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benzodiazepine

✓ Approved

Valenta Pharm · Small Molecule · Small Molecule

What is benzodiazepine?

benzodiazepine is a small molecule developed by Valenta Pharm. It is approved for therapeutic indications via oral (po).

Drug Profile

CompanyValenta Pharm
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Valenta Pharm

Therapeutic Indications

benzodiazepine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersAnxiety✓ Approved

Related Research Articles

PubMedIntensive & critical care nursing2026-07-17

Brief, persistent, and recurrent delirium in a surgical ICU population: Incidence, risk factors, and short-term outcomes.

Guan Tingyu T, Chen Xizhu X, Zhu Airong A, Kang Yichen Y et al.

To identify the incidence, risk factors and short-term outcomes for brief, persistent, and recurrent courses of postoperative delirium in Intensive Care Unit (ICU) patients. This secondary analysis of the prospective PREDICt cohort included adult surgical ICU patients who developed postoperative delirium (POD). Delirium was classified as brief (≤1 day), persistent (>1 day), or recurrent (reappearance after ≥48 h of recovery). Demographic, perioperative, and postoperative variables were examined. Univariable comparisons and multivariable logistic regression were performed to identify risk factors for delirium courses, with variables yielding p < 0.2 in the univariable analysis entered into the multivariable model. Among the 272 patients with POD, 96 experienced brief delirium, 156 persistent delirium, and 20 recurrent delirium. Compared with brief delirium, recurrent delirium was independently associated with lower ADL scores (OR = 0.98, 95% CI: 0.96-0.99), postoperative blood transfusion within 24 h of ICU admission (OR = 4.71, 95% CI: 1.46-15.24), and benzodiazepine exposure (OR = 9.33, 95% CI: 1.91-45.48). Given the wide confidence intervals and the small number of recurrent cases, all estimates for the recurrent delirium subgroup should be considered hypothesis-generating. Persistent delirium was associated with fewer years of education (OR = 0.92, 95% CI: 0.86-0.98) and lower ADL scores (OR = 0.99, 95% CI: 0.98-0.99). Persistent and recurrent delirium were associated with worse clinical outcomes than brief delirium, including longer mechanical ventilation duration, prolonged ICU stay, and higher in-hospital mortality. Delirium courses differ in risk factors and prognosis. Persistent delirium was associated with lower preoperative ADL scores and fewer years of education, while recurrence was associated with lower ADL scores, postoperative blood transfusion, and benzodiazepine exposure. Recurrent delirium carried the worst outcomes, including prolonged ventilation, extended ICU stay, and higher mortality. Recognizing delirium as a dynamic process rather than a transient event underscores the need for course-based risk stratification. Early identification of high-risk patients and modification of exposures, such as transfusion and benzodiazepine use, may help prevent persistent and recurrent delirium and improve outcomes.

PMID 42462540
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PubMedThe lancet. Healthy longevity2026-07-17

Risk of fracture with gabapentinoid treatment in older adults: a multinational population-based study.

Yuen Andrew S C ASC, Chen Boqing B, Chan Adrienne Y L AYL, Hong Bin B et al.

Gabapentinoids are increasingly being prescribed in older adults (aged 60 years or older), but concerns have been raised that their adverse effects on the CNS can increase the risk of fractures. Previous studies have reported associations between gabapentinoid use and fracture, but many have not adequately addressed confounding by indication or examined risk across the treatment journey. Therefore, we aimed to investigate the temporal association between gabapentinoid treatment and fracture in older adults, and to assess whether concomitant opioid or benzodiazepine use further modifies this risk. In this retrospective multinational population-based study, we used data from the UK Clinical Practice Research Datalink (CPRD) Aurum database and the South Korea National Health Insurance Service-National Health Screening Cohort (NHIS-HEALS). The analysis included individuals aged 60 years or older prescribed a gabapentinoid and who had a hospitalised fracture between Jan 1, 2010, and Dec 31, 2020, in the UK and between Jan 1, 2003, and Dec 31, 2019, in South Korea. The observation period for each included individual was divided into four mutually exclusive windows: 90 days before gabapentinoid treatment (pre-exposure window), first 60 days of treatment period (focal window 1), remaining time of the treatment period (focal window 2), and all other non-treatment periods (referent window), to capture how risk varied across the treatment course. Adjusted incidence rate ratios (aIRRs) with 95% CI of fracture during different risk windows were estimated using conditional Poisson models within each country, and the country-specific aIRRs for the same risk window were then pooled using a random-effects model. We included 20 030 participants in CPRD and 2935 in NHIS-HEALS in the analysis. In the CPRD cohort, 15 366 (76·7%) were women and the mean age at event was 77·85 years. In the NHIS-HEALS cohort, 2007 (68·4%) were women and the mean age at event was 69·24 years. The pooled results showed an increased risk of fracture during the pre-exposure window (aIRR 2·92, 95% CI 1·61-5·28, p=0·0004). The aIRR was 1·31 (95% CI 1·00-1·71, p=0·051) in the first 60 days of the treatment period and did not increase for the remainder of the treatment period (0·84, 0·54-1·32, p=0·45). Concurrent prescription of opioids or benzodiazepines elevated the risk of fracture, with an aIRR of 3·15 (95% CI 2·85-3·48, p<0·0001) for opioids and 1·91 (1·50-2·44, p<0·0001) for benzodiazepines during the first 60 days of gabapentinoid treatment period. The risk of fracture was the highest in the period before the commencement of gabapentinoid treatment and declined after initiation of treatment. The results do not support a sustained causal relationship between gabapentinoid use and risk of fracture in older adults but warrant fall and fracture-prevention measures around gabapentinoid initiation. The elevated fracture risk observed with concomitant opioid or benzodiazepine use highlights the need for careful review of concurrent sedating medicines when initiating gabapentinoids. UK National Institute for Health and Care Research; Hong Kong Innovation and Technology Commission; Ministry of Food and Drug Safety, South Korea.

