Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Pharmacotherapeutic group: Benzodiazepine derivatives
ATC code: NO5CD05
Triazolam is a short-acting benzodiazepine with anticonvulsant anxiolytic, sedative, muscle relaxant and amnesic properties. It is used as a hypnotic in the short-term management of insomnia.
Triazolam is rapidly and nearly completely absorbed from the gastro-intestinal tract; peak plasma concentrations being achieved within 2 hours of administration by mouth.
Triazolam has a short plasma elimination half-life ranging from 1.5 to 5.5 hours. It is reported to be about 89% bound to plasma proteins. Triazolam undergoes hydroxylation in the liver and is excreted in the urine mainly in the form of its conjugated metabolites with only small amounts appearing unchanged.
No evidence of carcinogenic potential was observed in rats or mice during 24-month studies with triazolam at doses greater than or equal to 800 times the maximum human daily dose of 0.5 mg.
Triazolam was not mutagenic in the in vitro Ames bacterial reverse mutation assay, and no DNA damage was observed in an in vitro alkaline elution assay in Chinese hamster lung fibroblast cells.
In a one generation reproduction study, rats were administered triazolam in the diet at doses up to 5 mg/kg/day (greater than or equal to 100 times the maximum daily human dose). Female rats were dosed for 14 days before cohabitation, during gestation, and until 21 days post-parturition, and males were dosed for 60 days before cohabitation. There were no effects on mating or fertility at any dose.
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