The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females

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Background: Zolpidem is currently approved for the treatment of patients with insomnia. Women reported experiencing an increased incidence of adverse effects than men, resulting in a reduction of the recommended dose of zolpidem for women. Zolpidem metabolism is affected by both age and gender; the ...

Background: Zolpidem is currently approved for the treatment of patients with insomnia. Women reported experiencing an increased incidence of adverse effects than men, resulting in a reduction of the recommended dose of zolpidem for women. Zolpidem metabolism is affected by both age and gender; the recommended dose for the elderly and female populations is 5mg daily. Subsequent studies have shown that women experience greater exposure to zolpidem than men, potentially due to androgen-driven differences in enzyme expression. A preclinical study showed that castrated male rats exhibited zolpidem pharmacokinetics similar to that of female rats, providing further evidence to suggest that zolpidem pharmacokinetics are androgen-driven. Objectives: -To evaluate the effect of castration on the pharmacokinetics of a single 5-mg dose of zolpidem in patients with prostate cancer undergoing androgen deprivation therapy (prevs. post-castration therapy) compared to normal healthy females. Eligibility: Patients with prostate cancer (rising PSA and greater than or equal to 100 ng/dL) Females in good health condition or without significant diseases After androgen deprivation therapy, castrate testosterone levels <50 ng/dL ECOG 0-1 Design: Comparative, single-dose pharmacokinetic study. Men with prostate cancer (pre-castration) and normal healthy females will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites. Men will then undergo androgen deprivation therapy and when castrate testosterone levels <50 ng/dL (post-castration), they will receive another 5 mg single dose of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites. Normal healthy females will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites.

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