Claims for Patent: 9,572,814

Summary for Patent: 9,572,814

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:	Pernix Sleep, Inc. (Morristown, NJ)
Application Number:	13/653,213
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,572,814
Patent Claims:	1. A method of treating insomnia, the method comprising administering between about 0.5 mg and about 7 mg doxepin to a patient in need thereof, wherein the doxepin is administered before bedtime and at least three hours after consuming a meal, thereby providing a faster onset of action and reducing next day residual 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 is administered within about one hour of bedtime. 8. A method for treating sleep maintenance insomnia, the method comprising: administering between about 1 mg and about 6 mg doxepin to a patient in need thereof, wherein the doxepin is administered within about one hour before bedtime and at least three hours after consuming a meal, thereby providing a faster onset of action and reducing next day residual effects. 9. The method of claim 8, wherein the doxepin is administered in an amount of about 3 mg. 10. The method of claim 8, wherein the doxepin is administered in an amount of about 6 mg. 11. The method of claim 8, wherein the doxepin is administered as a tablet, capsule or liquid. 12. The method of claim 8, wherein the method shortens the median time to reach maximum plasma concentration (T.sub.max) of doxepin in the patient compared to administering the doxepin with a high fat meal. 13. The method of claim 8, wherein the method decreases the maximum plasma concentration (C.sub.max) of doxepin in the patient compared to administering the doxepin with a high fat meal. 14. The method of claim 8, wherein the method decreases the area under the curve (AUC) of doxepin in the patient compared to administering the doxepin with a high fat meal.