PMID 42462752
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PubMedJournal of veterinary pharmacology and therapeutics2026-07-17

Residue Kinetics and Dietary Risk Assessment of Diazepam and Its Metabolites in Grass Carp (Ctenopharyngodon idella): Implications for Aquaculture Safety.

Shan Qi Q, Xu Feng F, Wu Mingyuan M, Zhou Hao H et al.

Diazepam (DZP), a benzodiazepine sedative, has been increasingly detected in various aquatic products including fish, shrimp, and crab in recent surveillance studies, raising public health concerns. This study systematically investigates the residue behavior, metabolite profile, and dietary risk of DZP in grass carp (Ctenopharyngodon idella) following oral administration at a dose of 500 μg/kg body weight. Concentrations of DZP and its metabolites in plasma and tissues were determined using ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and the drug concentration-time data were fitted using a non-compartmental model embedded in WinNonLin 6.1 pharmacokinetic software. The results indicate that DZP exhibits prolonged elimination kinetics, with tissue elimination half-lives (T1/2λz) ranging from 309.44 to 509.75 h, and residues in skin-on muscle did not fall below the limit of quantification until 98 days. Metabolite analysis identified nordiazepam as the primary metabolite, with its concentration surpassing that of the parent compound by Day 21 post-administration, establishing it as a reliable residue marker for DZP in grass carp. The peak human health risk index (HRI) value was 0.392 on Day 4, remaining above the alert threshold (HRI ≥ 0.1) for 21 days, though all values remained below the safety limit (HRI < 1). These findings provide critical data to support the regulation of aquaculture practices and the assessment of dietary exposure risks associated with DZP-contaminated aquatic products.

PMID 42466529
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PubMedRespiratory investigation2026-07-17

Association between fentanyl dose and willingness to undergo repeat bronchoscopy in a standardized EBUS-GS-TBB setting.

Monden Kazuya K, Akamatsu Ayumi A, Takada Yohei Y, Totani Risa R et al.

Discomfort experienced during bronchoscopy may limit patients' willingness to undergo repeat procedures. Although guidelines recommend benzodiazepine-opioid sedation, evidence regarding optimal opioid dosing remains limited. We evaluated whether the total fentanyl dose was associated with willingness to undergo repeat bronchoscopy in a standardized endobronchial ultrasonography with guide-sheath transbronchial biopsy (EBUS-GS-TBB) setting. We conducted a retrospective single-center study of consecutive patients who underwent radial endobronchial ultrasonography with guide-sheath transbronchial biopsy. Patients were categorized by fentanyl dose: none (0 μg), low (1-49 μg), and moderate (≥50 μg). The primary outcome was willingness to undergo repeat bronchoscopy, assessed on a 5-point Likert scale (lower scores indicate greater willingness). Ordinal logistic regression was conducted using complete case analysis. Sensitivity analyses were conducted using alternative dose thresholds and continuous dose modeling. Among 300 patients with evaluable primary outcome data, moderate-dose fentanyl was independently associated with greater willingness to undergo repeat bronchoscopy (adjusted odds ratio, 0.49; 95% confidence interval, 0.27-0.91), whereas low-dose fentanyl was not. The associations remained consistent in direction across different categorizations, and the continuous model demonstrated a dose-response relationship. Severe adverse events included two cases of pneumothorax requiring chest drainage in the moderate-dose group; no other severe events were noted. In this standardized EBUS-GS-TBB setting, moderate-dose fentanyl was associated with greater willingness to undergo repeat bronchoscopy. These findings suggest that willingness to undergo repeat bronchoscopy may depend not only on opioid use, but also on how opioids are titrated.

