Methods of treating circadian rhythm sleep disorders

Abstract

Methods of treating irregular sleep-wake rhythm disorder in subjects and compositions for use in the same are disclosed.

1 - 6 . (canceled) 
     
     
         7 . A method of improving continuity of nocturnal sleep in a subject with irregular sleep-wake rhythm disorder, with dementia due to Alzheimer's disease and/or related disorders, or with mild cognitive impairment due to Alzheimer's disease comprising administering to a subject in need thereof an effective amount of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing. 
     
     
         8 . A method of improving at least one behavior and/or cognitive difficulty chosen from behavior and cognitive difficulties associated with irregular sleep-wake rhythm disorder, behavior and cognitive difficulties associated with dementia due to Alzheimer's disease and/or related disorders, and behavior and cognitive difficulties associated with dementia in a subject with mild cognitive impairment due to Alzheimer's disease comprising administering to a subject in need thereof an effective amount of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing. 
     
     
         9 . A method of treating excessive daytime sleepiness and/or napping in a subject with irregular sleep-wake rhythm disorder, with dementia due to Alzheimer's disease and/or related disorders, or with mild cognitive impairment due to Alzheimer's disease comprising administering to a subject in need thereof an effective amount of a compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing. 
     
     
         10 . The method according to  claim 7 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates sleep during the nighttime hours. 
     
     
         11 . The method according to  claim 7 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates wakefulness during the daytime hours. 
     
     
         12 . The method according to  claim 7 , wherein the subject experiences an increase in sleep efficiency. 
     
     
         13 . The method according to  claim 7 , wherein the subject experiences a decrease in daytime sleepiness and/or daytime napping. 
     
     
         14 . The method according to  claim 7 , wherein the subject experiences an increase in daytime alertness. 
     
     
         15 . The method according to  claim 7 , wherein the administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, results in a stabilization or improvement of one or more circadian rhythms. 
     
     
         16 - 25 . (canceled) 
     
     
         26 . The method according to  claim 9 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates sleep during the nighttime hours. 
     
     
         27 . The method according to  claim 9 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates wakefulness during the daytime hours. 
     
     
         28 . The method according to  claim 9 , wherein the subject experiences an increase in sleep efficiency. 
     
     
         29 . The method according to  claim 9 , wherein the subject experiences a decrease in daytime sleepiness and/or daytime napping. 
     
     
         30 . The method according to  claim 9 , wherein the subject experiences an increase in wake efficiency. 
     
     
         31 . The method according to  claim 9 , wherein the subject experiences an increase in daytime alertness. 
     
     
         32 . The method according to  claim 8 , wherein the subject experiences a clinical stabilization in cognitive impairment due to Alzheimer's disease and/or related disorders. 
     
     
         33 . The method according to  claim 8 , wherein the subject experiences a clinical improvement in the cognitive impairment due to Alzheimer's disease and/or related disorders. 
     
     
         34 . The method according to  claim 8 , wherein the subject experiences a clinical reduction in rate of decline in the cognitive impairment due to Alzheimer's disease and/or related disorders. 
     
     
         35 . The method according to  claim 8 , wherein the subject experiences a clinical stabilization of the dementia due to Alzheimer's disease and/or related disorders. 
     
     
         36 . The method according to  claim 8 , wherein the subject experiences a clinical improvement of the dementia due to Alzheimer's disease and/or related disorders. 
     
     
         37 . The method according to  claim 8 , wherein the subject experiences a clinical reduction in rate of decline in dementia due to Alzheimer's disease and/or related disorders. 
     
     
         38 . The method according  claim 8 , wherein the subject experiences a decrease in behavioral disturbances. 
     
     
         39 . The method according to  claim 9 , wherein the subject experiences a reduction in the accumulation of Δβ plaque in the brain. 
     
     
         40 . The method according to  claim 9 , wherein the subject experiences a reduction of soluble toxic Δβ aggregates. 
     
     
         41 . A method of stabilizing and/or improving one or more circadian rhythms in a subject comprising administering to a subject in need thereof an effective amount of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing. 
     
     
         42 . (canceled) 
     
     
         43 . The method according to  claim 41 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates sleep during the nighttime hours. 
     
     
         44 . The method according to  claim 41 , wherein administration of the at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing, consolidates wakefulness during the daytime hours. 
     
     
         45 . The method according to  claim 41 , wherein the subject experiences an increase in sleep efficiency. 
     
     
         46 . The method according to  claim 41 , wherein the subject experiences a decrease in daytime sleepiness and/or daytime napping. 
     
     
         47 . The method according to  claim 41 , wherein the subject experiences an increase in daytime alertness. 
     
     
         48 . The method according to  claim 41 , wherein the subject experiences a stabilization or an improvement of one or more circadian rhythms.