Schedules of Controlled Substances: Placement of Indiplon Into Schedule IV

This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5- a]pyrimidin-7- yl]phenyl]acetamide), including its salts, and all products containing indiplon into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and an evaluation of the relevant data by DEA. This scheduling of indiplon in schedule IV will not be finalized until a New Drug Application (NDA) for an indiplon product is approved by the Food and Drug Administration (FDA). If finalized, this action will impose the regulatory controls and criminal sanctions applicable to schedule IV non-narcotics on those who handle indiplon and products containing indiplon.