# US 11,890,271 B2 · Time release sleep aid system

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- Number: US 11,890,271 B2
- Document ID: US11890271B2
- Status: Granted
- Kind: B2
- Application number: 17/745,180
- Filed: 2022-05-16
- Published: 2023-01-05
- Granted: 2024-02-06
- Earliest claimed: 2017-06-27
- Assignees: NightWise, LLC
- Applicants: NightWise, LLC
- Inventors: Danny Rinaldi; Scott Forsberg
- Web page: https://patentgrep.com/patent/US11890271B2

## 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 burnt 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 delivery capsule comprising:
a) one or more sleep promoting active agents having immediate burst release within about 30 minutes of administration of the capsule, and
b) one or more sleep quality active encapsulated by a polymeric binder having delayed release from about 1 hour to about 6 hours after administration of the capsule,
wherein the polymeric binder delays release of the one or more sleep quality active agents until from about 1 to about 6 hours after administration of the capsule, and
wherein each active agent is independently a phytochemical, an herbal extract, a vitamin, a hormone, an amino acid, a mineral, and combinations thereof.

### Claim 2 (depends on 1)

The delivery capsule 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 delivery capsule of claim 1, wherein delayed release of the sleep quality active agents comprises a delayed sustained release of the sleep quality active agents.

### Claim 4 (depends on 1)

The delivery capsule of claim 1, wherein delayed sustained release of at least a portion of the sleep quality active agents is within 2 to 5 hours of administration.

### Claim 5 (depends on 1)

The delivery capsule 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 delivery capsule 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, and magnesium.

### Claim 7 (depends on 1)

The delivery capsule of claim 1, wherein the composition includes at least two sleep quality active agents selected from the group consisting of Valerian root extract, hops extract, lemon balm extract, melatonin, and an extract from Magnolia.

### Claim 8 (depends on 1)

The delivery capsule of claim 1, wherein the composition includes at least two sleep quality active agents selected from the group consisting of Valerian root extract, hops extract, lemon balm extract, and melatonin.

### Claim 9 (depends on 1)

The delivery capsule 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.

### Claim 10 (depends on 1)

The delivery capsule of claim 1, wherein the capsule further comprises one or more sleep recovery active agent and/or one or more next day active agents having delayed release after about 6 hours from administration of the capsule.

### Claim 11 (depends on 10)

The delivery capsule of claim 10, wherein the one or more sleep recovery active agents when present, 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, pyridoxine, vitamin B9, vitamin C, vitamin D3, a xanthine, carnosine, 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, cocoa extract, extract from Ginkgo biloba, Panax ginseng, extract from Eleutherococcus senticosus, extract from Centella asiatica, peppermint extract, rosemary extract, wild oats extract, blends thereof, and combinations thereof.