Methods for treating agitation using dexmedetomidine hydrochloride

A method for treating agitation or signs of agitation in a human subject who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject to a total dose in a range from about 2 mcg to about 100 mcg to achieve the desired anti-agitation effect.

The method according to any preceding claim, wherein the agitation or signs of agitation are associated with senile dementia of the Alzheimer's type (SDAT), Alzheimer's disease, schizophrenia, opioid withdrawal disorder, bipolar disorder, or hyperactive delirium.

The method according to any preceding claim, wherein the desired anti-agitation effect is achieved without also producing clinically meaningful effects on blood pressure and/or heart rate.

The method according to any preceding claim, wherein dexmedetomidine hydrochloride is administered intravenously as one or more discrete injections.

The method according to any preceding claim, wherein the subject is between 55 to 75 years old.

The method according to any preceding claim, wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale.

The method according to any preceding claim, wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from senile dementia of the Alzheimer's type (SDAT) who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a cumulative dose of about 0.15 mcg/kg to about 0.75 mcg/kg to achieve the desired anti-agitation effect, which effect persists for up to about 30 minutes after discontinuation of administration of dexmedetomidine hydrochloride, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from senile dementia of the Alzheimer's type (SDAT) who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 5 mcg to about 40 mcg to achieve the desired anti-agitation effect, which effect persists for up to about 30 minutes after discontinuation of administration of dexmedetomidine hydrochloride, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from schizophrenia who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 5 mcg to about 40 mcg to achieve the desired anti-agitation effect, wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from opioid withdrawal disorder who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 3 mcg to about 90 mcg to achieve at least a 50% reduction in COW score.

A method of treating agitation or signs of agitation in a human subject suffering from senile dementia of the Alzheimer's type (SDAT) who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.5 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 400 pg/ml, together with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from schizophrenia who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.5 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 400 pg/ml, wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

A method of treating agitation or signs of agitation in a human subject suffering from opioid withdrawal disorder who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.7 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 410 pg/ml, and at least a 50% reduction in COW score.