IP Library › Patent Application 13007334
Patent Application
App. No. 13/007,334

METHODS OF IMPROVING THE PHARMACOKINETICS OF DOXEPIN

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
13/007,334
Abstract

Methods of improving the pharmacokinetics of doxepin in a patient.

Claims (27)

1 . A method of treating a sleep disorder, comprising:

selecting a patient with insomnia;

providing between about 0.5 mg and 7 mg doxepin to the patient; and

administering the doxepin to the patient without food.

2 . The method of claim 1 , wherein the administering without food comprises administering the doxepin at least about 30 minutes after consuming food.

3 . The method of claim 1 , wherein administering without food comprises administering the doxepin at about 1 hour prior to consuming food.

4 . The method of claim 1 , wherein the doxepin is provided in an amount of about 3 milligrams.

5 . The method of claim 1 wherein the doxepin is provided in an amount of about 6 milligrams.

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

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

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

9 . 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 altering the pharmacokinetics of doxepin by providing the patient with instructions to take the doxepin without food, and administering the doxepin without food, thereby decreasing the time to reach maximum plasma concentration (T max ) in the patient, reducing C max , and reducing the area under the curve (AUC compared to administering the doxepin with food.

10 . The method of claim 9 , wherein decreasing the time to reach maximum plasma concentration (T max ) in the patient, reducing C max , and/or reducing the area under the curve (AUC) shortens the time required to achieve sleep onset and/or reduces next-day sedation effects.

11 . The method of claim 9 , wherein the instructions indicate a dosage of 6 milligrams.

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

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

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

15 . A method of treating a sleep disorder with doxepin while achieving a desired alteration in doxepin pharmacokinetics, comprising:

identifying a patient with insomnia;

providing between 0.5 mg and 7 mg doxepin to the patient;

instructing the patient to take the doxepin without food; and

administering the doxepin to the patient without food, thereby decreasing the time to reach a maximum plasma concentration (T max ) in the patient, reducing C max , and reducing the area under the curve (AUC), compared to administering the doxepin with food.

16 . The method of claim 15 , decreasing the time to reach maximum plasma concentration (T max ) in the patient, reducing C max , and/or reducing the area under the curve (AUC) shortens the time required to achieve sleep onset and/or reduces next-day sedation effects.

17 . The method of claim 15 , wherein the therapeutically effective amount is about 6 milligrams.

18 . The method of claim 15 , wherein the doxepin is provided as a tablet, capsule or liquid.

19 . The method of claim 15 , wherein the doxepin is provided as a unit dosage form.

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