Anti-Trazodone polyclonal antibody

Introduction: REM sleep behaviour disorder (RBD) is characterised by violent behaviours (screaming, kicking, vivid dreams) during REM sleep. It has a prevalence of 1% to 2% of the general population and is especially frequent in men and the population older than 60. In the last decade, RBD has been suggested to be a prodrome of neurodegenerative disease. We analysed associated neurological diseases and responses to drug treatment in 33 patients with RBD treated in the multidisciplinary sleep disorders unit at Hospital Infanta Sofia. Patients and methods: We conducted an observational descriptive retrospective analysis of patients diagnosed with RBD and treated in our multidisciplinary sleep disorders unit between October 2012 and December 2015. We recorded age, sex, associated diseases, and treatments administered to these patients. Results: A total of 365 patients were attended at our unit, including 33 with RBD: 13 women (40%) and 20 men (60%). Mean age was 62.72 years. An associated disorder was identified in 48%, with the most common being mild cognitive impairment (69%). The percentage of patients with RBD and an associated disorder among patients older than 60 was 68%. Eighty-two percent of the patients required treatment. The most commonly used drug was clonazepam (76%), followed by melatonin (9%), gabapentin (6%), and trazodone (3%). Discussion: In our series, 48% of the patients had an associated disorder. The likelihood of detecting an associated disorder increases with patients' age. The vast majority of patients required drug treatment due to symptom severity; the most frequently administered drug was clonazepam (76%). (C) 2017 The Author(s). Published by Elsevier Espana, S.L.U. on behalf of Sociedad Espanola de Neurologia.

Objective: To assess the bioequivalence of single dose trazodone hydrochloride USP 100 mg tablets administered as an oral dose under fed condition. Methods: This study was an open-label, balanced, randomized, two-sequence, two treatment, two period, single oral dose, crossover bioequivalence study in healthy, adult, human subjects under fed conditions. After an overnight fast of at least 10 h, the subjects were served a high fat and high calorie vegetarian breakfast, which they were required to consume within 30 min. A single oral dose (100 mg) of either the test or the reference product was administered to the subjects. The primary pharmacokinetic parameters, maximum plasma concentration (C-max) and area under the plasma concentration time curve (AUG) from time zero to last measurable concentration (AUG(0-t)) and extrapolated to infinity (AUG(0-infinity)) were compared by an analysis of variance using log-transformed data. Bioequivalence was concluded if the 90% confidence intervals (CIs) of the adjusted geometric mean (gMean) ratios for C-max and AUG were within the predetermined range of 80-125%, in accordance with regulatory requirements. Results: For the test formulation, the trazodone gMean Cmax was 1480.9 ng/mL (vs. 1520.2 ng/mL for reference), AUG(0-t) was 18193.0 ng.h/mL (vs. 18209.8 ng.h/mL) and AUG(0-infinity) was 19346.3 ng.h/mL (vs. 19393.4 ng.h/mL). The 90% CIs for the ratio (test/reference) were 93.0-102.0% for C-max, 96.7-103.2% for AUC(0-t) and 96.1-103.5% for AUG(0-infinity). There were no deaths or serious adverse events during the conduct of the study. Conclusion: Test product when compared with the Reference product meets the bioequivalence criteria with respect to the extent of absorption of trazodone under fed condition.