Combinations of Eszopiclone and Trans 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-N-Methyl-1-Napthalenamine or Trans 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-1-Napthalenamine, and Methods of Treatment of Menopause and Mood, Anxiety, and Cognitive Disorders

Abstract

One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., menopause, mood disorders, anxiety disorders, or cognitive disorders. The first component of the pharmaceutical composition is a sedative eszopiclone. The second component of the pharmaceutical composition is trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine or trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine. The present invention also relates to a method of treating menopause, perimenopause, mood disorders, anxiety disorders, and cognitive disorders.

1 . A pharmaceutical composition comprising eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         2 . A pharmaceutical composition comprising eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         3 . A method of treating a patient suffering from a menopause or perimenopause, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         4 . A method of treating a patient suffering from a menopause or perimenopause, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         5 . A method of treating a patient suffering from a mood disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         6 . A method of treating a patient suffering from a mood disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         7 . A method of treating a patient suffering from an anxiety disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         8 . A method of treating a patient suffering from an anxiety disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         9 . A method of treating a patient suffering from a cognitive disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. 
     
     
         10 . A method of treating a patient suffering from a cognitive disorder, comprising the step of co-administering to a patient in need thereof a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, clathrate, polymorph, or co-crystal thereof, and a therapeutically effective amount of trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine, or a pharmaceutically acceptable salt, clathrate, polymorph, or co-crystal thereof. 
     
     
         11 . The method according to  claim 5  or  6 , wherein the mood disorder is selected from major depression, major depressive disorder, mild depression, severe depression without psychosis, severe depression with psychosis, melancholia, atypical depression, dysthymic disorder, manic depression, bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar III disorder, cyclothymic disorder, chronic hypomania, premenstrual syndrome, premenstrual dysphoric disorder, prenatal depression, and postpartum depression. 
     
     
         12 . The method according to  claim 7  or  8 , wherein the anxiety disorder is selected from panic attacks, panic disorder, phobic disorders, obsessive-compulsive disorder, posttraumatic stress disorder, acute stress disorder, and generalized Anxiety Disorder. 
     
     
         13 . The method according to  claim 9  or  10 , wherein the cognitive disorder is selected from delirium, dementia, Alzheimer's Disease, Lewy body dementia, vascular dementia, Binswanger's dementia, Parkinson's disease, progressive supranuclear palsy, Huntington's disease, Pick's disease, Klüver-Bucy syndrome, frontal lobe dementia syndromes, normal-pressure hydrocephalus, subdural hematoma, Creutzfeldt-Jakob disease, Gerstmann-Sträussler-Scheinker disease, general paresis, AIDS dementia, decreased cognitive function and memory loss. 
     
     
         14 .- 25 . (canceled)