Claims for Patent: 11,141,400

Summary for Patent: 11,141,400

Title:	Method of treatment
Abstract:	One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least 1/2 hour prior to administration, no food at least 1 hour prior to administration, no food at least 11/2 hours prior to administration, no food at least 2 hours prior to administration, no food at least 21/2 hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.
Inventor(s):	Dressman; Marlene Michelle (Germantown, MD), Polymeropoulos; Mihael H. (Potomac, MD), Baroldi; Paolo (Potomac, MD)
Assignee:	Vanda Pharmaceuticals Inc. (Washington, DC)
Application Number:	16/800,611
Patent Claims:	1. A method of avoiding a delayed T.sub.max, a decreased C.sub.max, or both, resulting from the failure to administer tasimelteon without food to a patient suffering from a circadian rhythm disorder or a sleep disorder, the method comprising orally administering to the patient an effective dose of tasimelteon without food, wherein the effective dose is 20 mg/d. 2. The method of claim 1, further comprising instructing the patient that tasimelteon should be taken without food. 3. The method of claim 1, wherein the patient is suffering from a circadian rhythm disorder. 4. The method of claim 3, wherein the circadian rhythm disorder is Non-24 Disorder. 5. The method of claim 1, wherein the tasimelteon is administered with no food after at least one-half hour prior to administration. 6. The method of claim 1, wherein the tasimelteon is administered with no food after at least one hour prior to administration. 7. The method of claim 1, wherein the tasimelteon is administered with no food after at least one-and-one-half hours prior to administration. 8. The method of claim 1, wherein the tasimelteon is administered with no food after at least two hours prior to administration. 9. The method of claim 1, wherein the tasimelteon is administered with no food after at least two-and-one-half hours prior to administration. 10. The method of claim 1, wherein the tasimelteon is administered with no food after at least three hours prior to administration.