Claims for Patent: 9,861,607

Summary for Patent: 9,861,607

Title:	Methods of using low-dose doxepin for the improvement of sleep
Abstract:	Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Inventor(s):	Rogowski; Roberta L. (Rancho Santa Fe, CA), Dube; Susan E. (Carlsbad, CA), Jochelson; Philip (San Diego, CA), Kavey; Neil B. (Chappaqua, NY)
Assignee:	Procom One, Inc. (San Marcos, TX) Pernix Sleep, Inc. (Morristown, NJ)
Application Number:	15/344,710
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,861,607
Patent Claims:	1. A method for treating insomnia characterized by difficulties with sleep maintenance, the method comprising: administering a dosage of doxepin or a pharmaceutically acceptable salt thereof to a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences fragmented sleep during the final 60 minutes of said period, wherein the dosage of doxepin is between about 1 and about 6 mg and is administered prior to the start of the sleep period. 2. The method of claim 1, wherein the dosage is effective to improve the insomnia while minimizing next day residual sedation. 3. The method of claim 1, wherein the insomnia is a chronic insomnia. 4. The method of claim 1, wherein the insomnia is a non-chronic insomnia. 5. The method of claim 1, wherein the insomnia is a transient insomnia. 6. The method of claim 1, wherein the patient experiences a sleep period that terminates during the final 45 minutes of said period. 7. The method of claim 1, wherein the patient experiences a sleep period that terminates during the final 30 minutes of said period. 8. The method of claim 1, wherein the dosage of doxepin is about 1 mg. 9. The method of claim 1, wherein the dosage of doxepin is about 3 mg. 10. The method of claim 1, wherein the dosage of doxepin is about 6 mg. 11. The method of claim 1, wherein the pharmaceutically acceptable salt is doxepin hydrochloride. 12. A method for treating insomnia characterized by difficulties with sleep maintenance, the method comprising: administering a dosage of doxepin or a pharmaceutically acceptable salt thereof to a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences early awakenings during the final 60 minutes of said period, wherein the dosage of doxepin is between about 1 and about 6 mg and is administered prior to the start of the sleep period. 13. The method of claim 12, wherein the dosage is effective to improve the insomnia while minimizing next day residual sedation. 14. The method of claim 12, wherein the insomnia is a chronic insomnia. 15. The method of claim 12, wherein the insomnia is a non-chronic insomnia. 16. The method of claim 12, wherein the insomnia is a transient insomnia. 17. The method of claim 12, wherein the dosage of doxepin is about 1 mg. 18. The method of claim 12, wherein the dosage of doxepin is about 3 mg. 19. The method of claim 12, wherein the dosage of doxepin is about 6 mg. 20. The method of claim 12, wherein the pharmaceutically acceptable salt is doxepin hydrochloride.