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Last Updated: October 30, 2020

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Claims for Patent: 10,238,620

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Summary for Patent: 10,238,620
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: Pernix Sleep, Inc. (Morristown, NJ) ProCom One, Inc. (San Marcos, TX)
Application Number:15/864,440
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 experiences fragmented sleep 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 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, 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 experiences early awakenings 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.

13. The method of claim 12, wherein the oral formulation is effective to improve the insomnia while minimizing next day residual sedation.

14. The method of claim 12, wherein the oral formulation comprises one or more tablets.

15. The method of claim 14, wherein each tablet comprises a dosage of doxepin of about 3 mg.

16. The method of claim 12, wherein the oral formulation comprises one or more capsules.

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.

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