Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine

Abstract

The present invention relates to methods tor the treatment or prevention of fatigue associated with disordered sleep, for example, in multiple sclerosis, fibromyalgia, Fabry's disease, Parkinson's disease, or traumatic brain injury, using cyclobenzaprine. The present invention further relates to a biomarker for the therapeutic effects of a cyclobenzaprine treatment.

1 - 7 . (canceled) 
     
     
         8 . A method for treating muscle spasticity associated with multiple sclerosis or traumatic brain injury, comprising administering to a human in need of such treatment a pharmaceutical composition comprising cyclobenzaprine in a therapeutically effective amount and a therapeutically effective carrier, wherein such treatment ameliorates or eliminates the muscle spasticity. 
     
     
         9 - 10 . (canceled) 
     
     
         11 . The method of  claim 8 , wherein the pharmaceutical composition is administered as an orally dissolving tablet, as a thin film formulation, or as a promicellar formulation. 
     
     
         12 - 19 . (canceled) 
     
     
         20 . The method of  claim 8 , wherein the amount of cyclobenzaprine administered is between 5 mg/day and 12 mg/day. 
     
     
         21 . The method of  claim 8 , wherein the amount of cyclobenzaprine administered is less than 5 mg/day. 
     
     
         22 . The method of  claim 8 , wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day.