# US 10,945,988 B2 · Treatment of circadian rhythm disorders

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- Number: US 10,945,988 B2
- Document ID: US10945988B2
- Status: Granted
- Kind: B2
- Application number: 16/571,106
- Filed: 2019-09-14
- Published: 2020-01-09
- Granted: 2021-03-16
- Earliest claimed: 2012-01-26
- Assignees: Vanda Pharmaceuticals Inc.
- Applicants: Vanda Pharmaceuticals Inc.
- Inventors: Marlene Michelle Dressman; Louis William Licamele; Mihael H. Polymeropoulos
- Web page: https://patentgrep.com/patent/US10945988B2

## CPC

- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/05: Phenols {(cannabinoids A61K31/658)}
- A61K 31/15: Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) {; Imines (C—N=C)}
- A61K 31/277: having a ring, e.g. verapamil
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 5/38: of the suprarenal hormones
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 27/00: Drugs for disorders of the senses
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G01N 30/7233: {interfaced to liquid or supercritical fluid chromatograph (interfaces in general for introducing or extracting samples to be analysed with specially adapted mass spectrometer, see H01J49/04)}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors}
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G01N 2800/2864: Sleep disorders
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

## Claims

### Claim 1

A method of treating a disorder associated with a desynchronous cortisol circadian rhythm in a patient having a desynchronous cortisol circadian rhythm, said method comprising internally administering to the patient an effective amount of tasimelteon.

### Claim 2 (depends on 1)

The method of claim 1, wherein the patient is light perception impaired (LPI).

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient is totally blind.

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient suffers from Non-24-Hour Sleep-Wake Disorder.

### Claim 5 (depends on 1)

The method of claim 1, wherein the tasimelteon is orally administered 0.5 hours to 1.5 hours before a target bedtime.

### Claim 6 (depends on 1)

The method of claim 1, wherein the effective amount is between 1 mg/d and 100 mg/d.

### Claim 7 (depends on 1)

The method of claim 1, wherein the effective amount is between 10 mg/d and 100 mg/d.

### Claim 8 (depends on 1)

The method of claim 1, wherein the effective amount is 20 mg/d.

### Claim 9 (depends on 1)

The method of claim 1, wherein the effective amount is 50 mg/d.

### Claim 10 (depends on 1)

The method of claim 1, wherein the effective amount is sufficient to synchronize the patient's cortisol circadian rhythm with a natural day/night cycle.

### Claim 11 (depends on 1)

The method of claim 1, wherein the effective amount is sufficient to entrain the patient's cortisol circadian rhythm to a 24-hour circadian rhythm.

### Claim 12 (depends on 11)

The method of claim 11, wherein the administration of the effective amount of tasimelteon is continued to maintain said entrainment to the 24-hour circadian rhythm.

### Claim 13 (depends on 11)

The method of claim 11, wherein the 24-hour circadian rhythm comprises a 24-hour sleep-wake cycle in which the patient awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours.