# US 2017/0280749 A1 · Antihistamines Combined with Dietary Supplements for Improved Health

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- Number: US 2017/0280749 A1
- Document ID: US20170280749A1
- Status: Published application
- Kind: A1
- Application number: 15/620,038
- Filed: 2017-06-12
- Published: 2017-10-05
- Earliest claimed: 2011-06-09
- Assignees: Requis Pharmaceuticals Inc.
- Applicants: Requis Pharmaceuticals
- Inventors: Lars Jacob Stray Knutsen; Judi Lois Knutsen; James M HAND
- Web page: https://patentgrep.com/patent/US20170280749A1

## CPC

- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/4402: only substituted in position 2, e.g. pheniramine, bisacodyl
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/495: having six-membered rings with two {or more} nitrogen atoms as the only ring heteroatoms, e.g. piperazine {or tetrazines}(A61K31/48 takes precedence {; with three nitrogen atoms A61K31/53})
- A61K 31/56: Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A23V 2250/065: Tryptophan
- A23V 2250/30: Other Organic compounds
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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)
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The present invention provides combinations comprising a sedating antihistamine and selected indole-based natural products such as L-tryptophan, 5-hydroxytryptophan and melatonin, along with pharmaceutically acceptable calcium and magnesium salts and selected B vitamins. These combinations are useful in providing a medicament for improving sleep in mammals, especially humans.

## Claims

### Claim 1

A method of inducing restorative sleep function comprising administering a pharmaceutical composition comprising an enterically coated tablet, locking capsule or beverage for ingestion and a mixture of an antihistamine drug and two or more indole-based dietary supplements.

### Claim 2 (depends on 1)

The method of claim 1, the antihistamine drug is selected from a group consisting of Cetirizine, Chlorpheniramine, Clemastine, Desloratadine, Dexchlorpheniramine, Dimenhydrinate, Dimetindene, Diphenhydramine, Doxylamine, Ebastine, Embramine, Fexofenadine, Levocetirizine, Loratadine, Meclozine, Olopatadine, Pheniramine, Promethazine Triprolidine, and pharmaceutically-acceptable salts thereof.

### Claim 3 (depends on 1)

The method of claim 1 wherein one of the indole-based dietary supplement is L-tryptophan or a derivative of L-tryptophan.

### Claim 4 (depends on 3)

The method of claim 3 wherein the pharmaceutical composition further comprises melatonin and its pharmaceutically acceptable salts.

### Claim 5 (depends on 1)

The method of claim 1 wherein the antihistamine drug is a metabolite of the compounds selected from a group consisting of Cetirizine, Chlorpheniramine, Clemastine, Dexchlorpheniramine, Dimenhydrinate, Dimetindene, Diphenhydramine, Doxylamine, Ebastine, Embramine, Fexofenadine, Levocetirizine, Loratadine, Meclozine, Olopatadine, Pheniramine, Promethazine Triprolidine, and pharmaceutically-acceptable salts thereof.

### Claim 6 (depends on 1)

The method of claim 1 wherein the composition further includes at least one vitamin and pharmaceutically acceptable minerals to enhance the effect of the indole-based compounds.

### Claim 7 (depends on 1)

The method of claim 1 wherein the composition further includes pharmaceutically acceptable calcium salts, magnesium salts, and at least one pyridine-based vitamin.

### Claim 8 (depends on 1)

The method of claim 1 wherein inducing restorative sleep function comprises preventing or ameliorating a sleep related breathing disorder.

### Claim 9 (depends on 8)

The method of claim 8 wherein sleep related breathing disorder is selected from a group consisting of snoring, sleep disordered breathing, sleep apneas, upper airway resistance syndrome, obstructive sleep apnea, central sleep apnea, hypopnea, catathrenia, obesity hypoventilation syndrome, central apnea syndromes, Cheyne-Stokes respiration, Obstructive Sleep Apnea Syndrome, Upper Airway Resistance Syndrome, Alveolar hypoventilation syndrome, Pickwickian syndrome and combinations thereof.

### Claim 10 (depends on 9)

The method of claim 9 wherein sleep related breathing disorder is snoring.

### Claim 11 (depends on 9)

The method of claim 9 wherein sleep related breathing disorder is sleep disordered breathing.

### Claim 12 (depends on 9)

The method of claim 9 wherein sleep related breathing disorder is obstructive sleep apnea syndrome.

### Claim 13 (depends on 2)

The method of claim 2 wherein inducing restorative sleep function comprises preventing or ameliorating a sleep related breathing disorder.

### Claim 14 (depends on 13)

The method of claim 13 wherein sleep related breathing disorder is selected from a group consisting of snoring, sleep disordered breathing, sleep apneas, upper airway resistance syndrome, obstructive sleep apnea, central sleep apnea, hypopnea, catathrenia, obesity hypoventilation syndrome, central apnea syndromes, Cheyne-Stokes respiration, Obstructive Sleep Apnea Syndrome, Upper Airway Resistance Syndrome, Alveolar hypoventilation syndrome, Pickwickian syndrome and combinations thereof.

### Claim 15 (depends on 14)

The method of claim 14 wherein sleep related breathing disorder is snoring.

### Claim 16 (depends on 14)

The method of claim 14 wherein sleep related breathing disorder is sleep disordered breathing.

### Claim 17 (depends on 14)

The method of claim 14 wherein sleep related breathing disorder is obstructive sleep apnea syndrome.
