Neuroactive steroids, compositions, and uses thereof

Abstract

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).

We claim: 
     
         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.