Compositions and methods for treating middle-of-the night insomnia

Abstract

The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

1 . A method of treating MOTN insomnia in a subject, comprising the steps of: 
 administering a solid pharmaceutical composition comprising an effective sleep-inducing amount of zolpidem or a salt thereof representing less than 1.30×10 −5  moles of zolpidem to a subject who awakens from sleep and desires to resume sleep for less than 5 hours,    wherein the step of administering the solid pharmaceutical composition is performed after the subject awakens from sleep,    wherein the composition provides delivery of zolpidem across the subject's oral mucosa,    wherein the solid pharmaceutical composition dissolves or disintegrates in about 10 minutes or less in the subject's mouth, and    wherein said amount permits the subject to awaken at a time about four hours after dosing without residual sedative effects.    
     
     
         2 . The method of  claim 1 , wherein the solid pharmaceutical composition further comprises a binder and a disintegrating agent.  
     
     
         3 . The method of  claim 1 , wherein the solid pharmaceutical composition is administered sublingually.  
     
     
         4 . The method of  claim 1 , wherein the oral mucosa is selected from the group consisting of sublingual mucosa, buccal mucosa, gingival mucosa, palatal mucosa, and lining of the lips.  
     
     
         5 . The method of  claim 1 , wherein a mean peak plasma concentration of zolpidem between about 20 to about 100 ng/ml is produced within about 30 minutes.  
     
     
         6 . The method of  claim 1 , wherein a therapeutically effective amount of zolpidem enters the bloodstream within about 30 minutes.  
     
     
         7 . The method of  claim 1 , wherein the solid pharmaceutical composition is a lozenge.  
     
     
         8 . The method of  claim 1 , wherein the solid pharmaceutical composition is a tablet.  
     
     
         9 . The method of  claim 1 , wherein the carbonate buffer and bicarbonate buffer raise the pH of a subject's saliva to a pH greater than 7.8.