IP Library Granted Patent US 10,238,620
Granted Patent B2
US 10,238,620 · App. 15/864,440 · Granted Mar 26, 2019

Methods of using low-dose doxepin for the improvement of sleep

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Quick Facts
Patent No.
US 10,238,620
App. No.
15/864,440
Granted
Mar 26, 2019
Kind
B2
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).

Claims (22)

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.

Assignments (2)
SECURITY INTEREST Recorded Dec 19, 2019
From: CURRAX PHARMACEUTICALS LLC; NALPROPION PHARMACEUTICALS LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB
Reel/Frame 051377/0958 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 31, 2019
From: PERNIX SLEEP, INC.
To: CURRAX PHARMACEUTICALS LLC
Reel/Frame 049329/0730 →