Claims for Patent: 10,980,770

Summary for Patent: 10,980,770

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):	Marlene Michelle Dressman, John Joseph Feeney, Louis William Licamele, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US16/792,275
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,980,770
Patent Claims:	1. In a method of administering tasimelteon to a patient, the improvement comprising: determining whether the patient is a smoker; determining whether the patient is being treated with a CYP1A2 inhibitor; and in the case that it is determined that the patient is not a smoker and is not being treated with a CYP1A2 inhibitor, administering to the patient 20 mg of tasimelteon once daily before a target bedtime; or in the case that it is determined that the patient is a smoker: instructing the patient to cease or reduce smoking; and then administering to the patient 20 mg of tasimelteon once daily before the target bedtime; or in the case that it is determined that the patient is being treated with a CYP1A2 inhibitor: discontinuing the treatment with the CYP1A2 inhibitor; and then administering to the patient 20 mg of tasimelteon once daily before the target bedtime. 2. The improvement of claim 1, wherein the CYP1A2 inhibitor is a strong CYP1A2 inhibitor. 3. The improvement of claim 2, wherein the strong CYP1A2 inhibitor is selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil. 4. The improvement of claim 1, wherein administering includes administering the tasimelteon 0.5 hour to 1.5 hours before the target bedtime. 5. The improvement of claim 4, wherein administering includes administering the tasimelteon one hour before the target bedtime. 6. The improvement of claim 1, wherein the patient is suffering from a circadian rhythm disorder or a sleep disorder. 7. The improvement of claim 1, wherein the patient is suffering from Non-24-Hour Sleep-Wake Disorder. 8. The improvement of claim 1, wherein administering to the patient 20 mg of tasimelteon once daily before the target bedtime entrains the patient 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. 9. The improvement of claim 8, wherein administering to the patient 20 mg of tasimelteon once daily before the target bedtime maintains said 24-hour sleep-wake cycle. 10. The improvement of claim 8, wherein administering is initiated on a day in which the patient's urinary aMT6s acrophase is predicted to be within about 5.5 hours before the target wake time and about 2.5 hours after the target wake time. 11. The improvement of claim 1, wherein administering to the patient 20 mg of tasimelteon once daily before the target bedtime advances the patient's circadian rhythm. 12. The improvement of claim 11, wherein administering to the patient 20 mg of tasimelteon once daily before the target bedtime advances the patient's circadian rhythm up to about five hours.