Ultra low dose doxepin and methods of using the same to treat sleep disorders
View Patent ↗The invention relates to doxepin, pharmaceutically acceptable salts and prodrugs of doxepin; compositions containing the same, and the use of any of the aforementioned for the treatment of sleep disorders.
1. A method for treating insomnia comprising orally administering to a patient doxepin or a pharmaceutically acceptable salt thereof in a daily dosage ranging from about 0.0001 to about 0.2 milligrams without administering other insomnia or sleep medications.
2. The method of claim 1 , wherein the pharmaceutically acceptable salt of doxepin is the hydrochloride salt thereof.
3. The method of claim 1 , wherein the daily dosage ranges from about 0.001 to about 0.1 milligrams.
4. The method of claim 1 , wherein the daily dosage is about 0.01 to about 0.099 milligrams.
5. The method of claim 1 , wherein the insomnia is a non-chronic insomnia.
6. The method of claim 5 , wherein the non-chronic insomnia is a transient or a short term insomnia.
7. The method of claim 1 , wherein the insomnia is selected from the group consisting of onset insomnia and maintenance insomnia.
8. The method of claim 1 , wherein the patient is not suffering from depression.
9. The method of claim 1 , wherein the patient is suffering from depression.
10. A method of shortening the time required to achieve a maximum plasma concentration of doxepin in a patient receiving doxepin therapy comprising orally administering to the patient about 0.0001 milligrams to about 0.2 milligrams of doxepin in a pharmaceutical composition, wherein the doxepin is administered without food and without the administration of other insomnia or sleep medications.
11. A method of shortening the time required to achieve sleep onset comprising orally administering to the patient about 0.0001 milligrams to about 0.2 milligrams of doxepin in a pharmaceutical composition, wherein the doxepin is administered without food and without the administration of other insomnia or sleep medications.