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SONATA (ZALEPLON): SPECIAL POPULATIONS

Age

The pharmacokinetics of Sonata (Zaleplon) have been investigated in three studies with elderly men and women ranging in age from 65 to 85 years. The pharmacokinetics of Zaleplon in elderly subjects, including those over 75 years of age, are not significantly different from those in young healthy subjects.

Gender

There is no significant difference in the pharmacokinetics of Sonata (Zaleplon) capsules in men and women.

Race

The pharmacokinetics of zaleplon have been studied in Japanese subjects as representative of Asian populations. For this group, Cmax and AUC were increased 37% and 64%, respectively. This finding can likely be attributed to differences in body weight, or alternatively, may represent differences in enzyme activities resulting from differences in diet, environment, or other factors. The effects of race on pharmacokinetic characteristics in other ethnic groups have not been well characterized.

Hepatic impairment

Zaleplon (Sonata) is metabolized primarily by the liver and undergoes significant presystemic metabolism. Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively), in comparison with healthy subjects. The dose of Sonata should therefore be reduced in patients with mild to moderate hepatic impairment. Sonata (Zaleplon) capsules is not recommended for use in patients with severe hepatic impairment.

Renal impairment

Because renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose, the pharmacokinetics of zaleplon are not altered in patients with renal insufficiency. No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata has not been adequately studied in patients with severe renal impairment.

Drug-Drug Interactions

Because Zaleplon (Sonata) capsules is primarily metabolized by aldehyde oxidase, and to a lesser extent by CYP3A4, inhibitors of these enzymes might be expected to decrease zaleplon's clearance and inducers of these enzymes might be expected to increase its clearance. Zaleplon has been shown to have minimal effects on the kinetics of warfarin (both R- and S-forms), ethanol, imipramine, ibuprofen, thioridazine, diphenhydramine, and digoxin. However, the effects of zaleplon on inhibition of enzymes involved in the metabolism of other drugs have not been studied.

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