Claims for Patent: 10,610,511

Summary for Patent: 10,610,511

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:	16/517,111
Patent Claims:	1. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder, the method comprising: instructing the patient that tasimelteon should be taken without food; and orally administering to the patient an effective dose of tasimelteon without food. 2. The method of claim 1, wherein the tasimelteon is administered with no food after at least 1/2 hour prior to administration. 3. The method of claim 1, wherein C.sub.max of the tasimelteon is lowered while AUC is approximately the same whether the tasimelteon is administered under fed conditions or under fasted conditions. 4. The method of claim 1, wherein the patient is suffering from a circadian rhythm disorder. 5. The method of claim 4, wherein the circadian rhythm disorder is Non-24 Disorder. 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. 11. The method of claim 1, wherein the effective dose is 20 mg/d. 12. In a method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder by orally administering to the patient 20 mg/d of tasimelteon once daily before a target bedtime, the improvement comprising: instructing the patient that tasimelteon should be taken without food, wherein the patient has had no food for at least 1/2 hour prior to the administering. 13. The improvement of claim 12, wherein the patient has had no food for at least one hour prior to the administering. 14. The improvement of claim 12, wherein the patient has had no food for at least one-and-one-half hours prior to the administering. 15. The improvement of claim 12, wherein the patient has had no food for at least two hours prior to the administering. 16. The improvement of claim 12, wherein the patient has had no food for at least two-and-one-half hours prior to the administering. 17. The improvement of claim 12, wherein the patient has had no food for at least three hours prior to the administering. 18. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder that comprises instructing the patient that tasimelteon should be taken without food before orally administering to the patient an effective dose of tasimelteon without food. 19. The method of claim 18, wherein the effective dose is 20 mg/d.