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benzodiazepine

✓ Approved

Valenta Pharm · 小分子 · 小分子

什么是 benzodiazepine？

benzodiazepine 是一种小分子，由Valenta Pharm研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

公司Valenta Pharm
药物类别小分子
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Valenta Pharm

治疗适应症

benzodiazepine 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Psychiatric disordersAnxiety✓ Approved

相关研究文献

PubMedPublic health2026-09-10

Global prevalence and patterns of benzodiazepine use among adolescents and young adults: A systematic review and meta-analysis.

Ortega-Susín María José MJ, Pérez Teresa T, Serrano Dolores Remedios DR, González-Burgos Elena E

To synthesise global evidence on the prevalence, patterns of use, and clinical correlates of benzodiazepine (BZD) use among adolescents and young adults aged 16-30 years, and to identify methodological sources of heterogeneity in prevalence estimates across international settings. Systematic review and meta-analysis of observational studies. PubMed, Scopus, and Web of Science were searched for observational studies published between January 2015 and October 2025 reporting BZD use in individuals aged 16-30 years. Pooled prevalence was estimated using a random-effects model with Freeman-Tukey double arcsine transformation. Predefined exploratory subgroup analyses examined type of consumption, geographic region, data source, population type, and study size. Univariable meta-regression explored potential sources of heterogeneity. Risk of bias was assessed using the Hoy et al. tool. The protocol was registered in PROSPERO (CRD1230633). Fifteen studies (N = 7,235,912) were included. The pooled overall prevalence estimate was 4.4% (95% CI: 1.8 to 8.2%). Mixed medical/non-medical use yielded the highest estimate (5.9%), followed by medical use (3.6%) and misuse (3.3%). Exploratory subgroup analysis suggested differences by study size (p = 0.012), with small studies reporting higher prevalence estimates than medium-sized studies. Key correlates included female sex, psychiatric comorbidity (ADHD, depression), and polydrug use. Benzodiazepine exposure is common among adolescents and young adults. Prevalence appears context-dependent, likely reflecting differences in prescribing practices, access pathways, and exposure measurement across settings. These findings highlight the importance of developmentally tailored prescribing guidelines and suggest that expanding non-pharmacological alternatives may be warranted in this population.

PMID 42721645
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PubMedJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2026-09-10

Dual orexin receptor antagonist-assisted dose reduction of benzodiazepines and benzodiazepine receptor agonists: a mirror-image analysis of insurance claims data.

Matsui Kentaro K, Sugiura Ko K, Shimura Akiyoshi A, Takagi Shunsuke S et al.

Discontinuing benzodiazepines and benzodiazepine receptor agonists (BZ/BZRAs) remains challenging for patients with chronic insomnia despite safety concerns. This study evaluated whether continuous treatment with dual orexin receptor antagonists (DORAs) facilitates a reduction in BZ/BZRA doses among long-term users. This self-controlled (mirror-image) study, in which each patient served as their own control, used Japanese health insurance claims data (Dokenpo database, 2019-2024). Eligible patients had continuous BZ/BZRA use for ≥ 6 months and initiated suvorexant or lemborexant for ≥ 6 months. Changes in bedtime BZ/BZRA dose (diazepam equivalents) were compared between pre- and post-DORA periods. Logistic regression analyses identified factors associated with ≥ 50% dose reduction and BZ/BZRA discontinuation. Prior to DORA initiation, 605 patients were taking a mean of 1.9 ± 1.0 types of BZ/BZRAs at a pretreatment total daily dose of 8.2 ± 7.4 mg diazepam equivalent. Of these, 42.1% achieved ≥ 50% bedtime BZ/BZRA dose reduction and 21.3% achieved discontinuation. Mean bedtime doses decreased in both the suvorexant group (7.2 to 5.2 mg) and the lemborexant group (8.3 to 5.2 mg). In adjusted analyses, age ≥ 65 years was independently associated with both ≥ 50% reduction (odds ratio [OR] 2.485; 95% confidence interval [CI] 1.190-5.192; p = 0.015) and discontinuation (OR 2.636; 95% CI 1.158-6.000; p = 0.021). Lower pretreatment BZ/BZRA dose and lemborexant use were also associated with dose reduction and discontinuation. DORA treatment for at least six months may support BZ/BZRA dose reduction among long-term users, particularly in older patients. Discontinuing benzodiazepine and benzodiazepine receptor agonists (BZ/BZRAs) in patients with long-term use remains clinically challenging despite well-documented safety concerns. Whether sustained treatment with dual orexin receptor antagonists (DORAs) facilitates BZ/BZRA dose reduction in real-world practice has not been adequately examined in patients already exposed for six months or longer. Sustained DORA treatment for at least six months was associated with substantial bedtime BZ/BZRA dose reduction and discontinuation among long-term users, with older adults (aged 65 years or older) showing the highest odds of success. These findings support DORA co-administration as a practical pharmacological switching strategy to enable safer insomnia management, particularly in populations vulnerable to BZ/BZRA-related adverse events.

