IP Library Granted Patent US 9,486,437
Granted Patent B2
US 9,486,437 · App. 14/804,595 · Granted Nov 8, 2016

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

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Quick Facts
Patent No.
US 9,486,437
App. No.
14/804,595
Granted
Nov 8, 2016
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 (20)

1. A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8 th hour of sleep, 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 0.5 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 sleep maintenance insomnia while minimizing next day residual sedation.

3. The method of claim 1 , wherein the sleep maintenance insomnia is a chronic insomnia.

4. The method of claim 1 , wherein the sleep maintenance insomnia is a non-chronic insomnia.

5. The method of claim 1 , wherein the sleep maintenance 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. A method for treating sleep maintenance insomnia characterized by early awakenings during the 8 th hour of sleep, 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 0.5 and about 6 mg and is administered prior to the start of the sleep period.

12. The method of claim 11 , wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation.

13. The method of claim 11 , wherein the sleep maintenance insomnia is a chronic insomnia.

14. The method of claim 11 , wherein the sleep maintenance insomnia is a non-chronic insomnia.

15. The method of claim 11 , wherein the sleep maintenance insomnia is a transient insomnia.

16. The method of claim 11 , wherein the dosage of doxepin is about 1 mg.

17. The method of claim 11 , wherein the dosage of doxepin is about 3 mg.

18. The method of claim 11 , wherein the dosage of doxepin is about 6 mg.

Assignments (3)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2015
From: PERNIX THERAPEUTICS HOLDINGS, INC.
To: PERNIX SLEEP, INC.
Reel/Frame 036387/0667 →