Details for Patent: 9,463,181

Title:	Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders
Abstract:	The invention relates to use of the cis-(Z) isomer or isomeric mixtures containing specified ratios of the cis-(Z) and trans-(E) isomers of doxepin, metabolites of doxepin, pharmaceutically-acceptable salts of doxepin and prodrugs of the same; compositions containing the same, for the treatment of sleep disorders.
Inventor(s):	Dube; Susan E. (Carlsbad, CA), Kavey; Neil B. (Chappaqua, NY)
Assignee:	Pemix Sleep, Inc. (Morristown, NJ) ProCom One, Inc. (San Marcos, TX)
Filing Date:	Dec 03, 2012
Application Number:	13/692,415
Claims:	1. A method for the treatment of a patient suffering from sleep maintenance insomnia characterized by fragmented sleep during the 8.sup.th hour of sleep, comprising: identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences fragmented sleep during the final 60 minutes of said period; and administering to said patient, prior to the start of the sleep period, a dosage of doxepin or a pharmaceutically-acceptable salt thereof that is effective to improve sleep maintenance insomnia by reducing early awakenings during the 8.sup.th hour of the sleep period, wherein the dosage ranges from about 0.1 to about 20 milligrams, wherein the doxepin or salt thereof is a geometric isomer mixture containing about 18.2% to about 100.0% of the cis-(Z) isomer or is 100% cis-(Z) isomer. 2. The method of claim 1, wherein said geometric isomer mixture contains more than 20% of the cis-(Z) isomer. 3. The method of claim 1, wherein said geometric isomer mixture contains more than 50% of the cis-(Z) isomer. 4. The method of claim 1, wherein said geometric isomer mixture contains more than 90% of the cis-(Z) isomer. 5. The method of claim 1, wherein said geometric isomer mixture contains more than 95% of the cis-(Z) isomer. 6. The method of claim 1, wherein said geometric isomer mixture contains about 20% to about 99.9% of the cis-(Z) isomer. 7. The method of claim 1, wherein the dosage is about 1 to about 6 milligrams. 8. A method for the treatment of a patient suffering from sleep maintenance insomnia characterized by early awakenings during the 8.sup.th hour of sleep, comprising: identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences early awakenings during the final 60 minutes of said period; and administering to said patient, prior to the start of the sleep period, a dosage of doxepin or a pharmaceutically-acceptable salt thereof that is effective to improve sleep maintenance insomnia by reducing early awakenings during the 8.sup.th hour of the sleep period, wherein the dosage ranges from about 0.1 to about 20 milligrams, wherein the doxepin or salt thereof is a geometric isomer mixture containing about 18.2% to about 100.0% of the cis-(Z) isomer or is 100% cis-(Z) isomer. 9. The method of claim 8, wherein said geometric isomer mixture contains more than 20% of the cis-(Z) isomer. 10. The method of claim 8, wherein said geometric isomer mixture contains more than 50% of the cis-(Z) isomer. 11. The method of claim 8, wherein said geometric isomer mixture contains more than 90% of the cis-(Z) isomer. 12. The method of claim 8, wherein said geometric isomer mixture contains more than 95% of the cis-(Z) isomer. 13. The method of claim 8, wherein said geometric isomer mixture contains about 20% to about 99.9% of the cis-(Z) isomer. 14. The method of claim 8, wherein the dosage is about 1 to about 6 milligrams.