IP Library Granted Patent US 9,907,779
Granted Patent B2
US 9,907,779 · App. 14/045,645 · Granted Mar 6, 2018

Ultra low dose doxepin and methods of using the same to treat sleep disorders

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Quick Facts
Patent No.
US 9,907,779
App. No.
14/045,645
Granted
Mar 6, 2018
Kind
B2
Abstract

The invention relates to doxepin, pharmaceutically acceptable salts and prodrugs of doxepin; compositions containing the same, and the use of any of the aforementioned for the treatment of sleep disorders.

Claims (11)

1. A method for treating insomnia comprising orally administering to a patient doxepin or a pharmaceutically acceptable salt thereof in a daily dosage ranging from about 0.0001 to about 0.2 milligrams without administering other insomnia or sleep medications.

2. The method of claim 1 , wherein the pharmaceutically acceptable salt of doxepin is the hydrochloride salt thereof.

3. The method of claim 1 , wherein the daily dosage ranges from about 0.001 to about 0.1 milligrams.

4. The method of claim 1 , wherein the daily dosage is about 0.01 to about 0.099 milligrams.

5. The method of claim 1 , wherein the insomnia is a non-chronic insomnia.

6. The method of claim 5 , wherein the non-chronic insomnia is a transient or a short term insomnia.

7. The method of claim 1 , wherein the insomnia is selected from the group consisting of onset insomnia and maintenance insomnia.

8. The method of claim 1 , wherein the patient is not suffering from depression.

9. The method of claim 1 , wherein the patient is suffering from depression.

10. A method of shortening the time required to achieve a maximum plasma concentration of doxepin in a patient receiving doxepin therapy comprising orally administering to the patient about 0.0001 milligrams to about 0.2 milligrams of doxepin in a pharmaceutical composition, wherein the doxepin is administered without food and without the administration of other insomnia or sleep medications.

11. A method of shortening the time required to achieve sleep onset comprising orally administering to the patient about 0.0001 milligrams to about 0.2 milligrams of doxepin in a pharmaceutical composition, wherein the doxepin is administered without food and without the administration of other insomnia or sleep medications.

Assignments (4)
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 →
MERGER Recorded Jun 6, 2016
From: SOMAXON PHARMACEUTICALS, INC.
To: PERNIX SLEEP, INC.
Reel/Frame 038813/0079 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2014
From: KAVEY, NEIL B.
To: PROCOM ONE, INC.
Reel/Frame 033394/0993 →