# US 11,351,150 B2 · Time release sleep aid system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,351,150 B2 - Document ID: US11351150B2 - Status: Granted - Kind: B2 - Application number: 16/626,668 - Filed: 2018-06-27 - Published: 2020-05-07 - Granted: 2022-06-07 - Earliest claimed: 2017-06-27 - Assignees: NightWise, LLC - Applicants: NightWise, LLC - Inventors: Danny Rinaldi; Scott Forsberg - Web page: https://patentgrep.com/patent/US11351150B2 ## CPC - A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin - A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals} - A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205) - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin - A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675) - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate - A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12 - A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} - A61K 33/08: Oxides; Hydroxides - A61K 36/3486: {Humulus} - A61K 36/53: Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender - A61K 36/5777: {Theobroma, e.g. cocao or cocoa} - A61K 36/756: Phellodendron, e.g. corktree - A61K 36/84: Valerianaceae (Valerian family), e.g. valerian - A61K 38/018: {from milk} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/20: Hypnotics; Sedatives - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Compositions for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject are disclosed herein. In some examples, the composition can comprise one or more sleep promoting active agents, one or more sleep quality active agents, one or more sleep recovery active agents, and optionally one or more next day active agents. The composition can provide an immediate burst release of the one or more sleep promoting active agents, a delayed burst or delayed sustained release of the one or more sleep quality active agents, a delayed burst or delayed sustained release of the one or more sleep recovery active agents, and a delayed burst or delayed sustained release of the one or more next day active agents. The composition can be provided as a daily oral uni-dosage form. Methods of making and using the compositions are also provided. ## Claims ### Claim 1 A composition comprising a multilayer particle consisting essentially of: a) an outer burst release layer comprising one or more sleep promoting active agents, b) an inner sustained release layer comprising one or more sleep quality active agents, and c) a polymer binder coating encapsulating the one or more sleep quality active agents in the inner sustained release layer, wherein upon administration to a subject there is: an immediate burst release of the one or more sleep promoting active agents within about 30 minutes of administration, and delayed release of the one or more sleep quality active agents from about 1 hour to about 6 hours after administration, wherein the polymer binder coating comprises a polymeric binder that delays release of the one or more sleep quality active agents in the inner sustained release layer until from 1 to 6 hours after administration, and wherein each active agent is independently a phytochemical, a herbal extract, a vitamin, a hormone, an amino acid, a mineral, or combinations thereof. ### Claim 2 (depends on 1) The composition of claim 1, wherein delayed release of the sleep quality active agents is selected from a delayed burst release, a delayed sustained release, and combinations thereof. ### Claim 3 (depends on 1) The composition of claim 1, wherein the composition includes at least two sleep promoting active agents selected from the group consisting of melatonin, casein decapeptide, L-tryptophan, γ-aminobutyric acid, and magnesium. ### Claim 4 (depends on 1) The composition of claim 1, wherein the composition includes at least two sleep quality active agents selected from the group consisting of Valerian root extract, an extract from Phellodendron, hops extract, lemon balm extract, and an extract from Magnolia. ### Claim 5 (depends on 1) The composition of claim 1, wherein the sleep quality active agent has a sustained release of 2.5-4.5 hours. ### Claim 6 (depends on 1) The composition of claim 1, 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 in the polymer binder coating. ### Claim 7 (depends on 1) The composition of claim 1, wherein delayed release of the sleep quality active agents comprises a delayed sustained release of the sleep quality active agents. ### Claim 8 (depends on 7) The composition of claim 7, wherein delayed sustained release of at least a portion of the sleep quality active agents is within 2 to 5 hours of administration. ### Claim 9 A composition comprising a multilayer particle consisting essentially of: a) an outer burst release layer comprising one or more sleep promoting active agents, b) an inner sustained release layer comprising one or more sleep quality active, c) a polymer binder coating encapsulating the one or more sleep quality active agents in the inner sustained release layer, and d) a layer comprising one or more of a sleep recovery active agent and/or 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 an immediate burst release of the one or more sleep promoting active agents within about 30 minutes of administration, delayed release of the one or more sleep quality active agents from about 1 hour to about 6 hours after administration, delayed release of the one or more sleep recovery active agents, and/or delayed release of the optional one or more next day active agents, wherein the polymer binder coating comprises a polymeric binder that delays release of the one or more sleep quality active agents in the inner sustained release layer until from 1 to 6 hours after administration, and wherein each active agent is independently a phytochemical, a herbal extract, a vitamin, a hormone, an amino acid, a mineral, and combinations thereof. ### Claim 10 (depends on 1) A method for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject comprising, administering a composition according to claim 1.