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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

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Psychiatric disordersAnxiety✓ Approved

Related Research Articles

PubMedPharmacoepidemiology and drug safety2026-08-30

Postpartum Psychotropic Treatment Patterns and Breastfeeding: Nationwide Clustering Study.

Hviid Anders A, Laksafoss Anna A, O'Regan Elisabeth E, Videbech Poul P et al.

Postpartum psychotropic medication use is heterogeneous, comprising continuation of prenatal treatment, initiation, transient use and complex polypharmacy. Prior studies have reported the prevalence of potential infant exposure to psychotropics via breast milk, but characterisations better capturing the heterogeneity of this exposure are lacking. We aimed to identify distinct postpartum psychotropic treatment patterns using hierarchical clustering accounting for medication type, timing and polypharmacy, and to describe breastfeeding characteristics across these patterns. Population-based cohort study of mothers using psychotropics during the first postpartum year using linked Danish national registers 2012-2023. From a source population of 659 866 mother-child pairs with live-born singleton births, 38 528 mothers redeemed at least one psychotropic prescription during the first postpartum year and comprised the study cohort. Weekly psychotropic use was defined by redeemed prescriptions using prescribed daily dose assumptions. Hierarchical agglomerative clustering (tame R package) identified distinct treatment patterns based on medication type, timing and polypharmacy. The number of patterns was determined from interpretability, size and examination of the hierarchical dendrogram. Exclusive breastfeeding prevalence and duration were described across patterns among pairs with recorded breastfeeding habits (64%). Eight distinct treatment patterns were identified, differing in psychotropic type, timing and polypharmacy. Three SSRI-dominated patterns (24 225 pairs, 63%) ranged from increasing SSRI use (Pattern I; n = 11 731), through continued SSRI use with high persistence (Pattern II; n = 7167), to mixed use involving SSRIs and other psychotropics (Pattern III; n = 5327; 48% using three or more medications). The remaining five patterns (14 303 pairs, 37%) were dominated by benzodiazepine-related drugs, other antidepressants, centrally acting sympathomimetics, antipsychotics or complex mixed use, ranging from late-initiated benzodiazepine-related use (Pattern IV; median initiation Week 27; persistence 13%) to early-initiated, highly persistent mixed use (Pattern VIII; median initiation Week 4; persistence 94%). Exclusive breastfeeding duration varied across patterns, with long-duration exclusive breastfeeding (181 days or more) highest in the SSRI-continued pattern (Pattern II, 10.6%) and lowest in the mixed-use-increasing and antipsychotics-sporadic patterns (Patterns III and VII, 5.1% and 5.2%). Postpartum psychotropic treatment patterns are clinically heterogeneous and exclusive breastfeeding practices differ across treatment patterns.

PubMedEuropean journal of clinical pharmacology2026-08-28

Prescription duration of benzodiazepines: a retrospective cohort study of prescription duration in primary care.

Trimm Kevin K, Moraga Maria-Teresa MT, Knäuper Bärbel B, Rahme Elham E et al.

Benzodiazepines are approved for and used in the treatment of anxiety, insomnia, seizures, and alcohol withdrawal. However, benzodiazepine prescriptions often do not align with regulatory approved (i.e. "on-label") indications, or duration, which can result in serious adverse drug events, especially among older people. Benzodiazepine labels universally warn against long-term use due to known adverse effects, dependence, and withdrawal symptoms. It is therefore important to understand factors associated with durations longer than regulators approved (i.e. "off-label" duration). This can be challenging due to a lack of data on prescribed duration of treatment and treatment indication. The aim of this study is to identify risk factors for long-term benzodiazepine use. Data from the MOXXI (Medical Office of the XXIst century) electronic health record system in Quebec Canada was used to collect benzodiazepine prescription indication and duration, which was then integrated with the public pharmacare system to determine dispensation in the period between December 17th, 2002 and December 31st, 2023. The entire dataset was used. Each drug indication and duration was retrospectively classified as either on-label or off-label, and short-duration (≤30 days) or long-duration (>30 days) according to the Health Canada drug database. To assess determinants of long-term use, a multi-level approach was used, with the patient-drug indication pair as the unit of analysis. Duration of prescription was evaluated as the outcome. 69.2% of benzodiazepines were prescribed long-term. The odds of being prescribed a benzodiazepine long-term increased with age (1.01 (1.01-1.01) per year) and was more probable for male patients (1.13 (1.04-1.22)) than female. Patients taking concomitant medication are more likely to be prescribed benzodiazepines long-term (1.05 (1.04-1.07)) per additional medication. Male physicians were more likely to prescribe benzodiazepines long-term (1.29 (1.19-1.40)), and there was a significant relationship between institution of medical school training and long-term benzodiazepine prescribing behavior. Off-label benzodiazepines were less likely to be prescribed long-term compared to on-label benzodiazepines (0.81 (0.76-0.87)). Using 21 years of indication-linked e-prescribing and pharmacare data, we found benzodiazepines were rarely limited to short-term use. Older age and an increasing number of concomitant medication were associated with long-term use. These findings underscore the need for prescriber education and highlight e-prescribing systems' value for monitoring and improving prescribing behavior.