PMID 42717137
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PubMedDrug and alcohol review2026-09-10

Non-Prescribed Gabapentinoid Use: Demographic and Behavioural Risk Profiles in a Large International Sample.

Seddon Jennifer J, Barratt Monica J MJ, Puljević Cheneal C, Ferris Jason A JA et al.

The harm potential of gabapentinoids is well established, with concerns about non-medical use increasing alongside prescribing rates. However, less is known about the characteristics of people who use gabapentinoids obtained through non-prescribed routes. This study explored demographic and behavioural factors associated with gabapentinoid use, including differences between prescribed and non-prescribed sources. Data from the Global Drug Survey 2021 (N = 24,954). Multivariable logistic regression models identified correlates of: (i) past-year use; (ii) prescribed versus non-prescribed acquisition; and (iii) using gabapentinoids prescribed to others versus prescribed to oneself. Past-year gabapentinoid use was reported by 2.9% of respondents. In adjusted models, past-year use was associated with being a man, reporting a mental health or neurodevelopmental condition, use of benzodiazepines, opioids and illicit drugs. Among respondents who had ever used gabapentinoids (N = 1112), 45.6% reported using their own prescription, 27.2% used a non-prescribed source and 27.2% used medication prescribed to someone else. Non-prescribed use (i.e., not from a personal prescription) was more common among younger respondents, cis men and those reporting illicit drug or benzodiazepine use. Respondents with mental health or neurodevelopmental conditions were more likely to report prescribed use. A substantial proportion of gabapentinoid use occurs outside formal prescribing pathways, including use of medications prescribed to others. Non-prescribed use is embedded within broader substance use behaviours, highlighting specific demographic groups with higher odds of nonprescribed use. These findings underscore the importance of targeted harm-reduction responses and continued attention to diversion-prevention strategies.

PMID 42717568
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PubMedEuropean journal of clinical pharmacology2026-09-10

Clobazam in pediatric drug-resistant epilepsy: from pharmacology to clinical practice.

Wan Jun J, Yu Yupeng Y, Liu Xu X, Zeng Minling M et al.

To systematically review the current research progress on clobazam in pediatric antiepileptic therapy, focusing on its pharmacological mechanisms, pharmacokinetic properties, clinical efficacy, safety profile, and approaches to individualized treatment, with particular emphasis on the influence of CYP2C19 genetic polymorphisms on pharmacokinetics and therapeutic outcomes, and to provide a comprehensive reference for the rational clinical use of clobazam. This article comprehensively reviews the current research progress on clobazam in pediatric antiepileptic therapy, including evidence of efficacy across different epilepsy syndromes, strategies for managing drug-drug interactions, and individualized dosing regimens based on genotyping and therapeutic drug monitoring. Clobazam is a 1,5-benzodiazepine used as an antiseizure medication. Compared with classical 1,4-benzodiazepines, it demonstrates greater efficacy and fewer sedative adverse effects. Clobazam was approved by the U.S. Food and Drug Administration (FDA) in 2011 as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged ≥2 years. Since then, it has been increasingly used as adjunctive therapy for several pediatric epilepsy syndromes, including Dravet syndrome (DS), epilepsy with myoclonic-atonic seizures (EMAS), and epileptic encephalopathy with spike-wave activation during sleep. CYP2C19 genetic polymorphisms significantly influence its pharmacokinetics and therapeutic outcomes. Across the reviewed studies, adjunctive clobazam achieved ≥50% seizure reduction in approximately 53% of children and seizure freedom in approximately 24%. Efficacy was highest in LGS, supported by randomized controlled trials, while evidence for other syndromes was largely observational. CYP2C19 poor metabolizer status significantly increased N-desmethylclobazam exposure, supporting genotype-guided dose initiation. Clobazam demonstrates consistent efficacy as adjunctive therapy in pediatric drug-resistant epilepsy, with the strongest evidence supporting its use in LGS. Individualized treatment informed by CYP2C19 genotyping and therapeutic drug monitoring can optimize clinical outcomes. This review provides a comprehensive reference for the rational clinical use of clobazam.

PMID 42717028
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PubMedFrontiers in psychiatry2026-09-10

Acute catatonia and psychosis in the context of seizure exacerbation in epilepsy: a case report.

Alowais Maryam M, Khan Zainab Z, Salamah Fares F, Khalil Dania D et al.

