Effects of Trazodone on Sleep: A Systematic Review and Meta-analysis

Kokkali, Maria; Pinioti, Elisavet; Lappas, Andreas S.; Christodoulou, Nikolaos; Samara, Myrto T.

doi:10.1007/s40263-024-01110-2

CNS Drugs

2024

DOI: 10.1007/s40263-024-01110-2

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Effects of Trazodone on Sleep: A Systematic Review and Meta-analysis

Maria Kokkali,

Elisavet Pinioti,

Andreas S. Lappas

et al.

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Cited by 1 publication

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Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers

Wang,

Xu,

Zhao

et al. 2024

Clinical Pharm in Drug Dev

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The aim of this study was to investigate the pharmacokinetics, bioequivalence, and safety of generic trazodone hydrochloride sustained‐release tablet and its reference listed product in healthy Chinese subjects. An open, randomized, single‐dose, and 2‐period crossover study was involved under fasting and fed conditions, with a 7‐day washout period. A single oral dose of 150 mg of 2 trazodone hydrochloride sustained‐release tablets was administered to 84 healthy volunteers, with 36 in the fasting group and 48 consuming a high‐fat diet, respectively. The plasma concentrations of trazodone were analyzed using a liquid chromatography‐tandem mass spectrometry method, and pharmacokinetic parameters were obtained from concentration‐time profiles. The geometric mean ratio with 90% confidence intervals of the maximum trazodone concentration, area under the plasma concentration‐time curve (AUC) from time 0 to the last measurable concentration, and AUC from time 0 to infinity were within the bioequivalence acceptance criteria (80%‐125%) under fasting and fed conditions, which indicated that the test and reference formulations were bioequivalent. Compared with the fasting study, the concomitant administration of trazodone with a high‐fat diet had a negligible influence on the drug pharmacokinetic behavior. Adverse events were recorded, and no serious adverse events were observed during either fasting or fed conditions. Trazodone has proven to have an acceptable safety profile in the Chinese population, with bioequivalence successfully established under both fasting and fed conditions.

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Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers

Wang,

Xu,

Zhao

et al. 2024

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

show abstract

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Effects of Trazodone on Sleep: A Systematic Review and Meta-analysis

Cited by 1 publication

References 90 publications

Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers

Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers

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