Claims for Patent: 10,149,829

Summary for Patent: 10,149,829

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), Feeney; John Joseph (Olney, MD), Licamele; Louis William (Potomac, MD), Polymeropoulos; Mihael H. (Potomac, MD)
Assignee:	Vanda Pharmaceuticals Inc. (Washington, DC)
Application Number:	15/382,526
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,149,829
Patent Claims:	1. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil, the method comprising: (A) reducing the dose of the strong CYP1A2 inhibitor treatment and then (B) treating the patient with tasimelteon, wherein the exposure to tasimelteon in a patient being treated with tasimelteon for a circadian rhythm disorder or for a sleep disorder is reduced. 2. The method of claim 1, wherein the CYP1A2 inhibitor is fluvoxamine. 3. The method of claim 2, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder. 4. The method of claim 3, wherein the patient is light perception impaired (LPI). 5. The method of claim 3, wherein treating the patient with tasimelteon comprises orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime. 6. The method of claim 5, wherein the patient is entrained 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. 7. The method of claim 1, wherein the treatment with the strong CYP1A2 inhibitor is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor. 8. The method of claim 2, wherein the treatment with fluvoxamine is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor. 9. The method of claim 1, wherein the CYP1A2 inhibitor is ciprofloxacin. 10. The method of claim 9, wherein the treatment with ciprofloxacin is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor. 11. The method of claim 1, wherein the CYP1A2 inhibitor is verapamil. 12. The method of claim 11, wherein the treatment with verapamil is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor. 13. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil, the method comprising: (A) discontinuing treatment with the strong CYP1A2 inhibitor and then (B) treating the patient with 20 mg of tasimelteon once daily. 14. The method of claim 13, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.