The co-occurrence of seizure-associated psychosis and catatonia in epilepsy is diagnostically challenging, particularly when complex pre-existing psychiatric comorbidities complicate attribution. Few reports describe this triad in the context of an antidepressant switch. We report a 44-year-old woman with a 27-year history of epilepsy, maintained on carbamazepine and topiramate, and a longstanding psychiatric history of major depressive disorder, obsessive-compulsive symptoms, and chronic nihilistic delusions and intermittent hallucinations documented at baseline. One week before admission, her antidepressant was switched from clomipramine to venlafaxine 150 mg/day. Her caregiver reported increased seizure frequency, culminating in a breakthrough seizure 48 hours before presentation. She then developed acute mutism, food refusal, and unresponsiveness. On admission she met DSM-5-TR criteria for catatonia (mutism, stupor, posturing, waxy flexibility), which gradually resolved over the admission. Electroencephalography under sedation following benzodiazepine administration showed no epileptiform activity, though sensitivity for non-convulsive status epilepticus was limited. Electrocardiography demonstrated QTc prolongation (497 ms). Once verbal, the patient reported persecutory and nihilistic delusions, derealization, and auditory hallucinations. Management with escalating benzodiazepines and cautious antipsychotic uptitration (quetiapine XR, cariprazine) was associated with complete catatonic remission and psychotic symptom resolution over 29 days. This case illustrates the diagnostic uncertainty inherent in attributing acute psychiatric features to seizure activity when complex pre-existing psychiatric histories exist. The absence of a documented lucid interval and the presence of chronic baseline psychotic symptoms preclude a confident diagnosis of postictal psychosis; interictal psychosis or primary psychiatric disorder cannot be excluded. The case highlights underrecognized pharmacokinetic interactions between carbamazepine (a potent CYP3A4 inducer) and second-generation antipsychotics, and cardiac safety considerations during antipsychotic uptitration with QTc prolongation. The working discharge diagnosis was catatonic disorder due to another medical condition (epilepsy), with psychotic features of indeterminate classification. Clinicians should resist anchoring on temporal associations between seizure activity and psychiatric symptoms. EEG findings must be interpreted in their pharmacological context; pharmacokinetic interactions should inform antipsychotic dose selection; and QTc prolongation warrants structured cardiac monitoring.

PMID 42719603
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PubMedTrials2026-09-10

PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA): study protocol for a double-blind randomised controlled trial set in the UK.

Duffy Larisa L, Chew-Graham Carolyn A CA, Ching Brian C F BCF, Chipp Beverley B et al.

Generalised anxiety disorder (GAD) is common and increasingly recognised in primary care. Although antidepressants and psychological therapies are first-line treatments, many patients have residual anxiety and limited access to therapy. Evidence for effective next-step pharmacological options for treatment resistant anxiety remains limited. This paper describes the protocol for the PETRA trial, which will evaluate the clinical and cost-effectiveness of adding pregabalin to antidepressant treatment, compared with placebo, for people with GAD who have not responded or partially responded to antidepressant treatment. PETRA is a multicentre, individually randomised, double-blind, placebo-controlled superiority trial conducted in UK primary care. Participants are recruited by the study team from approximately 150 General Practices and randomised in a 1:1 ratio, using minimisation, to either pregabalin or a matching placebo for 26 weeks (followed by a tapering period where their dosage is reduced over approximately 4 weeks). Sample size is 498. Eligible participants are adults aged 18-74 years, who have been taking antidepressant medication for at least 8 weeks, received treatment with at least one other antidepressant before their current antidepressant and meet ICD-11 criteria for GAD and score ≥ 12 on the revised clinical interview schedule (CIS-R) total score. Follow-up assessments are at 3, 6, 12, 26 and ~ 30 weeks. Our primary outcome measure will be anxiety symptoms measured with GAD-7 at 12 weeks (continuous score). Secondary outcomes are anxiety (GAD-7) at other time points, depressive and panic symptoms, suicidal thoughts, self-rated global improvement, adherence to study medication, serious adverse events, adverse effects, alcohol consumption and benzodiazepine use, quality of life and resources and costs used. The ~ 30-week assessment will investigate symptoms during the withdrawal from pregabalin. Exploratory analyses will include cognitive tasks. A cost-effectiveness analysis and a nested qualitative study will evaluate the implementation and intervention acceptability. The trial findings will inform primary care prescribing practice by providing an accurate and generalisable estimate of the clinical and cost-effectiveness of prescribing pregabalin to individuals with generalised anxiety who have not responded or only partially responded to antidepressant treatment. Controlled Trials ISRCTN Registry, ISRCTN 16993990, registered on 19/09/2023. First participant enrolled in January 2024.

PMID 42717383
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