Methods of making and using N-desmethylzopiclone

Abstract

The invention is directed to compositions comprising, and methods of using, racemic N-desmethylzopiclone, optically pure (+)-N-desmethylzopiclone, and optically pure (−)-N-desmethylzopiclone in the treatment and prevention of diseases and conditions in mammals. The invention is further directed to novel methods of preparing N-desmethylzopiclone, optically pure (+)-N-desmethylzopiclone, and optically pure (−)-N-desmethylzopiclone.

1 - 7 . (canceled)  
   
   
       8 . A method of treating or preventing an affective disorder in a patient, which comprises administering to a patient suffering from an affective disorder a therapeutically or prophylactically effective amount of N-desmethylzopiclone, or a pharmaceutically acceptable salt, solvate, hydrate, or clathrate thereof.  
   
   
       9 . The method of  claim 8 , wherein the affective disorder is depression.  
   
   
       10 . The method of  claim 8 , wherein the affective disorder is attention deficit disorder or attention deficit disorder with hyperactivity.  
   
   
       11 - 19 . (canceled)  
   
   
       20 . The method of  claim 8 , wherein the N-desmethylzopiclone is racemic.  
   
   
       21 . The method of  claim 8  wherein the N-desmethylzopiclone is (+)-N-desmethylzopiclone, substantially free of its (−) enantiomer.  
   
   
       22 . The method of  claim 8  wherein the N-desmethylzopiclone is (−)-N-desmethylzopiclone, substantially free of its (+) enantiomer.  
   
   
       23 . The method of  claim 21  wherein the amount of (+)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 90% by weight of the total amount of N-desmethylzopiclone.  
   
   
       24 . The method of  claim 22  wherein the amount of (−)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 90% by weight of the total amount N-desmethylzopiclone.  
   
   
       25 . The method of  claim 23  wherein the amount of (+)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 95% by weight of the total amount N-desmethylzopiclone.  
   
   
       26 . The method of  claim 24  wherein the amount of (−)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 95% by weight of the total amount N-desmethylzopiclone.  
   
   
       27 . The method of  claim 25  wherein the amount of (+)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 99% by weight of the total amount N-desmethylzopiclone.  
   
   
       28 . The method of  claim 26  wherein the amount of (−)-N-desmethylzopiclone, or a pharmaceutically acceptable salt thereof, is greater than about 99% by weight of the total amount N-desmethylzopiclone.  
   
   
       29 . The method of  claim 8 , wherein the patient is human.  
   
   
       30 . The method of  claim 8 , wherein the therapeutically or prophylactically effective amount of N-desmethylzopiclone, or a pharmaceutically acceptable salt, solvate, hydrate, or clathrate thereof, is from about 0.1 mg to about 500 mg.  
   
   
       31 . The method of  claim 30  wherein the therapeutically or prophylactically effective amount of N-desmethylzopiclone, or a pharmaceutically acceptable salt, solvate, hydrate, or clathrate thereof is from about 0.5 mg to about 250 mg.  
   
   
       32 . The method of  claim 31  wherein the therapeutically or prophylactically effective amount of N-desmethylzopiclone, or a pharmaceutically acceptable salt, solvate, hydrate, or clathrate thereof, is from about 0.1 mg to about 500 mg.  
   
   
       33 - 68 . (canceled)