# US 11,110,074 B2 · Methods of improving the pharmacokinetics of doxepin

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- Number: US 11,110,074 B2
- Document ID: US11110074B2
- Status: Granted
- Kind: B2
- Application number: 16/876,492
- Filed: 2020-05-18
- Published: 2020-09-03
- Granted: 2021-09-07
- Earliest claimed: 2006-07-20
- Assignees: Currax Pharmaceuticals LLC
- Applicants: Currax Pharmaceuticals LLC
- Inventors: Cara Baron Casseday; Elizabeth Ludington; Michael Skinner; Susan E. Dubé; Roberta L. Rogowski; Philip Jochelson; Robert Mansbach
- Web page: https://patentgrep.com/patent/US11110074B2

## CPC

- A61K 31/335: having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Methods of improving the pharmacokinetics of doxepin in a patient.

## Claims

### Claim 1

A method of treating insomnia, the method comprising:
administering between about 0.5 mg and 7 mg doxepin to a patient in need thereof, wherein the doxepin is administered at least 3 hours after consuming a meal to provide faster onset of action.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The method of claim 1, wherein the doxepin helps the patient fall asleep.

### Claim 8 (depends on 1)

The method of claim 1, wherein the doxepin helps the patient stay asleep.

### Claim 9 (depends on 1)

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 (AUK) compared to administration of doxepin to a group of fasted patients.

### Claim 10 (depends on 9)

The method of claim 9, wherein the increase in AUC is about 41%.

### Claim 11 (depends on 1)

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 (Cmax) compared to administration of doxepin to a group of fasted patients.

### Claim 12 (depends on 11)

Claim 11, wherein the increase in Cmax is about 15%.

### Claim 13 (depends on 1)

The method of claim 1, wherein the doxepin is administered within about one hour of bedtime.

### Claim 14 (depends on 1)

The method of claim 1, wherein the doxepin is administered as doxepin hydrochloride.

### Claim 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 at least 3 hours after consuming a meal to provide faster onset of action, wherein administration of doxepin to a group of patients after a 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 (Cmax) of doxepin; or
a delay in median time to reach maximum plasma concentration (Tmax) of doxepin.

### Claim 16 (depends on 15)

The method of claim 15, wherein the increase in AUC is about 41%.

### Claim 17 (depends on 15)

The method of claim 15, wherein the increase in maximum plasma concentration (Cmax) is about 15%.

### Claim 18 (depends on 15)

The method of claim 15, wherein the a delay in median time to reach maximum plasma concentration (Tmax) is about 3 hours.

### Claim 19 (depends on 15)

The method of claim 15, wherein administration of doxepin to a group of fasted patients provides:
an increase in area under the curve (AUC) is about 41%;
an increase in maximum plasma concentration (Cmax) is about 15%; or
a delay in median time to reach maximum plasma concentration (Tmax) is about 3 hours.