USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION
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.
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.