Claims for Patent: 10,653,660

Summary for Patent: 10,653,660

Title:	Methods of improving the pharmacokinetics of doxepin
Abstract:	Methods of improving the pharmacokinetics of doxepin in a patient.
Inventor(s):	Casseday; Cara Baron (San Diego, CA), Ludington; Elizabeth (San Diego, CA), Skinner; Michael (San Diego, CA), Dube; Susan E. (Carlsbad, CA), Rogowski; Roberta L. (Rancho Santa Fe, CA), Jochelson; Philip (San Diego, CA), Mansbach; Robert (San Diego, CA)
Assignee:	Currax Pharmaceuticals LLC (Morristown, NJ)
Application Number:	15/436,293
Patent Claims:	1. A method of treating insomnia in a patient in need thereof, the method comprising: administering between about 0.5 mg and about 7 mg doxepin to the patient, wherein the doxepin is administered at least 3 hours after consuming a meal to provide faster onset of action and minimize potential for next day sedation effects. 2. The method of claim 1, wherein the doxepin is administered in an amount of about 3 milligrams. 3. The method of claim 1 wherein the doxepin is administered in an amount of about 6 milligrams. 4. The method of claim 1 wherein the doxepin is administered as a tablet, capsule or liquid. 5. The method of claim 1, wherein the doxepin is administered as a unit dosage form. 6. The method of claim 1, wherein the doxepin is administered as an oral dosage form. 7. The method of claim 1, wherein the doxepin helps the patient fall asleep. 8. The method of claim 1, wherein the doxepin helps the patient stay asleep. 9. The method of claim 1, wherein administration of doxepin to a group of patients after a high fat meal provides an increase in area under the curve (AUC) compared to administration of doxepin to a group of fasted patients. 10. The method of claim 9, wherein the increase in AUC is about 41%. 11. The method of claim 1, wherein administration of doxepin to a group of patients after a high fat meal provides an increase in maximum plasma concentration (C.sub.max) compared to administration of doxepin to a group of fasted patients. 12. The method of claim 11, wherein the increase in C.sub.max is about 15%. 13. The method of claim 1, wherein the doxepin is administered within about one hour of bedtime. 14. The method of claim 1, wherein the doxepin is administered as doxepin hydrochloride. 15. A method of treating insomnia in a patient in need thereof, the method comprising: administering between about 0.5 mg and about 7 mg doxepin to the patient, wherein the doxepin is administered at least 3 hours after consuming a meal, wherein administration of doxepin to a group of patients after a high fat meal compared to administration of doxepin to a group of fasted patients provides: an increase in area under the curve (AUC) of doxepin; an increase in maximum plasma concentration (C.sub.max) of doxepin; or a delay in median time to reach maximum plasma concentration (T.sub.max) of doxepin. 16. The method of claim 15, wherein the increase in AUC is about 41%. 17. The method of claim 15, wherein the increase in C.sub.max is about 15%. 18. The method of claim 15, wherein the delay in T.sub.max is about 3 hours. 19. The method of claim 15, wherein administration of doxepin to a group of patients after a high fat meal compared to administration of doxepin to a group of fasted patients provides: an increase in AUC of about 41%; an increase in C.sub.max of about 15%; and a delay in T.sub.max of about 3 hours.