Methods of improving the pharmacokinetics of doxepin
View Patent ↗Methods of improving the pharmacokinetics of doxepin in a patient.
1. A method of treating insomnia in a patient in need thereof, the method comprising:
administering between about 0.5 mg and about 7 mg doxepin to the patient, wherein the doxepin is administered at least 3 hours after consuming a meal to provide faster onset of action and minimize potential for next day sedation effects.
2. The method of claim 1 , wherein the doxepin is administered in an amount of about 3 milligrams.
3. The method of claim 1 wherein the doxepin is administered in an amount of about 6 milligrams.
4. The method of claim 1 wherein the doxepin is administered as a tablet, capsule or liquid.
5. The method of claim 1 , wherein the doxepin is administered as a unit dosage form.
6. The method of claim 1 , wherein the doxepin is administered as an oral dosage form.
7. The method of claim 1 , wherein the doxepin helps the patient fall asleep.
8. The method of claim 1 , wherein the doxepin helps the patient stay asleep.
9. The method of claim 1 , wherein administration of doxepin to a group of patients after a high fat meal provides an increase in area under the curve (AUC) compared to administration of doxepin to a group of fasted patients.
10. The method of claim 9 , wherein the increase in AUC is about 41%.
11. The method of claim 1 , wherein administration of doxepin to a group of patients after a high fat meal provides an increase in maximum plasma concentration (C max ) compared to administration of doxepin to a group of fasted patients.
12. The method of claim 11 , wherein the increase in C max is about 15%.
13. The method of claim 1 , wherein the doxepin is administered within about one hour of bedtime.
14. The method of claim 1 , wherein the doxepin is administered as doxepin hydrochloride.
15. A method of treating insomnia in a patient in need thereof, the method comprising:
administering between about 0.5 mg and about 7 mg doxepin to the patient, wherein the doxepin is administered at least 3 hours after consuming a meal, wherein administration of doxepin to a group of patients after a high fat meal compared to administration of doxepin to a group of fasted patients provides:
an increase in area under the curve (AUC) of doxepin;
an increase in maximum plasma concentration (C max ) of doxepin; or
a delay in median time to reach maximum plasma concentration (T max ) of doxepin.
16. The method of claim 15 , wherein the increase in AUC is about 41%.
17. The method of claim 15 , wherein the increase in C max is about 15%.
18. The method of claim 15 , wherein the delay in T max is about 3 hours.
19. The method of claim 15 , wherein administration of doxepin to a group of patients after a high fat meal compared to administration of doxepin to a group of fasted patients provides:
an increase in AUC of about 41%;
an increase in C max of about 15%; and
a delay in T max of about 3 hours.