Patent ID: 6485746
Filing Date: 2002-11-26
Classification: A61K,B33Y,Y10S

Abstract:
A controlled-release formulation, comprising:(a) a sedative-hypnotic compound or precursor thereof that is metabolized to generate a sedative-hypnotic compound in vivo, wherein the compound has a mean plasma half life ranging from 0.1 to 2 hours; and (b) at least one release retardant such that, following administration of the formulation to a patient, the patient has in the following order: (i) a time to a first maximum plasma concentration (Tmax1) of the sedative-hypnotic compound ranging from 0.1 to 2 hours following administration; (ii) a time to a minimum plasma concentration (Tmin) of the sedative-hypnotic compound ranging from 2 to 4 hours, wherein the plasma concentration of the sedative-hypnotic compound at Tmin is less than 80% of the plasma concentration at Tmax1; (iii) a time to a second maximum plasma concentration (Tmax2) of the sedative-hypnotic ranging from 3 to 5 hours following administration, wherein the plasma concentration of the sedative-hypnotic compound at Tmax2 is from 80% to 150% of the plasma concentration at Tmax1; (iv) a plasma concentration of the sedative-hypnotic compound at 6 hours following administration of at least 20% of the plasma concentration at Tmax2; and (v) a plasma concentration of the sedative-hypnotic compound at 8 hours following administration of no more than 20% of the plasma concentration at Tmax2.