Compared with nonelderly adults, subjects 65 years and older had longer elimination and higher total exposure to eszopiclone. Therefore, dose reduction is recommended in elderly patients [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Hepatic Impairment No dose adjustment is necessary for patients...
Data from the racemate, zopiclone, indicate that occasional use while breastfeeding an older infant should pose little risk to the infant. A safety scoring system finds zopiclone possible to use during breastfeeding,[1] but the infant should be monitored for sedation, poor feeding and poor ...
2 Special Populations NDA 21-476 Approved Labeling Text Dated December 15, 2004 Age Compared with non-elderly adults, subjects 65 years and older had an increase of 41% in total exposure (AUC) and a slightly prolonged elimination of eszopiclone (t1/2 approximately 9 hours). Cmax was ...