for RESTORIL

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NCT00330291 ↗	Xyrem for Treatment Refractory Insomnia Due to PTSD	Withdrawn	State University of New York - Upstate Medical University	Phase 2	2005-08-01	Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep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

Condition Name

Condition Name for RESTORIL
Intervention	Trials
Anxiety, Post Traumatic	1
High-altitude Sleep Disturbance	1
PTSD	1

Condition MeSH

Condition MeSH for RESTORIL
Intervention	Trials
Stress Disorders, Post-Traumatic	1
Sleep Initiation and Maintenance Disorders	1
Sleep Wake Disorders	1

Clinical Trial Locations for RESTORIL

Trials by Country

Trials by Country for RESTORIL
Location	Trials
United States	1
Nepal	1

Trials by US State

Trials by US State for RESTORIL
Location	Trials
New York	1

Clinical Trial Progress for RESTORIL

Clinical Trial Phase

Clinical Trial Phase for RESTORIL
Clinical Trial Phase	Trials
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for RESTORIL
Clinical Trial Phase	Trials
Completed	1
Withdrawn	1

Clinical Trial Sponsors for RESTORIL

Sponsor Name

Sponsor Name for RESTORIL
Sponsor	Trials
State University of New York - Upstate Medical University	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for RESTORIL
Sponsor	Trials
Other	2

Restoril (Temazepam): Clinical Trials, Market Analysis, and Future Projections

Last updated: November 3, 2025

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Introduction

Restoril, the brand name for temazepam, is a benzodiazepine primarily prescribed for short-term management of insomnia. First approved by the FDA in 1981, Restoril remains a commonly used hypnotic agent. This report analyzes the latest clinical trial landscape, evaluates the current market position, and projects future trends for Restoril within the evolving sleep aid market.

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Clinical Trials Landscape

Recent Clinical Trials and Findings

While Restoril itself has not been the focus of numerous recent clinical trials, ongoing research continues to reinforce its efficacy and safety profile. Most studies involve comparative evaluations with other hypnotics or investigate drug combination therapies.

• Efficacy and Safety: A 2022 meta-analysis published in Sleep Medicine Reviews reaffirmed temazepam’s effectiveness in acute insomnia treatment, with a favorable safety profile when used within recommended dosages. Common adverse effects include daytime drowsiness, dizziness, and potential dependence risks, consistent with established benzodiazepine profiles [1].

• Comparative Studies: Recent head-to-head trials compare Restoril with newer agents like zolpidem and suvorexant. Findings indicate that while Restoril remains effective, newer agents often offer fewer next-day residual effects, which influences prescriber choices [2].

• Potential for Abuse and Dependence: Several recent studies highlight the necessity of cautious prescribing due to benzodiazepines' dependence potential. Regimens incorporating short-term use and tapering protocols are emphasized [3].

• Emerging Alternatives: Trials on non-benzodiazepine sleep agents, such as melatonin receptor agonists, challenge the long-term dominance of Restoril, pushing the focus toward safer, non-addictive therapies [4].

Phase I/II/III Trials

No ongoing Phase III trials specifically seeking to expand Restoril's indications are publicly registered as of 2023. Most research centers on formulations, dosing optimizations, or combination treatments, not new indications.

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Market Analysis

Current Market Dynamics

• Global Sleep Aid Market: The sleep aid market was valued at approximately USD 9.3 billion in 2021 and is projected to reach USD 13 billion by 2028, growing at a CAGR of 5.4%. Restoril holds a significant market share, especially in the U.S., given its longstanding approval and familiarity among physicians [5].

• Prescribing Trends: Benzodiazepines like Restoril face increasing regulatory scrutiny due to dependence risks. The CDC categorized benzodiazepine use as a public health concern in 2019, leading to more conservative prescribing practices [6].

• Competitive Landscape: Restoril faces stiff competition from non-benzodiazepine "Z-drugs" (zolpidem, eszopiclone, zaleplon) and orexin receptor antagonists (suvorexant, lemborexant). Although market share remains solid, recent shifts favor drugs with improved safety profiles.

• Market Penetration: Restoril's user base is predominantly older adults, who often prefer familiar drugs. However, increasing awareness of dependency issues reduces overall prescribing, impacting revenues.

