# US 2021/0330634 A1 · Treatment of circadian rhythm disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330634 A1 - Document ID: US20210330634A1 - Status: Published application - Kind: A1 - Application number: 17/368,160 - Filed: 2021-07-06 - Published: 2021-10-28 - Earliest claimed: 2012-01-26 - Assignees: Vanda Pharmaceuticals Inc. - Applicants: Vanda Pharmaceuticals Inc. - Inventors: Marlene Michelle Dressman; John Joseph Feeney; Louis William Licamele; Mihael H. Polymeropoulos - Web page: https://patentgrep.com/patent/US20210330634A1 ## 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 In a method of administering tasimelteon to a patient, the improvement comprising: determining whether the patient is being treated with a beta-adrenergic receptor antagonist; and in the case that it is determined that the patient is not being treated with a beta-adrenergic receptor antagonist, administering to the patient 20 mg of tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime; or in the case that it is determined that the patient is being treated with a beta-adrenergic receptor antagonist: instructing the patient to cease treatment with the beta-adrenergic receptor antagonist; and then administering to the patient 20 mg of tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime. ### Claim 2 (depends on 1) The improvement of claim 1, wherein the beta-adrenergic receptor antagonist is selected from a group consisting of: alprenolol, altenolol, carvedilol, metoprolol, and propranolol. ### Claim 3 (depends on 2) The improvement of claim 2, wherein the patient is suffering from Non-24-Hour Sleep-Wake Disorder. ### Claim 4 In a method of administering tasimelteon to a patient, the improvement comprising: determining whether the patient is being treated with a beta-adrenergic receptor antagonist; and in the case that it is determined that the patient is not being treated with a beta-adrenergic receptor antagonist, administering to the patient 20 mg of tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime; or in the case that it is determined that the patient is being treated with a beta-adrenergic receptor antagonist, discontinuing beta-adrenergic receptor antagonist treatment before administering to the patient 20 mg of tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime. ### Claim 5 (depends on 4) The improvement of claim 4, wherein the beta-adrenergic receptor antagonist is selected from a group consisting of: alprenolol, altenolol, carvedilol, metoprolol, and propanolol. ### Claim 6 (depends on 5) The improvement of claim 5, wherein the patient is suffering from Non-24-Hour Sleep-Wake Disorder. ### Claim 7 A method of treating a patient for a circadian rhythm disorder or a sleep disorder wherein the patient is being treated with a beta-adrenergic receptor antagonist, the method comprising: discontinuing treatment with the beta-adrenergic receptor antagonist; and then administering to the patient with 20 mg tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime; thereby avoiding decreased efficacy of tasimelteon treatment due to co-administration with the beta-adrenergic receptor antagonist. ### Claim 8 (depends on 7) The method of claim 7, wherein the beta-adrenergic receptor antagonist is selected from a group consisting of: alprenolol, altenolol, carvedilol, metoprolol, and propranolol. ### Claim 9 (depends on 8) The method of claim 8, wherein the patient is suffering from Non-24-Hour Sleep-Wake Disorder. ### Claim 10 A method of entraining a patient suffering from Non-24-Hour Sleep-Wake Disorder to 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, wherein the patient is being treated with a beta-adrenergic receptor antagonist, the method comprising: discontinuing treatment with the beta-adrenergic receptor antagonist; and then administering to the patient with 20 mg tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime. ### Claim 11 (depends on 10) The method of claim 10, wherein the beta-adrenergic receptor antagonist is selected from a group consisting of: alprenolol, altenolol, carvedilol, metoprolol, and propranolol. ### Claim 12 (depends on 11) The method of claim 11, wherein the patient is light perception impaired. ### Claim 13 (depends on 12) The method of claim 12, wherein the patient is totally blind.