PubMedTherapie2026-08-28

Characteristics of patients with opioid/benzodiazepine use disorder in a specialized consultation unit for prescription drug addiction: A cross-sectional study.

Merah Ismahane I, de Ternay Julia J, Veseli Anjesa A, Chinoune Wafae W et al.

The "Centre Ressource Lyonnais des Addictions Médicamenteuses" (CERLAM), i.e., Lyon Resource Center for Prescription Drug Addiction, is a specialized addiction unit for all types of prescription drug use disorders. Using the structured initial assessment of the center, the specific profile of patients with prescription opioid (OUD) or benzodiazepine use disorder (BUD) was explored. The structured initial CERLAM assessment includes age, gender, international standardized classification of education (ISCED), DSM-5 criteria for OUD or BUD, Hospital Anxiety and Depression Scale (HADS), World Health Organization Quality of Life - 26-item version (WHOQOL-BREF), and Pittsburgh Sleep Quality Inventory (PSQI), respectively. Two multivariable logistic regression models explored the profile of OUD (vs. non-OUD) patients and BUD (vs. non-BUD patients), providing adjusted odds ratios and their 95% confidence intervals (aOR[95%CI]). One hundred and eighty-four patients were included (54.9% females; mean age 44.7±13.4 years), among whom 107 (58.2%) had an OUD, and 86 (46.7%) a BUD. When compared with non-OUD patients, those with prescription OUD were more frequently females (aOR=1.97 [1.04-3.73]), had a lower ISCED (aOR=0.55 [0.42-0.72]), and a lower physical WHOQOL-BREF score (aOR=0.93 [0.88-0.99]). By contrast, when compared with non-BUD patients, those with BUD had a greater ISCED (aOR=2.04 [1.54-2.72]), reduced psychological (aOR=0.93 [0.87-0.99]) and social (aOR=0.86 [0.76-0.96]) WHOQOL-BREF scores, greater HAD depression (aOR=1.10 [1.03-1.18]) and PSQI (aOR=1.13 [1.04-1.23]) scores, respectively. In patients with prescription drug use disorders, those with BUD and those with OUD exhibit specific sociodemographic and psychological features, that need to be identified and treated independently.

PubMedPharmaceuticals (Basel, Switzerland)2026-08-27

Differential Dose-Response Behavioural Profiles of Diazepam, Zolpidem and Indiplon in a Two-Trial Y-Maze Paradigm in Rats.

Moraru Miruna Valeria MV, Coman Oana Andreia OA, Zugravu Aurelian A, Stoleru Smaranda S et al.

Background: Benzodiazepines and non-benzodiazepine hypnotics (Z-drugs) act at the benzodiazepine binding site of GABAA receptors but differ in their receptor subtype selectivity and behavioural profiles. Diazepam acts as a non-selective positive allosteric modulator of benzodiazepine-sensitive GABAA receptors, whereas zolpidem and indiplon display preferential affinity for α1-containing receptor subtypes. Although these compounds have been investigated individually in experimental models of exploratory behaviour and cognition, comparative behavioural data obtained using the same experimental protocol remain limited. Methods: This study evaluated the behavioural effects of diazepam, zolpidem and indiplon in male Wistar rats using a two-trial Y-maze paradigm with a 24 h retention interval. Animals received one of three dose levels of each compound before the acquisition trial. Recall-phase behaviour was evaluated using conventional exploration measures together with time- and entry-based preference indices for the previously inaccessible arm. Primary analyses were performed separately for each compound using one-way ANOVA with appropriate post hoc comparisons. Complementary exploratory factorial analyses were subsequently conducted to examine overall behavioural patterns across drug and nominal dose categories. Results: Diazepam produced marked dose-dependent reductions in recall-phase exploration of the previously inaccessible arm and in both exploratory preference indices. In contrast, zolpidem and indiplon reduced exploratory activity during the acquisition phase without significantly affecting recall-phase exploratory behaviour. The complementary factorial analyses identified significant Drug × Nominal Dose Categories interactions across all recall-related endpoints, indicating that behavioural responses across the nominal dose categories differed among the three compound-specific experimental series. The strongest interaction effects were observed for Time Index % (F(6,72) = 10.522, p < 0.001, ηp2 = 0.467) and Entries Index % (F(6,72) = 6.870, p < 0.001, ηp2 = 0.364). Conclusions: Diazepam produced more pronounced dose-dependent alterations in recall-phase exploratory behaviour than zolpidem or indiplon in the experimental conditions employed. The complementary factorial analyses support the interpretation that the three compounds exhibited different behavioural patterns across the nominal dose categories evaluated, while these exploratory comparisons should be interpreted within the constraints of the study design. Overall, the findings contribute to the comparative behavioural characterization of benzodiazepine-site modulators in the two-trial Y-maze paradigm.

