Details for Patent: 9,486,437
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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): | Rogowski; Roberta L. (Rancho Santa Fe, CA), Dube; Susan E. (Carlsbad, CA), Jochelson; Philip (San Diego, CA), Kavey; Neil B. (Chappaqua, NY) |
Assignee: | Pernix Sleep, Inc. (Morristown, NJ) ProCom One, Inc. (San Marcos, TX) |
Filing Date: | Jul 21, 2015 |
Application Number: | 14/804,595 |
Claims: | 1. A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8.sup.th hour of sleep, the method comprising: administering a dosage of 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 experiences fragmented sleep during the final 60 minutes of said period, wherein the dosage of doxepin is between about 0.5 and about 6 mg and is administered prior to the start of the sleep period. 2. The method of claim 1, wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation. 3. The method of claim 1, wherein the sleep maintenance insomnia is a chronic insomnia. 4. The method of claim 1, wherein the sleep maintenance insomnia is a non-chronic insomnia. 5. The method of claim 1, wherein the sleep maintenance insomnia is a transient insomnia. 6. The method of claim 1, wherein the patient experiences a sleep period that terminates during the final 45 minutes of said period. 7. The method of claim 1, wherein the patient experiences a sleep period that terminates 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. A method for treating sleep maintenance insomnia characterized by early awakenings during the 8.sup.th hour of sleep, the method comprising: administering a dosage of 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 experiences early awakenings during the final 60 minutes of said period, wherein the dosage of doxepin is between about 0.5 and about 6 mg and is administered prior to the start of the sleep period. 12. The method of claim 11, wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation. 13. The method of claim 11, wherein the sleep maintenance insomnia is a chronic insomnia. 14. The method of claim 11, wherein the sleep maintenance insomnia is a non-chronic insomnia. 15. The method of claim 11, wherein the sleep maintenance insomnia is a transient insomnia. 16. The method of claim 11, wherein the dosage of doxepin is about 1 mg. 17. The method of claim 11, wherein the dosage of doxepin is about 3 mg. 18. The method of claim 11, wherein the dosage of doxepin is about 6 mg. |