Alprazolam 500microgram tablets

Background/Objectives: Benzodiazepines (BZDs) are used routinely in cases requiring sedation for anxiety, insomnia, and procedures that require pain management, and daily use of these agents may extend over several months; therefore, monitoring patients is essential to reduce the risk of developing dependence. However, the high patient volume in pain and palliative-care settings often limits physicians’ ability to both conduct consultations and perform comprehensive evaluations. In this context, the pharmacist plays a key role in supporting patient care by contributing professional activities that enhance patient well-being, such as conducting systematic reviews of electronic medical records. This pharmacist-led EMR assessment enables the identification of benzodiazepine dependence patterns and supports a more robust epidemiological evaluation within the institution. Methods: A descriptive observational study (January 2022–May 2025) using electronic medical records and prescription data was conducted. Consecutive adults with an active BZD prescription and a documented BDEPQ-MX (Benzodiazepine Dependence Questionnaire, Mexican version) were included. Outcomes were BDEPQ-MX categories (No dependence; Pleasurable effects; Perceived need; Dependence) and a binary endpoint was stablished as “any dependence” (either scored in Perceived need or Dependence category) vs. No dependence (either scored as No dependence or Pleasurable effects categories). Group comparisons used χ2, Student’s t, and one-way ANOVA. A logistic regression modeled any dependence; a general linear model (GLM) examined the BDEPQ-MX total score. Results: Of 181 complete cases, BDEPQ-MX categories were No dependence 33.2% (60/181), Pleasurable effects 7.2% (13/181), Perceived need 17.1% (31/181), and Dependence 42.5% (77/181); hence, 59.7% met “any dependence.” Women comprised 67.4% overall. Compared with No dependence, the any-dependence group had higher comorbidity (83.3% vs. 65.8%, p = 0.006) and markedly greater duration of BZD use (months) (22.6 ± 11.5 vs. 5.9 ± 4.9, p < 0.001), with no difference in daily dose (p = 0.6). Benzodiazepine medications shifted toward alprazolam in dependence (38.9% vs. 20.5%, p = 0.009) and away from clonazepam (43.5% vs. 58.9%, p = 0.042). In the adjusted model, the male sex was associated with lower odds of any dependence (aOR 0.29, 95% CI 0.11–0.76; p = 0.013), while the duration of BZD use (per month) increased the odds (aOR 1.32, 1.20–1.45; p < 0.001). In the GLM, the duration showed the largest effect on BDEPQ-MX total (F = 203.26; p < 0.001; partial η2 = 0.545). Conclusions: In this outpatient pain and palliative-care population, benzodiazepine-related dependence phenomena were common: 59.7% of patients met the criteria for dependence based on the pharmacist-led EMR review. The involvement of the pharmacist was essential, as this systematic evaluation would have been difficult to perform within routine medical consultations. The pharmacist’s contribution enabled a detailed epidemiological characterization, revealing that the exposure duration—more than daily dose—was the principal, modifiable correlate of dependence, and that alprazolam was disproportionately represented in the higher-dependence categories. These findings underscore the value of pharmacist-supported surveillance to identify and measure BZD dependance.

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OBJECTIVE: Treatment options for seizure clusters are limited; the need for easy-to-administer treatments remains. The Staccato system delivers drug deep into the lung via inhalation. In this phase 2a study, we investigated the ability of three different doses of Staccato alprazolam to suppress the electroencephalographic (EEG) photoparoxysmal response (PPR) compared with placebo in participants with photosensitive seizures. METHODS: Adults (18-60 years) with a diagnosis and history of PPR on EEG with or without an epilepsy diagnosis were eligible to participate. Participants received Staccato alprazolam 0.5, 1.0, and 2.0 mg, and Staccato placebo (twice) in random order. Intermittent photic stimulation and clinical assessments were performed at one predose and seven postdose time points. The primary endpoint of the study was the change in standardized photosensitivity range (SPR) in participants receiving each dose of Staccato alprazolam. RESULTS: Fifteen participants with a prior epilepsy diagnosis were screened; five were enrolled, randomized, and completed the study. All participants were white females with a mean (SD) age of 27.2 (6.8) years. All doses of Staccato alprazolam reduced the SPR at 2 minutes; the effect was sustained through 4 hours for the 0.5-mg dose and 6 hours for the 1.0- and 2.0-mg doses. The magnitude and duration of sedation and sleepiness were dose-related. Four participants (80%) experienced ≥1 adverse event (AE); none was severe or serious. Cough, diarrhea, dysgeusia, oral dysesthesia, sedation, and somnolence were experienced by two participants (40%) each. SIGNIFICANCE: This proof-of-concept study demonstrated that Staccato alprazolam 0.5, 1.0, and 2.0 mg rapidly suppressed epileptiform activity in photosensitive participants with epilepsy. The AE profile of Staccato alprazolam was similar to what has been reported for alprazolam for other indications. The results support further development of Staccato alprazolam as a rescue medication for the acute treatment of seizures.

