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

• US 9,907,779 B2
• Filed: 10/03/2013
• Issued: 03/06/2018
• Est. Priority Date: 10/25/2006
• Status: Active Grant

• Current Assignee: Currax Pharmaceuticals, LLC (Currax Holdings USA, LLC)
• Original Assignee: Pernix Sleep, Inc. (Currax Holdings USA, LLC), Procom One Incorporated
• Inventors: Jochelson, Philip, Kavey, Neil B.
• Primary Examiner(s): Chernyshev, Olga N
• Application Number:
  US14/045,645
• Publication Number:
  US 20140107084A1
• Time in Patent Office: 1,615 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/335 having oxygen as the only ring hetero atom, e.g. fungichromin
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 31/4162 condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives

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

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.