Methods and compositions for treating sleep apnea

Abstract

In general, the invention relates to pharmaceutical compositions comprising (R)-oxybutynin and a norepinephrine reuptake inhibitor (NRI) and methods of treating Sleep Apnea comprising administering (R)-oxybutynin and a norepinephrine reuptake inhibitor (NRI). In some embodiments, the NRI is atomoxetine.

What is claimed is: 
     
         1 . A method of treating a subject having a condition associated with pharyngeal airway collapse, the method comprising administering to a subject in need thereof an effective amount of (i) Atomoxetine and (ii) substantially enantiomerically pure (R)-oxybutynin. 
     
     
         2 .- 6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the Atomoxetine is administered at a dosage of from about 20 to about 100 mg. 
     
     
         8 .- 10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the (R)-oxybutynin is administered at a dosage of from about 2 to about 15 mg. 
     
     
         12 .- 13 . (canceled) 
     
     
         14 . The method of  claim 1 , wherein the condition associated with pharyngeal airway collapse is Sleep Apnea or Simple Snoring. 
     
     
         15 . The method of  claim 1 , wherein the condition associated with pharyngeal airway collapse is Obstructive Sleep Apnea (OSA). 
     
     
         16 . The method of  claim 1 , wherein the subject is in a non-fully conscious state, wherein the non-fully conscious state is sleep. 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein the NRI and (R)-oxybutynin are administered in a single composition, wherein the single composition is an oral administration form. 
     
     
         19 .- 41 . (canceled) 
     
     
         42 . A method of treating obstructive sleep apnea in a subject in need thereof, the method comprising administering to the subject an effective amount of (i) Atomoxetine and (ii) substantially enantiomerically pure (R)-oxybutynin. 
     
     
         43 . The method of  claim 42 , wherein the Atomoxetine is administered at a dosage of from about 20 to about 100 mg and the (R)-oxybutynin is administered at a dosage of from about 2 to about 15 mg. 
     
     
         44 . The method of  claim 42 , wherein the subject is in a non-fully conscious state, wherein the non-fully conscious state is sleep. 
     
     
         45 . The method of  claim 42 , wherein the NRI and (R)-oxybutynin are administered in a single composition, wherein the single composition is an oral administration form. 
     
     
         46 . A method of treating obstructive sleep apnea in a subject in need thereof, the method comprising decreasing an apnea-hypopnea index (AHI) of the subject by generating a circulating concentration of Atomoxetine and substantially enantiomerically pure (R)-oxybutynin in the subject that results in a decrease in AHI. 
     
     
         47 . A method of treating obstructive sleep apnea in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: a first active ingredient, a second active ingredient, and one or more pharmaceutically acceptable excipients; wherein the first active ingredient comprises Atomoxetine and the second active ingredient comprises (R)-oxybutynin, and wherein the (R)-oxybutynin is substantially enantiomerically pure.