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Objectives: We studied the gender effects on the pharmacokinetics and pharmacodynamics of a single dose of nitrazepam in Japanese healthy volunteers.Methods: Eight healthy young females and males were included in a placebocontrolled double-blinded two-way cross-over study after giving written informed consent. The effects of a single dose of 5 mg nitrazepam were evaluated using computerized eye movement analysis and visual analogue scales (VAS) based on the classification of Norris et al. Blood samples were collected at the times indicated in the protocol and serum concentrations of nitrazepam were assayed by HPLC.Results: The time to reach maximum concentration of nitrazepam tended to be prolonged in females compared with males. The half-life of serum nitrazepam was significantly shorter in females than in males. There was no gender difference in the decrease of saccadic peak velocity after nitrazepam intake but its recovery to the baseline level tended to be delayed in females. Control values of smooth pursuit eye movement were significantly lower in females but the effect of nitrazepam was similar in both genders. The subjective effects of nitrazepam were marked in females on mental or physical sedation evaluated with VAS.Discussion: There were gender differences in some parameters of pharmacokinetics and pharmacodynamics of nitrazepam. The effects of menstrual cycle on the drug effects remain to be clarified. Since most medicines are applied to both males and females, we should accumulate more information on specific medicines in both males and females.

Gender Differences in Pharmacokinetics and Pharmacodynamics of Nitrazepam in Healthy Young Japanese Volunteers.