Claims for Patent: 12,083,090

Summary for Patent: 12,083,090

Title:	Methods of using low-dose doxepin for the improvement of sleep
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).
Inventor(s):	Roberta L. Rogowski, Susan E. Dubé, Philip Jochelson, Neil B. Kavey
Assignee:	PROCOM ONE Inc , Currax Pharmaceuticals LLC
Application Number:	US16/876,446
Patent Claims:	1. A method for treating insomnia, the method comprising: administering an oral formulation comprising doxepin or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein the patient is aged 18 years to 64 years, wherein the oral formulation comprises one or more tablets or one or more capsules for a total dosage of doxepin of 6 mg, and wherein the oral formulation is administered prior to bedtime. 2. The method of claim 1, wherein administering 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 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 an 8-hour sleep period. 7. The method of claim 1, wherein the patient has difficulty staying asleep during the final 30 minutes of an 8-hour sleep period. 8. The method of claim 1, wherein administering the formulation is effective to decrease wake time after sleep (WTAS). 9. The method of claim 1, wherein administering the formulation is effective to decrease wake after sleep onset (WASO). 10. The method of claim 1, wherein administering the formulation is effective to decrease latency to sleep onset (LSO). 11. The method of claim 1, wherein administering the formulation is effective to increase sleep efficiency (SE). 12. The method of claim 1, wherein administering the formulation is effective to increase total sleep time (TST). 13. The method of claim 1, further comprising administering an oral formulation comprising doxepin or a pharmaceutically acceptable salt thereof to a second patient in need thereof, wherein the second patient is aged 65 years or older, wherein the oral formulation comprises one or more tablets or one or more capsules for a total dosage of doxepin of 3 mg, and wherein the oral formulation is administered prior to bedtime.