AAntihistamines In Combination With A Range Of Substances For Improved Health

Abstract

The present invention provides for novel combinations comprising an antihistamine with selected pharmaceutical and nutraceutical agents which alleviate some of the symptoms experienced by menopausal women, optionally combined further with a range of indole-based natural products such as L-tryptophan, 5-hydroxytryptophan and melatonin. These mixtures may be enriched further with pharmaceutically acceptable calcium and magnesium salts as well as selected B vitamins. These combinations have utility in providing a medicament for improving health in mammals, especially for the improvement of menopausal symptoms as well as sleep in women.

1 - 9 . (canceled) 
     
     
         10 . A pharmaceutical composition for the treatment of sleep disorders and inducing restorative sleep function comprising a mixture of an antihistamine drug and at least two indole-based dietary supplements. 
     
     
         11 . A composition according to  claim 10  comprising: doxylamine or its pharmaceutically acceptable salts; L-tryptophan and melatonin or their pharmaceutically acceptable salts; a pharmaceutically acceptable calcium salt; a pharmaceutically acceptable magnesium salt; vitamin B.sub.3 or its pharmaceutically acceptable salts; and a pharmaceutically acceptable carrier. 
     
     
         12 . A composition according to  claim 11  wherein the doxylamine is present in its substantially pure single enantiomer form, or a pharmaceutically acceptable salt thereof. 
     
     
         13 . The composition in  claim 11  further including vitamin B6 or its pharmaceutically acceptable salts. 
     
     
         14 . The composition in  claim 13  further including amino acids from a group consisting of theanine, GABA, and combinations thereof. 
     
     
         15 . The composition in  claim 13  further including substances that ameliorate symptoms of the menopause. 
     
     
         16 . A composition according to  claim 11  wherein the melatonin is provided in a slow-release formulation. 
     
     
         17 . A method of treating a sleep disorder comprising administering a sleep-inducing amount of a composition comprising an antihistamine drug, at least one dietary supplement and substance(s) that have effect in the treatment of a range of symptoms related to the menopause. 
     
     
         18 . The method of claim  1  wherein the composition is in a form from a group consisting of a tablet, a fast dissolving tablet, capsule and beverage. 
     
     
         19 . A pharmaceutical composition for the treatment of sleep disorders and the induction of restorative sleep function comprising: A. At least one indole-based dietary supplement, and B. At least one substance with beneficial effect in the treatment of menopausal symptoms. 
     
     
         20 . A method of claim  1  wherein the sleep disorder is from a group consisting of occasional sleeplessness, acute insomnia, chronic insomnia, transient/temporary insomnia, inducing restorative sleep function, sleep-related breathing disorders, obstructive sleep apnea, non-restorative sleep, insomnia associated with jet lag disorder, sleep difficulties related to circadian rhythm steep disorders, sleep problems relating to shift work disorder, subjects experiencing difficulty falling asleep, subjects experiencing difficulty maintaining sleep, and combinations thereof. 
     
     
         21 . A pharmaceutical composition for the treatment of sleep disorders and the induction of restorative sleep function comprising: A. At least one antihistamine, and B. At least one substance with beneficial effect in the treatment of menopausal symptoms.