IP Library Granted Patent US 9,107,898
Granted Patent B2
US 9,107,898 · App. 13/492,559 · Granted Aug 18, 2015

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

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Quick Facts
Patent No.
US 9,107,898
App. No.
13/492,559
Granted
Aug 18, 2015
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 (14)

1. A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8th hour of sleep in a patient in need thereof, comprising:

identifying an elderly 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; and

administering to the patient, prior to the start of the sleep period, doxepin or a pharmaceutically acceptable salt thereof in dosage that is effective to improve sleep maintenance insomnia by reducing fragmented sleep during the 8 th hour of the sleep period, wherein the dosage is at least 3 mg, and up to 6 mg.

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. A method for treating sleep maintenance insomnia characterized by early awakenings during the 8 th hour of sleep in a patient in need thereof, comprising:

identifying an elderly 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; and

reducing early awakenings during the 8th hour of the sleep period by administering to the patient, prior to the sleep period, a dosage of doxepin or the pharmaceutically acceptable salt thereof that is effective to improve sleep maintenance insomnia by reducing early awakenings during the 8 th hour of the sleep period, wherein the dosage is least 3 mg, and up to 6 mg.

7. The method of claim 6 , wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation.

8. The method of claim 6 , wherein the sleep maintenance insomnia is a chronic insomnia.

9. The method of claim 6 , wherein the sleep maintenance insomnia is a non-chronic insomnia.

10. The method of claim 6 , wherein the sleep maintenance insomnia is a transient insomnia.

Assignments (9)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2014
From: ROGOWSKI, ROBERTA L.; DUBE, SUSAN E.; JOCHELSON, PHILLIP
To: SOMAXON PHARMACEUTICALS, INC.
Reel/Frame 032791/0680 →
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: SOMAXON PHARMACEUTICALS, INC.
To: PERNIX THERAPEUTICS HOLDINGS, INC.
Reel/Frame 032118/0272 →
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 →
SECURITY AGREEMENT Recorded May 17, 2013
From: PERNIX SLEEP, INC.
To: MIDCAP FINANCIAL, LLC
Reel/Frame 030441/0229 →