Compositions including modafinil for treatment of eating disorders and for appetite stimulation

Abstract

Modafinil is effective in improving symptoms of eating disorders or in stimulating appetite.

What is claimed is:  
     
         1 . A method of treating an eating disorder in a mammal comprising administering to said mammal an amount of a modafinil compound effective to stimulate the appetite of said mammal.  
     
     
         2 . A method of promoting weight gain in a mammal comprising administering to said mammal an amount of a modafinil compound effective to stimulate the appetite of said mammal.  
     
     
         3 . A method of increasing appetite in a mammal comprising administering to said mammal an amount of a modafinil compound effective to increase the appetite of said mammal.  
     
     
         4 . A method of treating a mammal suffering from the symptoms of an eating disorder comprising administering to said mammal a pharmaceutical composition comprising a modafinil compound in an amount effective to stimulate orexin activity in the central nervous system of said mammal.  
     
     
         5 . The method of any of claims  1 - 4 , wherein said modafinil compound is modafinil.  
     
     
         6 . The method of any of claims  1 - 4 , wherein said mammal is a human.  
     
     
         7 . The method of  claim 2  or  3 , wherein said mammal is a domesticated animal useful for producing meat.  
     
     
         8 . The method of  claim 7 , wherein said mammal is a bovine, ovine, caprine, or porcine animal.  
     
     
         9 . The method of any of claims  1 - 4 , wherein said mammal is human suffering from, or susceptible to an eating disorder or to wasting associated with a disease.  
     
     
         10 . The method of  claim 9 , wherein said eating disorder is anorexia nervosa.  
     
     
         11 . The method of any of claims  1 - 4 , wherein said effective amount is from about 1 to about 400 mg per daily dose.  
     
     
         12 . The method of any of claims  1 - 4 , wherein said effective amount is from about 100 to about 400 mg per daily dose.  
     
     
         13 . The method of any of claims  1 - 4 , wherein said effective amount is about 200 mg per daily dose.  
     
     
         14 . The method of any of claims  1 - 4 , wherein said effective amount is an amount that is effective to achieve a serum level of modafinil of from about 0.05 to about 20 g/ml in said mammal.  
     
     
         15 . The method of any of claims  1 - 4 , wherein said effective amount is an amount that is effective to achieve a serum level of modafinil of from about 1 to about 20 :g/ml in said mammal.  
     
     
         16 . The method of any of claims  1 - 4 , wherein said modafinil compound is formulated for oral administration.  
     
     
         17 . The method of any of claims  1 - 4 , wherein said modafinil compound is formulated as a tablet.  
     
     
         18 . The method of  claim 17 , wherein said tablet contains lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, or talc in any combination.  
     
     
         19 . The method of any of claims  1 - 4 , wherein said modafinil compound is incorporated into a food product or a liquid.  
     
     
         20 . A pharmaceutical composition in unit dose form, for use in treating an eating disorder in a subject susceptible to the development of or suffering from an eating disorder, which comprises: 
 an amount of a modafinil compound such that one or more unit doses thereof are effective to stabilize or improve the symptoms of an eating disorder in said subject upon periodic administration.    
     
     
         21 . A veterinary composition in unit dose form, for use in increasing appetite in an animal, which comprises: 
 an amount of a modafinil compound such that one or more unit doses thereof are effective to increase the appetite of an animal upon periodic administration.    
     
     
         22 . The composition of  claim 21  wherein said animal is a weanling.  
     
     
         23 . The composition of  claim 20  or  21 , wherein said modafinil compound is modafinil.  
     
     
         24 . The composition of  claim 20 , wherein said subject or said mammal is a human.  
     
     
         25 . The composition of  claim 21 , wherein said mammal is a domesticated animal useful for producing meat.  
     
     
         26 . The composition of  claim 25 , wherein said mammal is a bovine, ovine, caprine, or porcine animal.  
     
     
         27 . The composition of  claim 20 , wherein said subject or said mammal is a human suffering from, or susceptible to an eating disorder or to wasting associated with a disease.  
     
     
         28 . The composition of  claim 27 , wherein said eating disorder is anorexia nervosa.  
     
     
         29 . The composition of  claim 20 , wherein said effective amount is from about 1 to about 400 mg per daily dose.  
     
     
         30 . The composition of  claim 20 , wherein said effective amount is from about 100 to about 400 mg per daily dose.  
     
     
         31 . The composition of  claim 20 , wherein said effective amount is about 200 mg per daily dose.  
     
     
         32 . The composition of  claim 20 , wherein said effective amount is an amount that is effective to achieve a serum level of modafinil of from about 0.05 to about 20 :g/ml in said subject.  
     
     
         33 . The composition of  claim 20 , wherein said effective amount is an amount that is effective to achieve a serum level of modafinil of from about 1 to about 20 :g/ml in said subject.  
     
     
         34 . The composition of  claim 20  or  21 , wherein said composition comprising a modafinil compound is formulated for oral administration.  
     
     
         35 . The composition of  claim 20  or  21 , wherein said composition comprising a modafinil compound is formulated as a tablet.  
     
     
         36 . The composition of  claim 35 , wherein said tablet contains lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, or talc in any combination.  
     
     
         37 . The composition of  claim 20  or  21 , wherein said modafinil compound is incorporated into a food product or a liquid.  
     
     
         38 . A therapeutic package for dispensing to, or for use in dispensing to, a mammal being treated for an eating disorder, comprising: 
 (1) one or more unit doses, each such unit dose containing an amount of a modafinil compound such that said one or more unit doses thereof are effective to stabilize or improve a symptom of an eating disorder in said mammal upon periodic administration and the unit doses being administered periodically; and    (2) a finished pharmaceutical container therefor, said container containing said unit dose or unit doses and labeling directing the use of said package in the treatment of said mammal.    
     
     
         39 . The therapeutic package according to  claim 38 , wherein the unit dose is adapted for oral administration.  
     
     
         40 . The therapeutic package according to  claim 38 , wherein the amount of the modafinil compound contained in each unit dose provides a dose effective to achieve a serum level of modafinil in said mammal of from about 0.05 to about 20 :g/ml.  
     
     
         41 . The therapeutic package according to  claim 38 , wherein the amount of the modafinil compound contained in each unit dose provides a dose effective to achieve a serum level of modafinil in said mammal of from about 1 to about 20 :g/ml.  
     
     
         42 . The therapeutic package according to  claim 38 , wherein the amount of the modafinil compound contained in each unit dose provides a dose effective to achieve a serum level of modafinil in said mammal of from about 1 to about 10 :g/ml.  
     
     
         43 . The therapeutic package according to  claim 38 , wherein the amount of the modafinil compound contained in each unit dose provides a dose effective to achieve a serum level of modafinil in said mammal of from about 0.5 to about 1.5 :g/ml.  
     
     
         44 . The therapeutic package according to  claim 38 , wherein the unit dose comprises a tablet for oral administration.  
     
     
         45 . The therapeutic package according to  claim 38 , wherein said modafinil compound is modafinil.  
     
     
         46 . The therapeutic package according to  claim 38 , wherein said mammal has or is susceptible to anorexia nervosa.  
     
     
         47 . The therapeutic package according to  claim 44 , wherein said tablet comprises lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, or talc.  
     
     
         48 . The therapeutic package according to  claim 38 , wherein said mammal is a human.