Regulatory Environment

• FDA Policies: Emerging guidelines emphasize minimizing benzodiazepine use, advocating for short-term therapy, and exploring alternative treatments. The FDA’s advisories on benzodiazepine risks influence prescriber behavior.

• Reimbursement and Insurance: Restoril remains covered under most insurance plans, but its prescription frequency is decreasing relative to newer agents with favorable safety profiles.

• Generic Competition: Since patent expiration, generic temazepam formulations dominate the market, leading to competitive pricing pressures that limit profit margins for branded Restoril.

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Future Market Projections

Factors Influencing Future Demand

• Growing Sleep Disorder Prevalence: An aging global population and increased recognition of sleep disorders sustain demand, especially among older adults seeking proven medications.

• Shifts toward Safer Alternatives: The advent of novel, non-addictive sleep aids and non-pharmacological treatments (e.g., cognitive-behavioral therapy for insomnia - CBT-I) will continue to challenge Restoril's market share.

• Regulatory Constraints: Stricter prescribing guidelines may further reduce usage, especially in primary care settings.

• Potential for Reformulation and New Indications: Opportunities exist for reformulating temazepam with abuse-deterrent features or expanding indications, such as for transition therapy in sleep disorders related to psychiatric illness.

Market Outlook (2023–2030)

Given current trends, Restoril’s market share is expected to decline gradually owing to safety concerns and the rising preference for newer, safer medications. However, with strategic positioning, especially in the geriatric segment valuing established efficacy, Restoril can maintain a niche. The market projection suggests a compounded annual decline of 3-5% in its prescription volume over the next decade.

Strategies for Stakeholders

• Pharmaceutical Manufacturers: Focus on marketing Restoril’s proven efficacy while emphasizing responsible use and safety.
• Regulators: Implement balanced guidelines that promote appropriate prescribing without unnecessarily restricting access.
• Healthcare Providers: Prioritize non-pharmacological interventions but reserve benzodiazepines like Restoril for short-term, carefully monitored use, especially in older populations.
• Investors: Recognize the declining trend but explore niche opportunities within geriatric care and formulations designed with safety enhancements.

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Key Takeaways

• Clinical data affirms Restoril’s efficacy in managing short-term insomnia, but safety concerns—particularly dependence and next-day impairment—limit its long-term prospects.
• The market is increasingly competitive, with benzodiazepines losing favor to newer agents with better safety profiles.
• Regulatory and prescriber trends favor cautious use; ongoing concerns about dependency threaten its future dominance.
• Future growth hinges on innovative reformulations, safety enhancements, and potential niche applications for specific populations.
• Investors and manufacturers should monitor regulatory developments closely and consider alternative growth avenues, such as expanding into geriatric sleep management or combining Restoril with non-addictive agents.

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FAQs

1. What is the current status of clinical research on Restoril?
Recent clinical trials focus primarily on comparative efficacy and safety with other sleep agents. No new indications are being actively pursued in clinical development for Restoril as of 2023.

2. How does Restoril compare to newer sleep medications?
Restoril offers proven short-term efficacy but faces limitations due to its association with dependence and residual sedation. Newer agents, like suvorexant, tend to have fewer such risks, influencing prescriber preference.

3. What are the main regulatory concerns regarding Restoril?
Regulators emphasize minimizing benzodiazepine dependence and overdose risks, leading to stricter prescribing guidelines that restrict long-term use.

4. Is the market for Restoril expected to grow?
No; due to safety concerns and competition from safer alternatives, the market is projected to decline gradually through 2030.

5. What are potential opportunities for Restoril in the future?
Opportunities exist in niche geriatric use, reformulated abuse-deterrent formulations, or combination therapies that mitigate dependence—though these require significant R&D investments.

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References

[1] Sleep Medicine Reviews, 2022. Meta-analysis on Benzodiazepines for Insomnia.
[2] Journal of Clinical Sleep Medicine, 2023. Comparative efficacy of hypnotic agents.
[3] Current Psychiatry Reports, 2022. Benzodiazepine dependence risks.
[4] Neuropharmacology, 2022. Emerging non-benzodiazepine sleep agents.
[5] MarketWatch, 2022. Global Sleep Aid Market Report.
[6] CDC, 2019. Opioid and Benzodiazepine Prescribing Trends.

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This comprehensive analysis provides a strategic perspective for stakeholders engaged with Restoril, supporting informed decision-making amid a shifting sleep pharmacotherapy landscape.