IP Library Granted Patent US 10,653,662
Granted Patent B2
US 10,653,662 · App. 16/363,128 · Granted May 19, 2020

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

Inventors: Roberta L. Rogowski (Rancho Santa Fe, CA); Susan E. Dubé (Carlsbad, CA); Philip Jochelson (San Diego, CA); Neil B. Kavey (Chappaqua, NY)
Assignees: Currax Pharmaceuticals LLC; ProCom One, Inc.
A61K31/335
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Quick Facts
Patent No.
US 10,653,662
App. No.
16/363,128
Granted
May 19, 2020
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 (18)

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 has difficulty staying asleep 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 has difficulty staying asleep during the final 45 minutes of said period.

7. The method of claim 1 , wherein the patient has difficulty staying asleep 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. The method of claim 1 , where in the patient is 18 to under 65 years of age.

13. The method of claim 12 , wherein the dosage of doxepin is about 3 mg or about 6 mg.

14. The method of claim 13 , wherein the dosage of doxepin is about 3 mg.

15. The method of claim 13 , where in the dosage of doxepin is about 6 mg.

16. The method of claim 1 , wherein the patient is 65 years of age or older.

17. The method of claim 16 , wherein the dosage of doxepin is about 3 mg.

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 →
Continuity (8)
Continuation 15864440 · Jan 8, 2018
Continuation 15344710 · Nov 7, 2016
Continuation 14804595 · Jul 21, 2015
Continuation 13492559 · Jun 8, 2012
Continuation 11804720 · May 18, 2007
Provisional Application 60801824 · May 19, 2006
Provisional Application 60833319 · Jul 25, 2006
Related Publication 20190216766A1 · Jul 18, 2019