An open-label, single-center, single-sequence study to evaluate the drug-drud interaction between the CYP3A substrate triazolam and TS-172 (part A) and the potent CYP3A inhibitor itraconazole and TS-172 (part B) in healthy male subjects on their pharmacokinetics, safety and tolerability

Start Date11 Mar 2025

Sponsor / Collaborator

Taisho Pharmaceutical Co., Ltd.

NCT03954483

/ RecruitingNot Applicable

Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

New technologies are needed to help diagnose anxiety disorders. EVestG has facilitated the identification of numerous possible biomarkers of several psychiatric disorders. Some EVestG features seem to be caused by differences in low-frequency modulation that is consistent (both in frequency and behaviour) with the hippocampal rhythm (theta), which is known to play a role in anxiety. Critically, there is ample support in the literature for an anatomical and functional basis for the modulation of vestibular signals via theta. If anxiety could be measured continuously, perhaps throughout a patient's day, or throughout a task, it might be able to confirm an anxiety disorder. However, current techniques for measuring theta are highly invasive, performed rarely, and only in epilepsy patients. EVestG technology, however, is non-invasive, and could potentially record anxiety levels in any subject for extended periods of time. The proposed study will attempt to identify hippocampal theta in vestibular signals in healthy participants through a double-blind administration of two different drugs that are dissimilar both pharmacologically and in acute clinical effects but which are known to reduce the theta rhythm.

Start Date16 Oct 2023

Sponsor / Collaborator

University of Manitoba

NCT03360123

/ CompletedNot ApplicableIIT

Oral Anxiolysis for the Older Pediatric Patient-Which Medication is Preferred?

This study will evaluate the perceptions of the effects of two anxiolytic medications commonly used during dental treatment in patients weighing 40 kilograms or more.

Start Date26 Jan 2018

Sponsor / Collaborator

University of Pittsburgh

100 Clinical Results associated with Triazolam

100 Translational Medicine associated with Triazolam

100 Patents (Medical) associated with Triazolam

2,490

Literatures (Medical) associated with Triazolam

01 Mar 2026·JOURNAL OF INORGANIC BIOCHEMISTRY

Impact of electrostatic distribution in CYP3A4 on the regioselectivity of triazolam metabolism and regulation of its metabolic rate by the iron spin states: Insights from MD simulations and QM calculations

Article

Author: Zheng, Qingchuan ; Ma, Xinyu ; Zhao, Yan

Triazolam (TRZ) is a representative benzodiazepine sedative-hypnotic drug that has gradually been abused due to the increasing societal pressures. To further provide a theoretical basis for the rationale use of TRZ and obtain more information for its metabolic process, in this study, human CYP3A4 was employed as the metabolic enzyme to investigate the metabolic mechanism of TRZ by multiple computational methods. Here, three types of substrate-binding conformations related to the diversity of TRZ metabolites are identified (pose A, pose B and pose C). The "sandwich" structure and the π-π stacking between TRZ and F304/porphyrin ring may be the key factors in dominating three substrate-binding conformations. Furthermore, we discovered pose A is the predominant binding mode, with Cα-H serving as the key metabolic site and CYP3A4-catalyzed Cα-H hydroxylation follows a hydrogen abstraction-rebound mechanism. More importantly, in hydroxylation process, the spin states of iron can regulate the metabolic reaction rate of TRZ and the highest rate of metabolism (5.96 s^-1) is found in the quartet spin states. Based on our findings, it can be suggested that rational incorporating aromatic groups into TRZ could improve its metabolic stability. Meanwhile, the transition of the heme iron from a low-spin to a high-spin state appears to accelerate TRZ metabolism, potentially leading to the accumulation of α-OH triazolam in vivo, which may pose risks to human health. These results could enhance our understanding of CYP3A4-mediated regioselective metabolism of TRZ and provide a theoretical foundation and new perspective for studies on the metabolism of other triazole drugs.

01 Jan 2026·Forensic Toxicology

Hair testing for investigating intake and use history of hypnotics in the forensic field

Review

Author: Sato, Takako ; Shima, Noriaki ; Katagi, Munehiro

Abstract:

Purpose:

Hair testing for drugs has been used extensively in the forensic field since the 1990s, primarily in cases involving abused drugs such as methamphetamine and cocaine. Since the 2010s, its scope has expanded to include the detection of single dose of hypnotics, aiding in the investigation of serious crimes. This review presents essential knowledge for hair testing and the currently recommended analytical procedures and forensic applications.

Methods:

A review of literature from the 1990s to the 2020s was conducted, focusing on analytical methods for detecting drugs in hair, drug concentrations in hair, and drug incorporation pathways.

