Time release sleep aid system

The composition of any one of the preceding claims, wherein the composition includes at least two sleep promoting active agents selected from the group consisting of melatonin, lactium, L-tryptophan, γ-aminobutyric acid, and magnesium.

The composition of any one of the preceding claims, wherein the composition includes at least two sleep quality active agents selected from the group consisting of an extract from Valeriana officinalis (root), an extract from Melissa officinalis, an extract from Phellodendron amurense, and an extract from Humulus lupus.

The composition of any one of the preceding claims, wherein the one or more sleep recovery active agents are selected from the group consisting of L-theanine, L-taurine, γ-aminobutyric acid, glycine, folic acid, (6S)-5-methyltetrahydrofolic acid or a salt thereof, inositol, riboflavin 5′-phosphate or a salt thereof, vitamin A, vitamin B12, methylcobalamin, cyanocobalamin, vitamin B3, vitamin B5, vitamin B6, pyridoxal 5′-phosphate, pyridoxine, vitamin B9, vitamin C, vitamin D3, a xanthine, carnosin, alpha-glycerylphosphoryl choline, lecithin, cytidine diphosphate choline, phosphatidyl serine, ATP, ribose, magnesium, coenzyme Q10, extract from Coleus forskohlii, extract from Bacopa monnieri, caffeine, ephedra, vincamine, chocamine, extract from cocoa extract, extract from Ginkgo biloba (leaf), Panax ginseng, extract from Eleutherococcus senticosus, extract from Centella asiatica, peppermint extract, rosemary extract, wild oats extract, blends thereof, and combinations thereof.

The composition of any one of the preceding claims, wherein the composition includes at least two sleep recovery active agents selected from the group consisting of an extract from cocao, L-theanine, vitamin B5, vitamin B6, vitamin B12, and folic acid, preferably at least one of vitamin B5, vitamin B6, or vitamin B12 and at least one of an extract from cocao, L-theanine, or folic acid.

The composition of any one of the preceding claims, further comprising one or more next day active agents to promote the maintenance of normal circadian rhythms, provide a nutrient for the production of endogenous sleep promoting active agents, and combinations thereof.

The composition of any one of the preceding claims, wherein the one or more next day active agents are selected from the group consisting of folic acid, (6S)-5-methyltetrahydrofolic acid or a salt thereof, inositol, riboflavin 5′-phosphate or a salt thereof, vitamin A, vitamin B12, cyanocobalamin, methylcobalamin, vitamin B3, vitamin B5, vitamin B6, pyridoxine, vitamin B9, vitamin C, vitamin D3, alpha-glycerylphosphoryl choline, lecithin, cytidine diphosphate-choline, phosphatidyl serine, ATP, Coleus Forskohlii extract, glycine, ribose, magnesium, coenzyme Q10, and combinations thereof.

The composition of any one of the preceding claims, wherein at least about 90% of the sleep promoting active agent is released within about 30 minutes, preferably within 15 minutes of administration.

The composition of any one of the preceding claims, wherein at least about 90% of the sleep quality active agent is released within about 6 hours of administration.

The composition of any one of the preceding claims, wherein the sleep quality active agent has a sustained release of from 1-6 hours, preferably from 2-5 hours, more preferably from 2.5-4.5 hours.

The composition of any one of the preceding claims, wherein the one or more sleep recovery active agents are released after about 3 hours of administration.

The composition of any one of the preceding claims, wherein the one or more sleep recovery active agent are released after about 5-7 hours, preferably after about 6-8.5 hours, more preferably after about 6.5-8.5 hours of administration.

The composition of any one of the preceding claims, further comprising a polymeric binder.

The composition of any one of the preceding claims, wherein the polymeric binder is selected from the group consisting of methyl cellulose, ethyl cellulose, microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate, cellulose, hypromellose, hydroxypropyl methylcellulose, carboxymethylcellulose, alkali metal carboxymethyl cellulose, carboxyethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, xanthan gum, viscarin, gelatin, starch, glucose, sucrose, polyvinyl pyrollidone, polyvinyl alcohol, gum tragacanth, gum karaya, and sodium alginate, Laponite CP or SP, magnesium aluminum silicate gel, and combinations thereof.

The composition of any one of the preceding claims, wherein the one or more sleep promoting active agents are encapsulated by a taste masking agent.

The composition of any one of the preceding claims, wherein the one or more sleep quality active agents are encapsulated by the polymeric binder.

The composition of any one of the preceding claims, wherein the one or more sleep recovery active agents are encapsulated by the polymeric binder.

The composition of any one of the preceding claims, wherein the one or more sleep quality active agents are in an amount of from about 0.5 wt % to about 55 wt %, based on the combined weight of the sleep quality active agents and the polymeric binder.

