Claims for Patent: 9,549,913

Summary for Patent: 9,549,913

Title:	Treatment of circadian rhythm disorders
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.
Inventor(s):	Dressman; Marlene Michelle (Germantown, MD), Licamele; Louis William (Potomac, MD), Polymeropoulos; Mihael H. (Potomac, MD)
Assignee:	Vanda Pharmaceuticals, Inc. (Washington, DC)
Application Number:	14/374,257
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,549,913
Patent Claims:	1. A method of entraining a patient's cortisol circadian rhythm to a 24-hour circadian rhythm and maintaining said 24-hour circadian rhythm, the method comprising: treating the patient by orally administering to the patient tasimelteon once daily before a target bedtime. 2. The method of claim 1, wherein the patient is light perception impaired (LPI). 3. The method of claim 1, wherein the patient is totally blind. 4. The method of claim 1, wherein the patient suffers from Non-24-Hour Sleep-Wake Disorder. 5. The method of claim 1, 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. 6. The method of claim 1, wherein the tasimelteon is orally administered 0.5 hours to 1.5 hours before the target bedtime. 7. The method of claim 1, wherein treatment is initiated on a day in which the patient's urinary cortisol acrophase is predicted to be within about 5.5 hours before a target wake time and about 2.5 hours after the target wake time. 8. The method of claim 1, wherein treatment is initiated on a day in which the patient's urinary aMT6s acrophase is predicted to be within about 5.5 hours before a target wake time and about 2.5 hours after the target wake time. 9. The method of claim 1, wherein the administering includes administering between about 10 mg and 100 mg of tasimelteon. 10. The method of claim 1, wherein the administering includes administering between about 20 mg and about 50 mg of tasimelteon. 11. The method of claim 1, wherein the administering includes administering about 20 mg of tasimelteon. 12. The method of claim 4, 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. 13. The method of claim 5, wherein the tasimelteon is orally administered 0.5 hours to 1.5 hours before the target bedtime. 14. The method of claim 6, wherein the administering includes administering about 20 mg of tasimelteon.