IP Library Patent Application 18826980
Patent Application
App. No. 18/826,980

Methods Of Using Low-Dose Doxepin For The Improvement Of Sleep

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Quick Facts
Patent No.
US None
App. No.
18/826,980
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).

Claims (14)

1 . A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8 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 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 th hour of the sleep period, wherein the dosage is at least 3 mg, 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 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 8 th 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 th hour of the sleep period, wherein the dosage is least 3 mg, 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.