PubMedScandinavian journal of gastroenterology2026-08-27

Comparative study on the efficacy and safety of remimazolam versus midazolam for sedation during ERCP-related procedures in the elderly.

Ito Suguru S, Tanisaka Yuki Y, Ryozawa Shomei S, Mizuide Masafumi M et al.

Benzodiazepine agonists, commonly used sedatives for endoscopic retrograde cholangiopancreatography (ERCP) in Japan, may cause prolonged sedation, particularly in elderly patients. Although remimazolam, an ultra-short-acting benzodiazepine, has been approved for endoscopic sedation, its efficacy and safety in elderly patients remain unclear. We compared remimazolam and midazolam for sedation during ERCP-related procedures in patients aged ≥75 years. This retrospective study included 208 patients aged ≥75 years: remimazolam group (R group, n = 106) and midazolam group (M group, n = 102). The primary outcome was the time to recovery (Aldrete score ≥9). Secondary outcomes included sedation success rate, number of doses, total doses administered, incidence of agitation requiring procedure interruption, procedure time, flumazenil use, and sedation-related adverse events. Recovery time was significantly shorter in the R group (median, 2 vs. 4 min, p <.01). Flumazenil use was significantly lower (4.7% vs. 28.4%, p <.01). The total number of doses administered was significantly higher in the R group (median, 3 vs. 2 times, p < .01). No significant differences were observed in sedation success rate, agitation requiring procedure interruption, procedure time, and sedation-related adverse events. Remimazolam significantly shortened recovery time and reduced flumazenil use in elderly patients, which may reduce staff workload after ERCP; larger studies are needed to establish comparative safety.

PubMedPharmaceuticals (Basel, Switzerland)2026-08-27

Volumetric Absorptive Microsampling (VAMS) for Therapeutic Drug Monitoring of Antiseizure Medications (ASMs) in Pediatric Patients.

Simeoli Raffaele R, Mancini Alessandro A, Cairoli Sara S, Rossi Chiara C et al.

Background: Volumetric absorptive microsampling (VAMS) is an emerging tool for therapeutic drug monitoring (TDM) of several drugs including antiseizure medications (ASMs). Here, we compared the concentrations of carbamazepine (CBZ), levetiracetam (LEV), lacosamide (LCS), topiramate (TPR) and the benzodiazepine (BZ) clobazam (CLB) in plasma and VAMS samples. Methods: VAMS samples were collected by fingerprick in pediatric patients followed at our center. Patients were also subjected to conventional venous blood sampling. Plasma and VAMS samples were analyzed by using a UHPLC-MS/MS validated kit for AEs and BZs (ClinMass LC-MS/MS Complete Kit®). A cross-validation analysis was performed by using Spearman correlation (rho), Deming regression and Bland-Altman plots. Results: Two analytical methods for measuring selected AEs and BZs in VAMS samples were developed and validated in accordance with the ICH M10 guidelines. Based on Bland-Altman results, a satisfactory agreement was observed between VAMS and plasma for CBZ, LCS, TPR, LEV and N-CLB. Considering the absence of interchangeability between capillary blood and plasma levels for CBZ-Diol, -Epoxi and CLB, a blood to plasma ratio was used to convert VAMS values into estimated plasma concentrations. Comparison of estimated vs. observed plasma results showed a successful predictive performance for this conversion approach. Conclusions: A positive agreement between plasma and VAMS was found for CBZ, LCS, TPR, LEV and N-CLB. Conversely, a conversion factor based on blood to plasma ratio should be adopted to convert CBZ-Diol, -Epoxi and CLB VAMS results into estimated plasma concentrations. This study confirmed the utility of VAMS for TDM of selected ASMs in pediatric patients during routine clinical practice.

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