Claims for Patent: 11,234,954

Summary for Patent: 11,234,954

Title:	Low-dose doxepin for treatment of sleep disorders in elderly patients
Abstract:	Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.
Inventor(s):	Rogowski; Roberta L. (Rancho Santa Fe, CA), Dube; Susan Ellen (Carlsbad, CA), Jochelson; Philip (San Diego, CA), Kavey; Neil Barton (Chappaqua, NY)
Assignee:	Currax Pharmaceuticals LLC (Brentwood, TN)
Application Number:	14/789,911
Patent Claims:	1. A method for treating insomnia characterized by difficulties with sleep maintenance, the method comprising: identifying a first adult patient 18 to 64 years of age in need of treatment of insomnia; identifying a second adult patient 65 years of age or older in need of treatment of insomnia who is susceptible to one or more side effects caused by a sleep medication, the side effects comprising one or more of nervous system side effects, psychiatric side effects, respiratory side effects, skin side effects, musculoskeletal side effects, connective tissue side effects or central nervous system side effects; recognizing that a daily dosage of 6 mg doxepin or a pharmaceutically acceptable salt thereof provides a statistically significant decrease in wake time during sleep (WTDS) in a group of adult patients 18 to 64 years of age but does not provide a statistically significant effect on next-day residual sedation in a group of adult patients 18 to 64 years of age; administering to the first adult patient a daily dosage of 6 mg doxepin or a pharmaceutically acceptable salt thereof; recognizing that a daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof provides statistically significant decrease in wake time during sleep (WTDS) and in wake after sleep onset (WASO) in a group of elderly patients 65 years of age or older and does not provide a statistically significant effect on next-day residual sedation in a group of elderly patients 65 years of age or older; administering to the second adult patient an initial daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof; evaluating whether a desired improvement in sleep is achieved by the second adult patient at the initial daily dosage; and increasing the daily dosage of the second adult patient to 6 mg only if the desired improvement in sleep is not achieved, wherein the initial daily dosage of 3 mg is administered to the second adult patient for at least 15 consecutive days. 2. The method of claim 1, wherein the initial daily dosage of 3 mg is administered to the second adult patient for up to 85 days. 3. A method for treating insomnia, the method comprising: identifying a first adult patient 18 to 64 years of age in need of treatment of insomnia; identifying a second adult patient 65 years of age or older in need of treatment of insomnia who is susceptible to one or more side effects caused by a sleep medication, the side effects comprising one or more of nervous system side effects, psychiatric side effects, respiratory side effects, skin side effects, musculoskeletal side effects, connective tissue side effects or central nervous system side effects; administering to the first adult patient a daily dosage of 6 mg doxepin or a pharmaceutically acceptable salt thereof; and administering to the second adult patient a daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof, wherein the daily dosage of 3 mg provides a statistically significant reduction in latency to persistent sleep (LPS) in a group of elderly patients 65 years of age or older, and wherein the daily dosage of 3 mg is administered to the second adult patient for at least 15 consecutive days. 4. The method of claim 3, wherein the daily dosage of 3 mg is administered to the second adult patient for at least 15 days. 5. The method of claim 3, wherein the daily dosage of 3 mg is administered to the second adult patient for up to 85 days. 6. The method of claim 3, further comprising evaluating whether a desired improvement in sleep is achieved by the second adult patient at the daily dosage of 3 mg and increasing the daily dosage of the second adult patient to 6 mg if the desired improvement in sleep is not achieved. 7. The method of claim 3, wherein administration of a daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof to a group of adult patients 18 to 64 years of age does not provide a statistically significant reduction in latency to persistent sleep. 8. The method of claim 3, wherein the insomnia comprises insomnia characterized by difficulties with sleep maintenance. 9. The method of claim 3, wherein the daily dosage of 3 mg does not provide a statistically significant effect on next-day residual sedation in a group of elderly patients 65 years of age or older. 10. The method of claim 3, wherein the daily dosage of 6 mg does not provide a statistically significant effect on next-day residual sedation in a group of adult patients 18 to 64 years of age. 11. The method of claim 1, further comprising recognizing that a daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof provides a statistically significant reduction in latency to persistent sleep (LPS) in a group of elderly patients 65 years of age or older. 12. The method of claim 1, wherein the central nervous side effects comprises at least one of a somnolence, headache, dizziness, lethargy or balance disorder. 13. The method of claim 1, wherein the psychiatric side effect comprises at least one of anxiety, confusion and abnormal dreams. 14. The method of claim 1, wherein the psychiatric side effect comprises anxiety or abnormal dreams. 15. The method of claim 3, wherein the central nervous side effect comprises at least one of a somnolence, headache, dizziness, lethargy or balance disorder. 16. The method of claim 3, wherein the psychiatric side effect comprises at least one of anxiety, confusion and abnormal dreams. 17. The method of claim 3, wherein the psychiatric side effect comprises anxiety or abnormal dreams. 18. A method for treating chronic insomnia, the method comprising: identifying a first adult patient 18 to 64 years of age in need of treatment of insomnia; identifying a second adult patient 65 years of age or older in need of treatment of insomnia who is susceptible to one or more side effects caused by a sleep medication, the side effects comprising one or more of nervous system side effects, psychiatric side effects, respiratory side effects, skin side effects, musculoskeletal side effects, connective tissue side effects or central nervous system side effects; administering to the first adult patient a daily dosage of 6 mg doxepin or a pharmaceutically acceptable salt thereof; and administering to the second adult patient a daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof for up to 85 days, wherein the daily dosage of 3 mg provides a statistically significant reduction in latency to persistent sleep (LPS) in a group of elderly patients 65 years of age or older, and wherein the daily dosage of 3 mg is administered to the second adult patient for at least 15 consecutive days.