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Abstract Objective Staccato® alprazolam is a hand‐held inhalation device that provides rapid systemic delivery of alprazolam through the intrapulmonary route. This trial explored the pharmacokinetics and tolerability of single‐dose Staccato alprazolam 2 mg in adolescents with epilepsy. Pharmacokinetic data were included in a population pharmacokinetic analysis to support adolescent dose selection in the Phase 3 trials. Methods Multicenter, Phase 1, open‐label trial in adolescents (12–17 years) with focal, generalized, or focal and generalized epilepsy (UP0100/NCT04857307). A single dose of Staccato alprazolam 2 mg was administered in the morning following overnight fast. Pharmacokinetic data were used to update an existing population pharmacokinetic model in adults, which was used to investigate dosing in adolescents with epilepsy. Results Fourteen patients (6 weighing <50 kg, 8 weighing ≥50 kg) were enrolled and administered Staccato alprazolam 2 mg. Individual plasma alprazolam concentration−time profiles indicated generally rapid absorption (median time to maximum plasma concentration [ C max ]: 10.5 [range: 2–120] min) with linear elimination. Geometric mean C max , area under the plasma concentration–time curve (AUC) from time 0 to last quantifiable concentration (AUC 0–t ), AUC from time 0 to infinity (AUC inf ), and apparent total body clearance (CL/ F ) were similar across body weight groups (<50 kg, ≥50 kg). Three patients in the ≥50 kg group reported treatment‐emergent adverse events (TEAEs), including dysgeusia, somnolence, dizziness, cough, and hiccups. No severe or serious TEAEs were reported. Simulations of exposure estimates using the updated population pharmacokinetic model indicated similar exposure (AUC inf ) for adolescents administered Staccato alprazolam 2 mg compared with the adult reference range, with a slight increase in C max at lower body weight. Significance Alprazolam was rapidly absorbed in most adolescent patients with epilepsy following administration with the Staccato device. No clinically relevant differences between body weight groups were observed on primary pharmacokinetic or safety outcomes. Staccato alprazolam 2 mg was well tolerated. Overall, the present data support the use of Staccato alprazolam 2 mg in adolescents with epilepsy (12–17 years of age).

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BACKGROUND AND AIM: There is growing evidence of counterfeit benzodiazepine products containing other substances, including non-regulated benzodiazepine-type new psychoactive substances (NPSs). This study sought to compare detections of seized suspect counterfeit alprazolam products with clinical cases that reported use of an alprazolam-containing product to better characterise community use. DESIGN AND SETTING: Observational study set in Victoria, Australia, using data from the Victoria Police Drug Sciences Group (which compiles information about seized drugs submitted for evidential analysis and intelligence purposes) and the Emerging Drugs Network of Australia - Victoria (EDNAV) project (a prospective, observational study collecting clinical and analytical data for illicit drug-related presentations across a network of hospitals in Victoria, Australia). CASES: Police seizures expected to contain alprazolam (March 2020 and August 2022) and EDNAV cases with a reported exposure to an alprazolam-containing product (September 2020 and August 2022). MEASUREMENTS: Descriptive study outlining drug detections in seized tablets and blood samples from EDNAV cases, comparing patterns of detection and changes over time. FINDINGS: A total of 623 police seizures were analysed, most commonly products labelled as 'Xanax®' (n = 266), 'Kalma®' (n = 196) or 'Mylan®' (n = 124). Thirty percent of seizures contained alprazolam only. A benzodiazepine-type NPS was detected in 375 seizures (60.2%). Exposure to non-prescribed alprazolam was reported in 11.2% (n = 125/1112) of EDNAV cases, with 68.8% identifying as male and a median age of 26 years (range 16-68 years). Eighty-seven cases reported the use of 'Xanax®'. Alprazolam was detected in 19 EDNAV cases. A benzodiazepine-type NPS was detected in 78.4% of EDNAV cases. Both datasets saw a shift in detections from etizolam (2020) to clonazolam (2021) and then clobromazolam (2022). CONCLUSIONS: Suspect counterfeit alprazolam products seized by police in Victoria, Australia, in 2020 and 2022 commonly contained other drugs and/or new psychoactive substances, with an apparent limited consumer awareness of the tablet composition.

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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.

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