US2011319389A1PendingUtilityA1

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

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Assignee: LEDERMAN SETHPriority: Jun 24, 2010Filed: Jun 9, 2011Published: Dec 29, 2011
Est. expiryJun 24, 2030(~3.9 yrs left)· nominal 20-yr term from priority
Inventors:Seth LedermanHerb Harris
A61P 25/16A61P 25/00A61K 9/28A61K 45/06G16C 99/00A61K 9/0053A61K 9/4825A61K 9/2059A61K 9/2866A61K 31/137A61K 9/2018A61K 31/135G16C 20/50
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Claims

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.

Claims

exact text as granted — not AI-modified
1 . A method for treating fatigue associated with disordered sleep 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 fatigue. 
     
     
         2 . The method of  claim 1 , wherein the amount of cyclobenzaprine administered is less than 5 mg/day. 
     
     
         3 . The method of  claim 2 , wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day. 
     
     
         4 . The method of  claim 1 , 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. 
     
     
         5 . The method of  claim 1 , wherein the fatigue associated with disordered sleep is a symptom of multiple sclerosis, a symptom of Fabry's disease, a symptom of traumatic brain injury, is a symptom of fibromyalgia, or a symptom of Parkinson's disease 
     
     
         6 . The method of  claim 1 , wherein the pharmaceutical composition is administered as an orally dissolving tablet, as a thin film formulation, or as a promicellar formulation. 
     
     
         7 . The method of  claim 1 , wherein the pharmaceutical composition is administered at bedtime. 
     
     
         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 . A method for monitoring the effectiveness of a cyclobenzaprine treatment for disordered sleep, the method comprising determining CAP A1, A2 and A3 rates, and calculating an nCAP A2+A3 (CAP A2+A3(Norm) ) value to determine whether a specified CAP A2+A3(Norm)  threshold is achieved, wherein when the specified CAP A2+A3(Norm)  threshold is achieved the cyclobenzaprine treatment is effective. 
     
     
         19 . The method of  claim 18 , wherein the specified CAP A2+A3(Norm)  threshold is ≦33%.

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