Results:

The characteristics of hair as a biological specimen include a longer detection window than other matrices such as urine and blood, as ingested drugs remain stable in hair over time. Significant differences in drug concentrations in hair are observed among substances, with several hypnotics, such as triazolam, having extremely low concentrations. Drugs are incorporated into hair primarily through two main pathways (the hair bulb and the upper dermis zone), with the dominant pathway depending on the drug’s properties. In addition, hair dyeing and subsequent exposure to aqueous environments (e.g., daily hair washing) can significantly influence drug concentrations and their distribution patterns (concentration and hair region). These factors must be carefully considered in hair testing.

Conclusions:

Hair testing is an effective means for proving drug intake and estimating use history, particularly in cases where there is a delay in reporting the incident. The interpretation of results must account for various factors, such as the chemical structures of drugs, incorporation pathways, and hair dyeing.

03 Oct 2025·MEDICINE

What does data on adverse reactions reveal about benzodiazepines and suicide-related risk?: A disproportionality analysis using FDA FAERS pharmacovigilance data

Article

Author: Zhang, Chenyu ; Yang, Ren ; Guo, Weiling ; Yan, Liang

Benzodiazepines (BZDs) are widely used in the treatment of psychiatric disorders, but their association with suicidal/self-injurious behavior is conflicting. This study investigated the relationship between BZDs and suicidal and self-injurious behavior, by analyzing data from the FDA Adverse Event Reporting System. We analyzed FDA Adverse Event Reporting System data from January 2004 and March 2025, to analyze adverse events (AEs) associated with suicidal and self-injurious behavior in BZDs. Thirty-eight BZDs were initially identified via the WHO Anatomical Therapeutic Chemical Code System. After excluding 26 BZDs with insufficient psychiatric disorder-related AEs (<50 reports), 12 (diazepam, chlordiazepoxide, oxazepam, potassium clorazepate, lorazepam, bromazepam, clobazam, alprazolam, flurazepam, triazolam, temazepam, and midazolam) were retained for disproportionality analysis using zolpidem as a control. Reporting odds ratios (RORs) were calculated, and subgroup analysis assessed risk variations by age and gender. Among 52,767 psychiatric disorders AEs, 9474 (17.95%) involved suicidal and self-injurious behaviors. Compared to zolpidem, diazepam (ROR = 1.38), chlordiazepoxide (ROR = 1.62), oxazepam (ROR = 2.14), lorazepam (ROR = 1.11), alprazolam (ROR = 1.64), flurazepam (ROR = 3.26) triazolam (ROR = 1.68), and temazepam (ROR = 1.72) showed significantly elevated risks, while clobazam (ROR = 0.46) and midazolam (ROR = 0.37) demonstrated protective effects. Subgroup analyses revealed higher risks in females using diazepam, oxazepam, lorazepam, alprazolam and temazepam. Adults <65 years who used potassium clorazepate, lorazepam, clobazam, alprazolam, or triazolam faced a significantly higher suicide-related risk than those ≥65 years. Compared to zolpidem, BZDs demonstrate varied suicide-related risks, which necessitated personalized risk-benefit evaluations and increased monitoring for high-risk agents such as flurazepam and alprazolam.

News (Medical) associated with Triazolam

02 Mar 2026

·www.drugs.com

Benzodiazepine Use Down In U.S., But OD Risk Remains, Study Says

MONDAY, March 2, 2026 — Benzodiazepine prescriptions have decreased in the United States, mainly among middle-aged adults and seniors, a new study says. But these drugs still pose a risk to many people, according to findings published recently in the Journal of Clinical Psychiatry . Nearly half of patients still prescribed benzodiazepines also are taking other drugs that might cause harmful interactions, increasing the risk of a fatal overdose, researchers found. “Although benzodiazepine use is declining in U.S. outpatient care, the high rate of co-prescribing with other central nervous system depressants underscores the need for careful monitoring,” lead researcher Dr. Mark Olfson said in a news release. He’s a professor of epidemiology at the Columbia University Mailman School of Public Health in New York City. Benzodiazepines work by activating a brain chemical that makes the nervous system less sensitive to stimulation, according to Drugs.com . They are used to treat conditions like anxiety, seizures, sleep disorders and alcoholism. Common benzodiazepines include Xanax (alprazolam), Valium (diazepam), Halcion (triazolam) and Klonopin (clonazepam). However, benzodiazepines can contribute to an overdose if they’re used with opioids, researchers said in background notes. Between 2000 to 2019, benzodiazepine-related OD deaths leapt sixfold, rising from just under 0.5 deaths per 100,000 adults to nearly 3 per 100,000, researchers noted. “Considerable controversy has surrounded the appropriate role of benzodiazepines in clinical practice because of their withdrawal symptoms and risks, including falls, motor vehicle crashes, cognitive impairment and overdose,” Olfson said. For the new study, researchers analyzed data from more than 104,000 U.S. adults who participated in a federal health survey between 2018 to 2022. As part of the survey, participants were asked about their use of benzodiazepines and other medications. Overall, benzodiazepine use among adults dropped from 4.7% in 2018 to 3.4% in 2022, the data showed. The decrease was steeper among those 56 and older — from 7.2% to 4.7% — compared to younger adults 36 to 55 (from 4.4% to 3.4%) and those 18 to 35 (2.1% to 1.8%). Researchers also found that nearly 42% of people using benzodiazepines also took another drug during the same year that can depress the central nervous system, increasing overdose risk. Such co-prescribing was more common among adults 36 to 55 (45%) and those 56 or older (43%) than among younger adults 18 to 35 (30%). More concerningly, many of those with potentially dangerous benzodiazepine co-prescriptions were in shaky health. About 72% of people in fair to poor health were prescribed a drug that could dangerously interact with benzodiazepines, as were 63% of people with serious psychological distress, researchers found. “Before initiating a benzodiazepine, clinicians should review a patient’s full medication list to assess potential drug to drug interactions — particularly for patients in poor health or experiencing serious psychological distress,” Olfson said. Sources Columbia University, news release, Feb. 25, 2026 Journal of Clinical Psychiatry, Feb. 18, 2026