The composition of any one of the preceding claims, wherein the one or more sleep recovery active agents are in an amount of from about 0.5 wt % to about 55 wt %, based on the combined weight of the sleep recovery active agents and the polymeric binder.

The composition of any one of the preceding claims, wherein the composition is dispersed in a comestible matrix.

The composition of any one of the preceding claims, wherein the comestible matrix is selected from the group consisting of a solid, a semi-solid, a solution, a suspension, and an emulsion.

The composition of any one of the preceding claims, wherein the comestible matrix is selected from the group consisting of chocolate, chewing gum, lozenge, soft candy, soft chew, snack bar, a capsule, tablet, powder, and a drinkable preparation.

A composition comprising one or more sleep quality active agents and one or more next day active agents to promote the maintenance of normal circadian rhythms, provide a nutrient for the production of endogenous sleep promoting active agents, and combinations thereof, wherein upon administration to a subject there is

• sustained release of the one or more sleep quality active agents, and
• delayed release of the one or more next day active agents, and
• wherein each active agent is independently a phytochemical, a herbal extract, a vitamin, a hormone, an amino acid, a mineral, and combinations thereof.

A composition comprising one or more sleep recovery active agents and one or more next day active agents to promote the maintenance of normal circadian rhythms, provide a nutrient for the production of endogenous sleep promoting active agents, and combinations thereof, wherein upon administration to a subject there is

• delayed release of the one or more sleep recovery active agents, and
• delayed release of the one or more next day active agents, and
• wherein each active agent is independently a phytochemical, a herbal extract, a vitamin, a hormone, an amino acid, a mineral, and combinations thereof.

The composition of any one of the preceding claims, wherein the composition is in the form of a multilayered particle.

The composition of any one of the preceding claims, wherein the multilayered particle comprises two or three layers.

The composition of any one of the preceding claims, wherein the multilayered particle comprises the sleep quality active agents, the sleep recovery active agents, the sleep promoting active agents, or combinations thereof.

The composition of any one of the preceding claims, wherein the multilayered particle further comprises the next day active agents.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep promoting active agents that upon administration provides an immediate burst release of the sleep promoting active agents within about 30 minutes of administration,
• b. one or more sleep quality active agents that upon administration provides a delayed burst or delayed sustained release of the sleep quality active agents within about 6 hours of administration, and
• c. one or more sleep recovery active agents and optionally a next day active agent that upon administration provides a delayed burst or delayed sustained release of the sleep recovery active agents and the optional next day active agent after about 3 hours of administration.

The method of any one of the preceding claims, wherein the sleep disorder includes insomnia, narcolepsy, sleep apnea, hypersomnia, and combinations thereof.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep promoting active agents that upon administration provides an immediate burst release of the sleep promoting active agents within about 30 minutes of administration, and
• b. one or more sleep quality active agents that upon administration provides a delayed burst or delayed sustained release of the sleep quality active agents within about 6 hours of administration, and
• c. optionally a next day active agent that upon administration provides a delayed burst or delayed sustained release of the optional next day active agent after about 3 hours of administration.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep promoting active agents that upon administration provides an immediate burst release of the sleep promoting active agents within about 30 minutes of administration,
• b. optionally one or more sleep recovery active agents that upon administration provides a delayed burst or delayed sustained release of the sleep recovery active agents after about 3 hours of administration, and
• c. one or more next day active agent that upon administration provides a delayed burst or delayed sustained release of the next day active agent after about 3 hours of administration.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep quality active agents that upon administration provides a delayed burst or delayed sustained release of the sleep quality active agents within about 6 hours of administration, and
• b. one or more sleep recovery active agents that upon administration provides a delayed burst or delayed sustained release of the sleep recovery active agents after about 3 hours of administration, and
• c. optionally one or more next day active agent that upon administration provides a delayed burst or delayed sustained release of the next day active agent after about 3 hours of administration.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep quality active agents that upon administration provides a delayed burst or delayed sustained release of the sleep quality active agents within about 6 hours of administration, and
• b. optionally one or more sleep recovery active agents that upon administration provides a delayed burst or delayed sustained release of the sleep recovery active agents after about 3 hours of administration, and
• c. one or more next day active agent that upon administration provides a delayed burst or delayed sustained release of the next day active agent after about 3 hours of administration.

A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering:

• a. one or more sleep recovery active agents that upon administration provides a delayed burst or delayed sustained release of the sleep recovery active agents after about 3 hours of administration, and
• b. one or more next day active agent that upon administration provides a delayed burst or delayed sustained release of the next day active agent after about 3 hours of administration.