Claims for Patent: 10,653,662

Summary for Patent: 10,653,662

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:	Currax Pharmaceuticals LLC (Morristown, NJ) ProCom One, Inc. (Steamboat Springs, CO)
Application Number:	16/363,128
Patent Claims:	1. A method for treating insomnia, the method comprising: administering an oral formulation comprising 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 has difficulty staying asleep during the final 60 minutes of said period, wherein the oral formulation comprises a dosage of doxepin between about 1 and about 7 mg and is administered prior to bedtime. 2. The method of claim 1, wherein the oral formulation is effective to improve the insomnia while minimizing next day residual sedation. 3. The method of claim 1, wherein the oral formulation comprises one or more tablets. 4. The method of claim 3, wherein each tablet comprises a dosage of doxepin of about 3 mg. 5. The method of claim 1, wherein the oral formulation comprises one or more capsules. 6. The method of claim 1, wherein the patient has difficulty staying asleep during the final 45 minutes of said period. 7. The method of claim 1, wherein the patient has difficulty staying asleep 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. The method of claim 1, where in the patient is 18 to under 65 years of age. 13. The method of claim 12, wherein the dosage of doxepin is about 3 mg or about 6 mg. 14. The method of claim 13, wherein the dosage of doxepin is about 3 mg. 15. The method of claim 13, where in the dosage of doxepin is about 6 mg. 16. The method of claim 1, wherein the patient is 65 years of age or older. 17. The method of claim 16, wherein the dosage of doxepin is about 3 mg.