Composition and method for treating metabolic disorders
Bromocriptine citrate administered to a vertebrate, animal or human, can be used for any purpose including, e.g., the long-term modification and regulation of metabolic disorders, including prediabetes, obesity, insulin resistance, hyperinsulinemia, hyperglycemia and type 2 diabetes mellitus (T2DM) and/or, e.g., the treatment of other medical disorder(s) including immune or endocrine disorders or diseases. Bromocriptine citrate is administered over a limited or extended period at a time of day dependent on re-establishing the normal circadian rhythm of central dopaminergic activity of healthy members of a similar species and sex. Insulin resistance, hyperinsulinemia and hyperglycemia, T2DM, prediabetes, MS or all, can be controlled in humans on a long term basis by such treatment inasmuch as the daily administration of bromocriptine citrate resets neuronal activity timing in the neural centers of the brain to produce long term effects.
1 . The method of treating obesity which comprises administering to a subject in need of such treatment a pharmaceutical composition comprising an effective amount for treating the obesity of bromocriptine citrate.
2 . The method of claim 1 wherein the effective amount is between 0.05 μg and 0.5 mg/kg of body weight per day.
3 . The method of claim 1 which comprises administering the pharmaceutical composition at a time of day that will increase central dopaminergic activity of the subject at the time of day of the circadian peak of central dopaminergic activity in a healthy individual of the same species and sex.
4 . The method of claim 3 which comprises administering the pharmaceutical composition between 0400 and 1200 hours of the day.
5 . The method of claim 1 wherein the pharmaceutical composition comprises a tablet.
6 . The method of claim 5 wherein the tablet comprises a sublingual tablet.
7 . The method of claim 1 which comprises administering the pharmaceutical composition via the sublingual route.
8 . The method of claim 3 which comprises administering the pharmaceutical composition within two hours after awakening.
9 . The method of claim 3 which comprises administering the pharmaceutical composition between 4 hours before and four hours after the onset of daily locomotor activity.
10 . The method of claim 3 which comprises administering the pharmaceutical composition between two hours before and two hours after the onset of daily locomotor activity.
11 . The method of claim 1 which comprises administering the pharmaceutical composition in an oral dosage form.
12 . The method of claim 1 which comprises parenterally administering the bromocriptine citrate.
13 . The method of claim 1 which comprises co-administering at least one of an alpha-I adrenergic antagonist, an alpha 2 adrenergic agonist, a serotonergic inhibitor or a serotonin 5HT1b agonist with the bromocriptine citrate.
14 . The method of claim 1 which comprises administering the pharmaceutical composition via the sublingual route.