Compositions and Methods for Sleep Regulation

Abstract

Compositions and methods for the regulation of sleep and circadian rhythms are provided. The compositions are nutritional supplements containing melatonin and one or more vitamins that enhance the effectiveness of melatonin. Preferred vitamins include folic acid, riboflavin (vitamin B 2 ), cobalamin (vitamin B 12 ) or pyridoxine (vitamin B 6 ). The compositions beneficially and advantageously regulate sleep when administered to an individual and are administered to a human or animal suffering from an irregular sleep or circadian rhythm or are administered in anticipation of the development of such an irregularity.

1 . A composition for regulating sleep or circadian rhythms in a human or an animal, comprising melatonin, folic acid, riboflavin, cobalamin, and pyridoxine. 
     
     
         2 . The composition of  claim 1 , comprising less than approximately 5 mg of melatonin per unit dosage form. 
     
     
         3 . The composition of  claim 1 , comprising between approximately 0.001 mg to approximately 3 mg of cobalamin per unit dosage form. 
     
     
         4 . The composition of  claim 2 , comprising between approximately 2 mg to approximately 3 mg of cobalamin per unit dosage form. 
     
     
         5 . The composition of  claim 1 , comprising between approximately 15 mg to approximately 35 mg of pyridoxine per unit dosage form. 
     
     
         6 . The composition of  claim 1 , comprising between approximately 0.4 mg to approximately 10 mg of folic acid per unit dosage form. 
     
     
         7 . The composition of  claim 1 , comprising between approximately 100 mg to approximately 200 mg of riboflavin per unit dosage form. 
     
     
         8 . The composition of  claim 1 , comprising approximately 3 mg of melatonin per unit dosage form. 
     
     
         9 . The composition of  claim 1 , comprising approximately 1 mg of melatonin per unit dosage form. 
     
     
         10 . The composition of  claim 1 , comprising approximately 3 mg of melatonin, approximately 2.5 mg of folic acid, approximately 150 mg of riboflavin, approximately 2.5 of cobalamin and approximately 25 mg pyridoxine per unit dosage form. 
     
     
         11 . The composition of  claim 1 , further comprising an inactive ingredient, wherein the inactive ingredient is inulin, crospovidone, magnesium stearate, hypromellose or combinations thereof. 
     
     
         12 . The composition of  claim 1 , wherein the composition is a rapid release composition, a delayed release composition, or a combination thereof. 
     
     
         13 . The composition of  claim 1 , further comprising a coating. 
     
     
         14 . The composition of  claim 13 , wherein the coating comprises cellulose, beta-carotene, or a combination thereof. 
     
     
         15 . A method for regulating sleep or circadian rhythms in a human or animal comprising administering to the human or animal a nutritional composition comprising melatonin, cobalamin, and a vitamin, wherein the vitamin is folic acid, riboflavin, or pyridoxine. 
     
     
         16 . The method of  claim 15 , wherein the composition comprises less than approximately 5 mg of melatonin per unit dosage form. 
     
     
         17 . The method of  claim 15 , wherein the composition comprises between approximately 0.001 mg to approximately 3 mg of cobalamin per unit dosage form. 
     
     
         18 . The method of  claim 15 , wherein the composition comprises between approximately 2 mg to approximately 3 mg of cobalamin per unit dosage form. 
     
     
         19 . The method of  claim 15 , wherein the composition comprises between approximately 15 mg to approximately 35 mg of pyridoxine per unit dosage form. 
     
     
         20 . The method of  claim 15 , wherein the composition comprises between approximately 0.4 mg to approximately 10 mg of folic acid per unit dosage form. 
     
     
         21 . The method of  claim 15 , wherein the composition comprises between approximately 100 mg to approximately 200 mg of riboflavin per unit dosage form. 
     
     
         22 . The method of  claim 15 , wherein the composition comprises-approximately 3 mg of melatonin, approximately 2.5 mg of folic acid, approximately 150 mg of riboflavin, approximately 2.5 mg of cobalamin and approximately 25 mg pyridoxine per unit dosage form. 
     
     
         23 . The method of  claim 15 , wherein regulating sleep is inducing sleep or maintaining sleep. 
     
     
         24 . A method of regulating a biological response of a human or an animal to melatonin comprising administering to the human or animal a composition comprising melatonin, cobalamin and a vitamin, wherein the vitamin is folic acid, riboflavin, or pyridoxine. 
     
     
         25 . The method of  claim 24 , wherein the biological response is the induction of sleep or an ability to remain asleep.