Compositions and method for treating affective, painful or allergic disorders

Abstract

Therapeutic compositions of doxepin having a preponderance of the cis doxepin isomer over the trans doxepin isomer provide therapeutic effects for affective, painful, or allergic disorders without the substantial sedative effects commonly experienced with compositions having a preponderance of the trans doxepin isomer.

1 . A composition comprising a preponderance of cis doxepin isomer over trans doxepin isomer, said cis doxepin isomer being present in an amount of about 0.01% to about 10.0% by weight, and a pharmaceutically acceptable vehicle, said composition for use in the treatment of affective, painful, allergic disorders, said composition being comparable in efficacy to compositions containing a preponderance of the trans doxepin isomer but with significantly less sedative effects.  
     
     
         2 . The composition of  claim 1  wherein said composition is suitable for application to the skin.  
     
     
         3 . The composition of  claim 2  wherein said vehicle is selected from the group consisting of a lotion, a solution, a cream, an ointment, a gel, or a paste.  
     
     
         4 . The composition of  claim 1  wherein said composition is suitable for application to mucous membranes.  
     
     
         5 . The composition of  claim 4  wherein said vehicle is selected from the group consisting of solutions, suspensions, suppositories, and plasticized formulations.  
     
     
         6 . The composition of  claim 1  wherein said composition is suitable for injection.  
     
     
         7 . The composition of  claim 1  wherein said cis doxepin isomer is present in the amount of about 0.05% to about 5.0% by weight.  
     
     
         8 . A method of treating affective, painful or allergic disorders comprising treatment with an effective amount of a composition containing a preponderance of cis doxepin isomer over trans doxepin isomer, said cis doxepin isomer being present in an amount of about 0.01% to about 10.0% by weight in a pharmaceutically acceptable vehicle, said composition being comparable in efficacy to compositions containing a preponderance of the trans doxepin isomer but with significantly less sedation.  
     
     
         9 . The method of  claim 8  wherein said method of treatment is selected from the group consisting of application to skin, application to mucous membranes and injection.  
     
     
         10 . The method of  claim 8  wherein said cis doxepin isomer is present in the amount of about 0.05-5.0% by weight.  
     
     
         11 . A composition suitable for oral administration comprising a pharmaceutically acceptable vehicle in the form of capsules, tablets, liquid solutions or suspensions and containing a preponderance of cis doxepin isomer over trans doxepin isomer, said cis doxepin isomer present in an amount of about 0.5-500.0 mg per capsule, tablet or 5 ml portion of liquid, said composition being comparable in efficacy to compositions containing a preponderance of the trans doxepin isomer but with significantly less sedative side effects.  
     
     
         12 . The composition of  claim 11  wherein said cis doxepin isomer is present in the amount of about 1.0-50.0 mg per capsule, tablet, or 5 ml portion of liquid.  
     
     
         13 . A method of treating affective, painful, or allergic disorders by oral administration and comprising treatment with an effective amount of a composition containing a preponderance of cis doxepin isomer over trans doxepin isomer, said cis doxepin isomer being present in an amount of about 0.5-500.0 per dose or 5 ml portion of liquid in a pharmaceutically acceptable vehicle, said composition being comparable in efficacy to compositions containing a preponderance of trans doxepin isomer but with significantly less sedative side effects.  
     
     
         14 . The method of  claim 13  wherein said cis doxepin isomer is present in the amount of about 1.0-50.0 mg per dose.