Methods Of Improving The Pharmacokinetics Of Doxepin

Abstract

Methods of improving the pharmacokinetics of doxepin in a patient.

We claim: 
     
         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.