IP Library Granted Patent US 8,513,299
Granted Patent B2
US 8,513,299 · App. 11/804,720 · Granted Aug 20, 2013

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

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Quick Facts
Patent No.
US 8,513,299
App. No.
11/804,720
Granted
Aug 20, 2013
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 (28)

1. A method for reducing or preventing early awakenings in a patient in need thereof, comprising:

identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences a sleep period that terminates during the final 60 minutes of said period; and

providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 and 6 mg that is effective to lengthen the sleep period.

2. The method of claim 1 , wherein the patient is identified as experiencing a sleep period that terminates during the final 45 minutes of said period.

3. The method of claim 1 , wherein the patient is identified as experiencing a sleep period that terminates during the final 30 minutes of said period.

4. The method of claim 1 , wherein the dosage is sufficient to lengthen the sleep period to terminate during the 8 th hour of said period.

5. The method of claim 1 , wherein the sleep period is lengthened to terminate after hour 7.5 of said period.

6. The method of claim 1 , wherein the patient is additionally identified as in need of reducing wake time after sleep.

7. The method of claim 1 , wherein the patient suffers from chronic or non-chronic insomnia.

8. The method of claim 7 , wherein the patient suffers from transient insomnia.

9. A method for decreasing fragmented sleep in the 8th hour of a sleep period for a patient, comprising:

identifying a patient suffering from fragmented sleep during the 8th hour of a sleep period; and

providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 mg and 6 mg.

10. The method of claim 9 , wherein said dosage of doxepin is about 1 mg, 3 mg or 6 mg.

11. The method of claim 10 , wherein said dosage of doxepin is about 0.5 mg.

12. The method of claim 10 , wherein said dosage of doxepin is about 1 mg.

13. The method of claim 10 , wherein said dosage of doxepin is about 3 mg.

14. The method of claim 10 , wherein said dosage of doxepin is about 6 mg.

15. The method of claim 9 , wherein said patient suffers from chronic or non-chronic insomnia.

16. The method of claim 15 , wherein the patient suffers from transient insomnia.

17. The method of claim 1 , wherein said dosage of doxepin is about 1 mg, 3 mg or 6 mg.

18. The method of claim 1 , wherein said dosage of doxepin is about 0.5 mg.

19. The method of claim 1 , wherein said dosage of doxepin is about 1 mg.

20. The method of claim 1 , wherein said dosage of doxepin is about 3 mg.

21. The method of claim 1 , wherein said dosage of doxepin is about 6 mg.

22. A method for reducing early awakenings in a patient in need thereof, comprising:

identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences a sleep period that terminates during the final 60 minutes of said period; and

providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 and 6 mg.

Assignments (11)
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 →
RELEASE OF SECURITY INTEREST IN PATENT RIGHTS REEL/FRAME 030441/0229 Recorded Feb 24, 2014
From: MIDCAP FUNDING IV, LLC (SUCCESSOR IN INTEREST TO MIDCAP FINANCIAL, LLC)
To: PERNIX SLEEP, INC.
Reel/Frame 032330/0023 →
MERGER Recorded Feb 3, 2014
From: PERNIX SLEEP, INC.
To: PERNIX THERAPEUTICS HOLDINGS, INC.
Reel/Frame 032118/0135 →
PATENT TRANSFER AND ASSIGNMENT Recorded Sep 13, 2013
From: MIDCAP FUNDING V, LLC
To: MIDCAP FINANCIAL, LLC
Reel/Frame 031266/0437 →
PATENT TRANSFER AND ASSIGNMENT Recorded Sep 13, 2013
From: MIDCAP FINANCIAL, LLC
To: MIDCAP FUNDING IV, LLC
Reel/Frame 031266/0572 →
MERGER Recorded Jul 17, 2013
From: SOMAXON PHARMACEUTICALS, INC.
To: PERNIX SLEEP, INC.
Reel/Frame 030819/0883 →
SECURITY AGREEMENT Recorded May 17, 2013
From: PERNIX SLEEP, INC.
To: MIDCAP FINANCIAL, LLC
Reel/Frame 030441/0229 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2010
From: KAVEY, NEIL B.
To: PROCOM ONE, INC.
Reel/Frame 024365/0528 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2007
From: ROGOWSKI, ROBERTA L.; DUBE, SUSAN E.; JOSCHELSON, PHILIP
To: SOMAXON PHARMACEUTICALS, INC.
Reel/Frame 020100/0436 →