Clinical Result

02 Jul 2024

·www.drugs.com

Use of 'Benzo' Sedatives Like Valium, Xanax Won't Raise Dementia Risk: Study

TUESDAY, July 2, 2024 -- Benzodiazepines do not appear to increase dementia risk, but could have subtle long-term effects on brain structure, a new study reports. Researchers found no link between use of the sedative drug and a higher risk of dementia in a group of more than 5,400 adults in the Netherlands, according to findings published July 2 in the journal BMC Medicine . That runs counter to two previous meta-analyses reporting increased dementia risk with benzodiazepine use, researchers noted. However, brain MRI scans taken of more than 4,800 participants revealed that benzodiazepine use is associated with accelerated shrinking of some brain regions, results show. The findings “support current guidelines cautioning against long-term benzodiazepine prescription,” concluded the research team led by Dr. Frank Wolters , a senior scientist of epidemiology and radiology and nuclear medicine at Erasmus Medical Center in the Netherlands. “Further research is needed to investigate the potential effects of benzodiazepine use on brain health,” the team adds. Benzodiazepines promote the release of a neurotransmitter that makes the nervous system less active, the Cleveland Clinic says. Different types are used as sedatives or to treat anxiety , insomnia and seizures. Analysis of medical records between 2005 and 2020 and pharmacy records between 1991 and 2008 revealed no association between benzodiazepines and increased risk of dementia, regardless of the total quantity of sedatives people took over time. The team also found no link between dementia risk and specific types of benzodiazepines or the time it took for dosages to wear off. However, benzodiazepine use was associated with an accelerated reduction in the volume of the hippocampus and amygdala, which are brain regions involved in memory and mood regulation. Certain types of benzodiazepines also were associated with changes in the size of white matter, which transmits nerve signals between brain regions, researchers said. Anxiolytic benzodiazepines prescribed for anxiety caused less shrinkage of white matter, results show. These include alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene) and lorazepam (Ativan, Loreev), according to the Cleveland Clinic. On the other hand, sedative-hypnotic benzodiazepines prescribed for sleep problems caused a quicker reduction in white matter volume. These include temazepam (Restoril), triazolam (Halcion) and quazepam (Doral), the Cleveland Clinic says. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

24 Jun 2024

·www.globenewswire.com

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com

Drug ApprovalClinical Result

100 Deals associated with Triazolam

External Link

KEGG	Wiki	ATC	Drug Bank
D00387	Triazolam	N05CD05	DB00897

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	Japan	Pfizer Japan, Inc.	15 Dec 1982
Sleep Initiation and Maintenance Disorders	United States	Pfizer Inc.	15 Nov 1982

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03246724 (CTgov)	Phase 4	Sedation	327	Sodium chloride 0.9%+Microcrystalline Cellulose+Triazolam+Midazolam (Cataract Procedures)	ururnbpjiu(owadkpyxgp) = xyeevzjhpt hfgeadkvyy (wafudogpvn, 0.57) View more	-	19 Aug 2020
				Sodium chloride 0.9%+Microcrystalline Cellulose+Triazolam+Midazolam (Retina Procedures)	ururnbpjiu(owadkpyxgp) = bjazvyltmw hfgeadkvyy (wafudogpvn, 0.72) View more
Pubmed \| J Endod	Phase 4	Pulpitis	60	Sublingual triazolam 0.25 mg	pjrbfdptfw(gbspdqahry) = sdhedtjjqv kyqtmofotm (lgoblhjhwc )	-	01 Oct 2008
				Placebo	pjrbfdptfw(gbspdqahry) = ipsvibllag kyqtmofotm (lgoblhjhwc )

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