Claims for Patent: 11,096,920

Summary for Patent: 11,096,920

Title:	Low-dose doxepin formulations and methods of making and using the same
Abstract:	The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Inventor(s):	Schioppi; Luigi (Escondido, CA), Dorsey; Brian Talmadge (Encinitas, CA), Skinner; Michael (San Diego, CA), Carter; John (Keswick, CA), Mansbach; Robert (San Diego, CA), Jochelson; Philip (San Diego, CA), Rogowski; Roberta L. (Rancho Santa Fe, CA), Casseday; Cara Baron (San Diego, CA), Perry; Meredith (El Cajon, CA), Knox; Bryan (San Diego, CA)
Assignee:	Currax Pharmaceuticals LLC (Morristown, NJ)
Application Number:	16/779,901
Patent Claims:	1. A method of treating insomnia, the method comprises administering to a patient in need thereof a pharmaceutical composition comprising about 0.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and about 80% to about 99.8% w/w silicified microcrystalline cellulose. 2. The method of claim 1, wherein administering the composition provides a plasma concentration of at least 0.05 ng/mL doxepin within a time frame of not more than about 90 minutes. 3. The method of claim 1, wherein the composition further comprises about 0.1 to about 1.5% w/w colloidal silicon dioxide. 4. The method of claim 1, wherein the composition further comprises about 0.25 to about 1.5% w/w magnesium stearate. 5. The method of claim 1, wherein the composition comprises about 0.8 to about 2 mg of doxepin or a pharmaceutically acceptable salt thereof. 6. The method of claim 1, wherein the composition comprises about 2.5 to about 4 mg of doxepin or a pharmaceutically acceptable salt thereof. 7. The method of claim 1, wherein the composition comprises about 3 mg of doxepin or a pharmaceutically acceptable salt thereof. 8. The method of claim 1, wherein the composition comprises about 5.5 to about 7 mg of doxepin or a pharmaceutically acceptable salt thereof. 9. The method of claim 1, wherein the composition comprises about 6 mg of doxepin or a pharmaceutically acceptable salt thereof. 10. The method of claim 1, wherein the composition further comprises one or more of colloidal silicon dioxide or magnesium stearate. 11. The method of claim 1, wherein the insomnia is a chronic insomnia. 12. The method of claim 1, wherein the insomnia is a non-chronic insomnia. 13. The method of claim 1, wherein the insomnia is a non-chronic insomnia. 14. The method of claim 1, wherein the patient suffers from difficulties in sleep onset. 15. The method of claim 1, wherein the patient suffers from difficulties in sleep maintenance. 16. The method of claim 1, wherein the patient suffers from difficulties in sleep duration. 17. The method of claim 1, wherein the patient suffers from difficulties in sleep efficiency. 18. The method of claim 1, wherein the patient suffers from difficulties in premature early-morning awakening. 19. The method of claim 1, wherein the composition comprises a tablet. 20. The method of claim 1, wherein administering the composition provides a plasma concentration of at least 0.1 ng/mL doxepin within a time frame of not more than about 60 minutes.