Claims for Patent: 11,786,502

Summary for Patent: 11,786,502

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 ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ 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):	Marlene Michelle Dressman, Mihael H. Polymeropoulos, Paolo Baroldi
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US17/407,921
Patent Claims:	1. In a method of administering tasimelteon to an individual, the improvement comprising: orally administering to the patient a dose of tasimelteon without food and with no food after at least one-half hour prior to orally administering. 2. The improvement of claim 1, wherein the tasimelteon is administered with no food after at least one hour prior to administration. 3. The improvement of claim 1, wherein the tasimelteon is administered with no food after at least one-and-one-half hours prior to administration. 4. The improvement of claim 1, wherein the tasimelteon is administered with no food after at least two hours prior to administration. 5. The improvement of claim 1, wherein the tasimelteon is administered with no food after at least about two-and-one-half hours prior to administration. 6. The improvement of claim 1, wherein the tasimelteon is administered with no food after at least three hours prior to administration. 7. The improvement of claim 1, wherein the tasimelteon is administered once daily before a target bedtime. 8. A method of treating a human patient suffering from a sleep disturbance, the method comprising: instructing the patient that tasimelteon should be taken without food; and orally administering to the patient a dose of tasimelteon without food and with no food after at least one-half hour prior to administration. 9. The method of claim 8, wherein the tasimelteon is administered with no food after at least one hour prior to administration. 10. The method of claim 8, wherein the tasimelteon is administered with no food after at least one-and-one-half hours prior to administration. 11. The method of claim 8, wherein the tasimelteon is administered with no food after at least two hours prior to administration. 12. The method of claim 8, wherein the tasimelteon is administered with no food after at least two-and-one-half hours prior to administration. 13. The method of claim 8, wherein the tasimelteon is administered with no food after at least three hours prior to administration. 14. A method of treating a human patient suffering from a sleep disturbance, the method comprising: instructing the patient that tasimelteon should be taken without food; and orally administering to the patient a dose of tasimelteon without food and with no food after at least one-half hour prior to administration, wherein Cmax of the tasimelteon is lowered while AUC is approximately the same whether the tasimelteon is administered under fed conditions or under fasted conditions. 15. The improvement of claim 1, further comprising: instructing the patient, prior to orally administering to the patient the dose of tasimelteon, that tasimelteon should be taken without food.