Use of sublingual dexmedetomidine for the treatment of agitation

Abstract

The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.

What is claimed is: 
     
         1 . A method of treating agitation in an agitated human subject, said agitated human subject having schizophrenia or bipolar disorder, comprising administering oromucosally to said agitated human subject a dissolvable film comprising an effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof, and wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered as a single dosage. 
     
     
         2 . The method of  claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered sublingually. 
     
     
         3 . The method of  claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered buccally. 
     
     
         4 . The method of  claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride. 
     
     
         5 . The method of  claim 1 , wherein said agitated human subject has schizophrenia. 
     
     
         6 . The method of  claim 1 , wherein said agitated human subject has bipolar disorder. 
     
     
         7 . The method of  claim 1 , wherein said single dosage is about 3 micrograms to about 100 micrograms. 
     
     
         8 . The method of  claim 7 , wherein said single dosage is about 5 micrograms to about 90 micrograms. 
     
     
         9 . The method of  claim 7 , wherein said single dosage is about 5 micrograms to about 80 micrograms. 
     
     
         10 . The method of  claim 7 , wherein said single dosage is about 5 micrograms to about 70 micrograms. 
     
     
         11 . The method of  claim 7 , wherein said single dosage is about 5 micrograms to about 60 micrograms. 
     
     
         12 . The method of  claim 7 , wherein said single dosage is about 5 micrograms to about 40 micrograms. 
     
     
         13 . The method of  claim 7 , wherein said single dosage is about 30 micrograms. 
     
     
         14 . The method of  claim 7 , wherein said single dosage is about 60 micrograms. 
     
     
         15 . The method of  claim 7 , wherein said single dosage is about 90 micrograms. 
     
     
         16 . The method of  claim 1 , wherein the agitation is acute agitation. 
     
     
         17 . The method of  claim 1 , wherein the agitation is chronic agitation.