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Claims for Patent: 9,107,898

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Claims for Patent: 9,107,898

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)
Application Number:13/492,559
Patent Claims: 1. A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8th hour of sleep in a patient in need thereof, comprising: identifying an elderly 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; and administering to the patient, prior to the start of the sleep period, doxepin or a pharmaceutically acceptable salt thereof in dosage that is effective to improve sleep maintenance insomnia by reducing fragmented sleep during the 8.sup.th hour of the sleep period, wherein the dosage is at least 3 mg, and up to 6 mg.

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. A method for treating sleep maintenance insomnia characterized by early awakenings during the 8.sup.th hour of sleep in a patient in need thereof, comprising: identifying an elderly 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; and reducing early awakenings during the 8th hour of the sleep period by administering to the patient, prior to the sleep period, a dosage of doxepin or the pharmaceutically acceptable salt thereof that is effective to improve sleep maintenance insomnia by reducing early awakenings during the 8.sup.th hour of the sleep period, wherein the dosage is least 3 mg, and up to 6 mg.

7. The method of claim 6, wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation.

8. The method of claim 6, wherein the sleep maintenance insomnia is a chronic insomnia.

9. The method of claim 6, wherein the sleep maintenance insomnia is a non-chronic insomnia.

10. The method of claim 6, wherein the sleep maintenance insomnia is a transient insomnia.
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