NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF
Described herein are methods of treating a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression; and anxiety disorder, the method comprising administering to a human subject suffering from a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression, an anxiety disorder with a neuroactive steroid or a composition comprising a neuroactive steroid (e.g., pregnanolone, allopregnanolone, alphadalone, ganaxolone, or alphaxolone).
1 - 65 . (canceled)
66 . A method for treating post-partum depression in a human subject in need thereof, the method comprising administering a sterile solution comprising 5 mg/mL allopregnanolone in 250 mg/mL sulfobutylether-β-cyclodextrin at a dosing regimen over a time period of about 60 hours, wherein the dosing regimen comprises a continuous infusion of the sterile solution as follows:
30 μg/kg/hour from about hour 0 to about hour 4;
60 μg/kg/hour from about hour 4 to about hour 24;
90 μg/kg/hour from about hour 24 to about hour 52;
60 μg/kg/hour from about hour 52 to about hour 56; and
30 μg/kg/hour from about hour 56 to about hour 60.
67 . The method of claim 66 , wherein the sterile solution is buffered with citrate.
68 . The method of claim 67 , wherein the sterile solution is diluted.
69 . The method of claim 68 , wherein the diluent comprises sterile water for injection.
70 . The method of claim 68 , wherein the diluent comprises sterile saline.
71 . The method of claim 68 , wherein the diluted sterile solution comprises 1 mg/mL allopregnanolone.
72 . The method of claim 66 , wherein sulfobutylether-β-cyclodextrin includes a sulfobutylether-β-cyclodextrin salt.
73 . The method of claim 66 , wherein sulfobutylether-β-cyclodextrin includes a sulfobutylether-β-cyclodextrin sodium salt.
74 . The method of claim 66 , wherein the infusion is an intravenous (IV) infusion.
75 . A method for treating post-partum depression in a human subject in need thereof, the method comprising diluting a sterile solution of 5 mg/mL allopregnanolone in 250 mg/mL sulfobutylether-β-cyclodextrin buffered with citrate with sterile water for injection to render it isotonic for IV infusion, wherein the diluted solution is administered at a dosing regimen over a time period of about 60 hours, wherein the dosing regimen comprises a continuous infusion of:
30 μg/kg/hour from about hour 0 to about hour 4;
60 μg/kg/hour from about hour 4 to about hour 24;
90 μg/kg/hour from about hour 24 to about hour 52;
60 μg/kg/hour from about hour 52 to about hour 56; and
30 μg/kg/hour from about hour 56 to about hour 60.
76 . The method of claim 75 , wherein the sterile solution is further diluted with sterile saline.
77 . The method of claim 75 , wherein the diluted sterile solution comprises 1 mg/mL allopregnanolone.
78 . The method of claim 75 , wherein sulfobutylether-β-cyclodextrin includes a sulfobutylether-β-cyclodextrin salt.
79 . The method of claim 75 , wherein sulfobutylether-β-cyclodextrin includes a sulfobutylether-β-cyclodextrin sodium salt.