# US 2021/0330994 A1 · Treatment and prevention of sleep disorders

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- Number: US 2021/0330994 A1
- Document ID: US20210330994A1
- Status: Published application
- Kind: A1
- Application number: 17/195,434
- Filed: 2021-03-08
- Published: 2021-10-28
- Earliest claimed: 2016-07-26
- Assignees: Purdue Pharma L.P.
- Applicants: Purdue Pharma L.P.
- Inventors: Stephen C. HARRIS; Ram P. KAPIL; Donald J. KYLE; Garth WHITESIDE
- Web page: https://patentgrep.com/patent/US20210330994A1

## CPC

- A61K 31/498: Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61M 21/00: Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- 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
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The disclosure relates to methods for treating or preventing a sleep disorder by administering a compound of formula (1)(1), or a compound of formula (1A), (1B), (1C), (1D), (1E), or (1F) to an animal in need of such treatment. In certain embodiments, such compounds effectively treat or prevent a sleep disorder in the animal, while producing reduced side effects compared to previously available compounds.

## Claims

### Claim at position 1

1-96. (canceled)

### Claim 97

A method for treating a sleep disorder, comprising administering to a human patient in need thereof from about 0.05 mg to about 100 mg of a compound of Formula (1)
or a pharmaceutically acceptable salt thereof.

### Claim 98 (depends on 97)

The method of claim 97, wherein the compound is a compound of Formula (1A)
or a pharmaceutically acceptable salt thereof.

### Claim 99 (depends on 97)

The method of claim 97, wherein the compound is a compound of Formula (1B)
or a pharmaceutically acceptable salt thereof.

### Claim 100 (depends on 97)

The method of claim 97, wherein the compound is a compound of Formula (1C)
or a pharmaceutically acceptable salt thereof.

### Claim 101 (depends on 97)

The method of claim 97, wherein the sleep disorder is an insomnia condition, a hypersomnia condition, a circadian rhythm sleep-wake disorder, an alcohol-induced sleep disorder, or any combination thereof.

### Claim 102 (depends on 101)

The method of claim 101, wherein the alcohol-induced sleep disorder is insomnia-type alcohol-induced sleep disorder, daytime sleepiness type alcohol-induced sleep disorder, parasomnia type alcohol-induced sleep disorder, mixed type alcohol-induced sleep disorder, insomnia in alcohol use disorder, a sleep disorder associated with alcohol cessation, insomnia associated with alcohol cessation, or any combination thereof.

### Claim 103 (depends on 97)

The method of claim 97, wherein administration of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is by at least one route selected from oral, parenteral, intravenous, intramuscular, buccal, gingival, sublingual, intraocular, transdermal, and transmucosal.

### Claim 104 (depends on 103)

The method of claim 103, wherein administration of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is by oral, sublingual, gingival, or buccal administration.

### Claim 105 (depends on 97)

The method of claim 97, wherein said administration is a single daily human dose of the compound of Formula (1) or a pharmaceutically acceptable salt thereof from about 0.10 mg to about 15 mg.

### Claim 106 (depends on 105)

The method of claim 105, wherein the single daily human dose of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is from about 0.2 mg to about 6.0 mg.

### Claim 107 (depends on 97)

The method of claim 97, wherein said administration is a single daily dose of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is administered to the patient on at least two consecutive days; and wherein the patient exhibits an average improvement versus baseline in Total Sleep Time (TST), Sleep Efficiency (SE), Latency to Persistent Sleep (LPS), Total Wake Time (TWT), Wake During Sleep (WDS), Wake After Sleep Onset (WASO), Number of Awakenings (NAW), REM latency, or any combination thereof.

### Claim 108 (depends on 107)

The method of claim 107, wherein the patient exhibits an average improvement in total sleep time, sleep efficiency, latency to persistent sleep, wake after sleep onset, or any combination thereof.

### Claim 109 (depends on 108)

The method of claim 108, wherein the patient exhibits an average improvement in total sleep time, sleep efficiency, latency to persistent sleep, and wake after sleep onset.

### Claim 110

A method for preventing a sleep disorder, comprising administering to a human patient in need thereof from about 0.05 mg to about 100 mg of a compound of Formula (1)
or a pharmaceutically acceptable salt thereof.

### Claim 111 (depends on 110)

The method of claim 110, wherein the sleep disorder is an insomnia condition, a hypersomnia condition, a circadian rhythm sleep-wake disorder, an alcohol-induced sleep disorder, or any combination thereof.

### Claim 112 (depends on 111)

The method of claim 111, wherein the alcohol-induced sleep disorder is insomnia-type alcohol-induced sleep disorder, daytime sleepiness type alcohol-induced sleep disorder, parasomnia type alcohol-induced sleep disorder, mixed type alcohol-induced sleep disorder, insomnia in alcohol use disorder, a sleep disorder associated with alcohol cessation, insomnia associated with alcohol cessation, or any combination thereof.

### Claim 113 (depends on 112)

The method of claim 112, wherein administration of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is by at least one route selected from oral, parenteral, intravenous, intramuscular, buccal, gingival, sublingual, intraocular, transdermal, and transmucosal.

### Claim 114 (depends on 113)

The method of claim 113, wherein administration of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is by oral, sublingual, gingival, or buccal administration.

### Claim 115 (depends on 110)

The method of claim 110, wherein said administration is a single daily human dose of the compound of Formula (1) or a pharmaceutically acceptable salt thereof from about 0.10 mg to about 15 mg.

### Claim 116 (depends on 115)

The method of claim 115, wherein the single daily human dose of the compound of Formula (1) or a pharmaceutically acceptable salt thereof is from about 0.2 mg to about 6.0 mg.