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

Abstract

The present invention relates to methods for 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 . The method of  claim 8 , wherein the amount of cyclobenzaprine administered is less than 5 mg/day. 
     
     
         10 . The method of  claim 8 , wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day. 
     
     
         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 . A method for reducing CAP rates A2 or A3, 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 reduces CAP rates A2 or A3. 
     
     
         13 . The method of  claim 12 , wherein the amount of cyclobenzaprine administered is less than 5 mg/day. 
     
     
         14 . The method of  claim 12 , wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day. 
     
     
         15 . The method of  claim 12 , wherein the method further comprises administering sequentially or concurrently a drug selected from the group consisting of a dual reuptake inhibitor, a serotonin-norepinephrine reuptake inhibitor or a calcium channel inhibitor. 
     
     
         16 . The method of  claim 12 , wherein the pharmaceutical composition is administered as an orally dissolving tablet, as a thin film formulation, or as a promicellar formulation. 
     
     
         17 . The method of  claim 12 , wherein the pharmaceutical composition is administered at bedtime. 
     
     
         18 .- 19 . (canceled)