PMID 42462404
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PubMedAnaesthesia2026-07-17

Remimazolam vs. propofol anaesthesia for delirium in older patients recovering from lung resections: a randomised non-inferiority trial.

Wang Wei W, Zhang Fengping F, Ge Yi Y, Zhang Yunyun Y et al.

Remimazolam tosylate is an ultra-short-acting benzodiazepine sedative and anaesthetic. The related drug, midazolam, is associated with delirium but it remains unclear whether remimazolam also promotes delirium. We tested the primary hypothesis that remimazolam is non-inferior to propofol for delirium in patients during the initial 3 days after lung resection surgery. Secondary outcomes were the proportion of delirium-positive assessments; duration of stay in the post-anaesthesia care unit; and hospital and Mini-mental State Examination scores at 30 days. We randomly allocated patients aged ≥ 65 y to remimazolam or propofol anaesthesia for lung resection surgery. Delirium was assessed by trained assessors blinded to trial treatment using the Confusion Assessment Method in the post-anaesthesia care unit and twice daily for 3 postoperative days. Our non-inferiority margin was a 10% absolute difference in the incidence of postoperative delirium. The modified intent-to-treat population included 455 patients. Delirium occurred in 108/227 (48%) patients allocated to the remimazolam group and 71/228 (31%) in those allocated to the propofol group (risk ratio 1.53, 95%CI 1.21-1.94). The absolute risk difference was 16.5% (95%CI 7.7-25.3%) which considerably exceeded our non-inferiority margin; therefore, non-inferiority was not established. Emergence delirium was more frequent in patients allocated to remimazolam (105/227 (46%) vs. 64/228 (28%); risk ratio 1.65, 95%CI 1.28-2.12), whereas delirium after post-anaesthesia care unit discharge was uncommon and similar between groups (9/227 (4%) vs. 12/228 (5%); risk ratio 0.75, 95%CI 0.32-1.75). Delirium-positive assessments occurred in 129/1377 (9%) patients allocated to the remimazolam group and 102/1440 (7%) in those allocated to the propofol group (risk ratio 1.36, 95%CI 0.96-1.91). Remimazolam was not non-inferior to propofol for postoperative delirium in older patients having lung resection surgery and provoked more emergence delirium.

PMID 42464898
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PubMedNeuro endocrinology letters2026-07-16

Sedation Dose of Remimazolam for Older Adults Undergoing Hip Arthroplasty with Neuraxial Anesthesia and Its Impact on Postoperative Delirium.

Hou Yan-Qi YQ, Li Tu-Ping TP, Ma Zhi-Cong ZC

Remimazolam tosylate is an ultra‑short‑acting benzodiazepine sedative. This study aimed to determine a suitable intraoperative remimazolam dose for older adults undergoing hip arthroplasty with neuraxial anesthesia and to explore its association with postoperative delirium (POD) and perioperative stress responses. In this randomized study, 153 older adults undergoing hip arthroplasty with neuraxial anesthesia were allocated to four groups: saline control (N), remimazolam 0.1 mg/(kg•h) (R1), 0.2 mg/(kg•h) (R2), and 0.3 mg/(kg•h) (R3). Primary outcomes were intraoperative sedation success (modified Observer's Assessment of Alertness/Sedation scale), plasma cortisol and norepinephrine concentrations at operating room entry and exit, and incidence of POD. In the R2 group, sedation success was 100%, and the mean awakening time was 6.82 ± 0.64 min, shorter than in the R3 group (8.16 ± 0.93 min), which exhibited deeper sedation and longer recovery. No statistically significant differences were observed in POD incidence across groups (2.86-6.00%; p = 0.922), and the study was underpowered to detect modest between‑group differences. Compared with saline, the remimazolam groups had lower cortisol and norepinephrine concentrations at operating room exit, whereas within‑group changes from entry to exit did not reach statistical significance (p > 0.05). Compared with saline, the remimazolam groups had lower cortisol and norepinephrine concentrations at operating room exit, whereas within‑group changes from entry to exit did not reach statistical significance (p > 0.05). Within the observed POD incidence range (2.86-6.00%), remimazolam did not appear to increase POD over the first 7 postoperative days compared with saline, although the study was not powered to detect modest differences.

PMID 42460912
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