Hypnotic compositions and methods of use thereof

Abstract

The present invention provides a chewing gum for treatment of sleep apnea. The chewing gum includes indiplon or a pharmaceutically acceptable salt thereof, a gum base, a protecting agent, a carbonate salt, a citrate salt, and a borate salt. The present invention also includes methods of treating narcolepsy, which include the step of administering a dosage form to a patient suffering from narcolepsy. The dosage form includes zopeclon or a pharmaceutically acceptable salt thereof, a bicarbonate salt, a metal oxide, and a phosphate salt. The dosage form could be a lyophilized powder or a chewing gum.

1 - 20 . (canceled) 
     
     
         21 . A chewing gum for treatment of sleep apnea, said chewing gum comprising:
 indiplon or a pharmaceutically acceptable salt thereof;   a gum base;   a protecting agent;   a carbonate salt;   a citrate salt; and   a borate salt.   
     
     
         22 . The chewing gum of  claim 21 , wherein the gum base comprises at least one hydrophobic polymer and at least one hydrophilic polymer. 
     
     
         23 . The chewing gum of  claim 22 , wherein the at least one hydrophobic polymer is a natural polymer selected from the group consisting of chicle, jelutong, gutta percha, crown gum, and combinations thereof. 
     
     
         24 . The chewing gum of  claim 22 , wherein the at least one hydrophobic polymer is a synthetic polymer selected from the group consisting of elastomers, rubbers, and combinations thereof. 
     
     
         25 . The chewing gum of  claim 24 , wherein the elastomer is selected from the group consisting of butadiene-styrene copolymers, isobutylene and isoprene copolymers, polyethylene, polyisobutylene, polyvinylester, and combinations thereof. 
     
     
         26 . The chewing gum of  claim 21 , further comprising a protecting agent. 
     
     
         27 . The chewing gum of  claim 26  wherein the protecting agent is selected from the group consisting of calcium stearate, glycerin monostearate, glyceryl behenate, glyceryl palmitostearate, hydrogenated castor oil, hydrogenated vegetable oil type I, light mineral oil, magnesium lauryl sulfate, magnesium stearate, mineral oil, poloxamer, polyethylene gycol, sodium benzoate, sodium chloride, sodium lauryl sulfate, stearic acid, cab-o-sil, talc, zinc stearate, and combinations thereof. 
     
     
         28 . A method for treating narcolepsy in a subject in need thereof comprising the step of:
 administering a lyophilized powder to the subject suffering from narcolepsy, wherein the lyophilized powder comprises   zopeclon or a pharmaceutically acceptable salt thereof;   a bicarbonate salt;   a metal oxide; and   a phosphate salt.   
     
     
         29 . A method for treating narcolepsy in a subject in need thereof comprising the step of:
 administering a chewing gum to the subject suffering from narcolepsy, wherein the chewing gum comprises   zopeclon or a pharmaceutically acceptable salt thereof;   a bicarbonate salt;   a metal oxide; and   a phosphate salt,   wherein the zopeclon is encapsulated in a centerfill, and   wherein the centerfill is surrounded at least in part by a gum base.   
     
     
         30 . The method of  claim 29 , wherein the centerfill is a liquid material. 
     
     
         31 . The method of  claim 29 , wherein the centerfill is a semi-liquid material. 
     
     
         32 . The method of  claim 29 , wherein the gum base comprises at least one hydrophobic polymer and at least one hydrophilic polymer. 
     
     
         33 . The method of  claim 32 , wherein the at least one hydrophobic polymer is a natural polymer selected from the group consisting of chicle, jelutong, gutta percha, crown gum, and combinations thereof. 
     
     
         34 . The method of  claim 32 , wherein the at least one hydrophobic polymer is a synthetic polymer selected from the group consisting of elastomers, rubbers, and combinations thereof. 
     
     
         35 . The method of  claim 34 , wherein the elastomer is selected from the group consisting of butadiene-styrene copolymers, isobutylene and isoprene copolymers, polyethylene, polyisobutylene, polyvinylester, and combinations thereof. 
     
     
         36 . The method of  claim 29 , wherein the chewing gum further comprises a protecting agent. 
     
     
         37 . The method of  claim 36 , wherein the protecting agent is selected from the group consisting of calcium stearate, glycerin monostearate, glyceryl behenate, glyceryl palmitostearate, hydrogenated castor oil, hydrogenated vegetable oil type I, light mineral oil, magnesium lauryl sulfate, magnesium stearate, mineral oil, poloxamer, polyethylene gycol, sodium benzoate, sodium chloride, sodium lauryl sulfate, stearic acid, cab-o-sil, talc, zinc stearate, and combinations thereof.