Oral Controlled Release Formulation for Sedatives and Hypnotic Agents

Abstract

The present invention relates to a novel controlled release dosage form that releases therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintains therapeutic levels for about eight hours after administration.

1 . A controlled release oral dosage form for sedatives and hypnotic agents that maintains therapeutic levels for about four to eight hours after administration to a patient and release less than 40% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37° C. 
   
   
       2 . The controlled release oral dosage form for sedatives and hypnotic agents as defined in  claim 1  wherein the dosage form releases not more than 35% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37° C. 
   
   
       3 . The controlled release oral dosage form for sedatives and hypnotic agents as defined in  claim 1  wherein the dosage form releases not more than 30% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37° C. 
   
   
       4 . The controlled release dosage form as defined by  claim 1  wherein the dosage form is a tablet. 
   
   
       5 . The controlled release dosage form as defined by  claim 4  wherein the dosage form is a matrix tablet coated with a pH dependent polymer. 
   
   
       6 . The controlled release dosage form as defined by  claim 1  wherein the dosage form is a capsule. 
   
   
       7 - 29 . (canceled)