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Claims for Patent: 7,915,307

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Claims for Patent: 7,915,307

Title:Methods of improving the pharmacokinetics of doxepin
Abstract:Methods of improving the pharmacokinetics of doxepin in a patient.
Inventor(s): Casseday; Cara Baron (San Diego, CA), Ludington; Elizabeth (San Diego, CA), Skinner; Michael (San Diego, CA), Dube; Susan (Carlsbad, CA), Rogowski; Roberta L. (Rancho Santa Fe, CA), Jochelson; Philip (San Diego, CA), Mansbach; Robert (San Diego, CA)
Assignee: Somaxon Pharmaceuticals, Inc. (San Diego, CA)
Application Number:11/781,165
Patent Claims: 1. A method for providing sleep therapy comprising administering a 3 mg or a 6 mg dose of doxepin to an individual at least three hours after consuming a meal, thereby providing a faster onset of action and reducing next day residual effects.

2. The method of claim 1, wherein the administration comprises self administration by the individual.

3. The method of claim 1, wherein the doxepin is administered in a dose of 3 mg.

4. The method of claim 1, wherein the doxepin is administered in a dose of 6 mg.

5. The method of claim 1, wherein the doxepin is administered as a tablet, capsule or liquid.

6. The method of claim 5, wherein the doxepin is administered as a tablet.

7. The method of claim 1, wherein the doxepin is administered as a unit dosage form.

8. The method of claim 1, wherein the doxepin is administered as an oral dosage form.

9. A method of minimizing next day residual sedation caused by doxepin sleep therapy, comprising providing doses of 3 mg or 6 mg of doxepin to a patient and instructing the patient not to take the doxepin within three hours of consuming a meal.

10. The method of claim 9, comprising providing the patient with a 6 mg dose of doxepin.

11. The method of claim 9, comprising providing the patient with a 3 mg dose of doxepin.

12. The method of claim 9, wherein the doxepin is provided as a tablet, capsule or liquid.

13. The method of claim 12, wherein the doxepin is provided as a tablet.

14. The method of claim 9, wherein the doxepin is provided as a unit dosage form.

15. The method of claim 9, wherein the doxepin is provided as an oral dosage form.

16. In a method of treating insomnia with doxepin, wherein an insomnia patient receives a dosage of between 0.5 and 7 mg of doxepin, the improvement comprising altering the pharmacokinetics of doxepin by providing the patient with doxepin and providing instructions to take the doxepin at least three hours after a meal, such that upon taking the doxepin per said instructions, the pharmacokinetics are altered by decreasing the time to reach maximum plasma concentration (T.sub.max) in the patient, reducing the maximum plasma concentration (C.sub.max), and reducing the area under the curve (AUC) compared to administering the doxepin with food.

17. The method of claim 16, wherein the doxepin is provided in an amount of about 3 mg.

18. The method of claim 16, wherein the doxepin is provided in an amount of about 6 mg.

19. The method of claim 16, wherein the instructions further instruct the patient to take a dosage of 6 mg.

20. The method of claim 16, wherein the instructions further instruct the patient to take a dosage of 3 mg.

21. The method of claim 16, wherein the doxepin is provided as a tablet, capsule or liquid.

22. The method of claim 21, wherein the doxepin is provided as a tablet.

23. The method of claim 16, wherein the doxepin is provided as a unit dosage form.

24. The method of claim 16, wherein the doxepin is provided as an oral dosage form.
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