NON-SEDATING DEXMEDETOMIDINE TREATMENT REGIMENS
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
1 . A method of treating agitation associated with dementia of a human subject in need thereof using an oromucosal formulation of dexmedetomidine, comprising:
administering the oromucosal formulation comprising an effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof to the human subject;
wherein the human subject has a corrected QT interval using Fridericia's correction method (QTcF) of no greater than 450 msec for males and no greater than 470 msec for females; and
wherein the effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof, is about 60 micrograms of dexmedetomidine.
2 . The method of claim 1 , wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride.
3 . The method of claim 1 , wherein the treatment comprises a decrease in the agitation that is statistically significant at about 30 minutes following the administration.
4 . The method of claim 1 , wherein the treatment comprises a decrease in the agitation that is statistically significant at about 20 minutes following the administration.
5 . The method of claim 1 , wherein the oromucosal formulation is an oromucosal film.
6 . The method of claim 5 , wherein the oromucosal formulation is administered sublingually.
7 . The method of claim 5 , wherein the oromucosal formulation is administered buccally.
8 . The method of claim 1 , wherein the oromucosal formulation is an oromucosal tablet.
9 . The method of claim 8 , wherein the oromucosal formulation is administered sublingually.
10 . The method of claim 8 , wherein the oromucosal formulation is administered buccally.
11 . The method of claim 1 , wherein the oromucosal formulation is an oromucosal wafer.
12 . The method of claim 11 , wherein the oromucosal formulation is administered sublingually.
13 . The method of claim 11 , wherein the oromucosal formulation is administered buccally.
14 . The method of claim 1 , wherein the human subject does not have an advanced heart block.