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Claims for Patent: 8,513,299

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Claims for Patent: 8,513,299

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)
Assignee: Pernix Sleep, Inc. (The Woodlands, TX) Procom One, Inc. (San Marcos, TX)
Application Number:11/804,720
Patent Claims: 1. A method for reducing or preventing early awakenings in a patient in need thereof, comprising: identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences a sleep period that terminates during the final 60 minutes of said period; and providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 and 6 mg that is effective to lengthen the sleep period.

2. The method of claim 1, wherein the patient is identified as experiencing a sleep period that terminates during the final 45 minutes of said period.

3. The method of claim 1, wherein the patient is identified as experiencing a sleep period that terminates during the final 30 minutes of said period.

4. The method of claim 1, wherein the dosage is sufficient to lengthen the sleep period to terminate during the 8.sup.th hour of said period.

5. The method of claim 1, wherein the sleep period is lengthened to terminate after hour 7.5 of said period.

6. The method of claim 1, wherein the patient is additionally identified as in need of reducing wake time after sleep.

7. The method of claim 1, wherein the patient suffers from chronic or non-chronic insomnia.

8. The method of claim 7, wherein the patient suffers from transient insomnia.

9. A method for decreasing fragmented sleep in the 8th hour of a sleep period for a patient, comprising: identifying a patient suffering from fragmented sleep during the 8th hour of a sleep period; and providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 mg and 6 mg.

10. The method of claim 9, wherein said dosage of doxepin is about 1 mg, 3 mg or 6 mg.

11. The method of claim 10, wherein said dosage of doxepin is about 0.5 mg.

12. The method of claim 10, wherein said dosage of doxepin is about 1 mg.

13. The method of claim 10, wherein said dosage of doxepin is about 3 mg.

14. The method of claim 10, wherein said dosage of doxepin is about 6 mg.

15. The method of claim 9, wherein said patient suffers from chronic or non-chronic insomnia.

16. The method of claim 15, wherein the patient suffers from transient insomnia.

17. The method of claim 1, wherein said dosage of doxepin is about 1 mg, 3 mg or 6 mg.

18. The method of claim 1, wherein said dosage of doxepin is about 0.5 mg.

19. The method of claim 1, wherein said dosage of doxepin is about 1 mg.

20. The method of claim 1, wherein said dosage of doxepin is about 3 mg.

21. The method of claim 1, wherein said dosage of doxepin is about 6 mg.

22. A method for reducing early awakenings in a patient in need thereof, comprising: identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences a sleep period that terminates during the final 60 minutes of said period; and providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 and 6 mg.
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