Details for Patent: 9,498,462

Title:	Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders
Abstract:	The invention relates to use of the trans-(E) isomer or isomeric mixtures containing specified ratios of the trans-(E) and cis-(Z) 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:	Pernix Sleep, Inc. (Morristown, NJ) ProCom One, Inc. (San Marcos, TN)
Filing Date:	Dec 03, 2012
Application Number:	13/692,715
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, the method 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 88.3% to about 100.0% of the trans-(E) isomer or is 100% trans-(E) isomer. 2. The method of claim 1, wherein said geometric isomer mixture contains more than 90% of the trans-(E) isomer. 3. The method of claim 1, wherein said geometric isomer mixture contains more than 95% of the trans-(E) isomer. 4. The method of claim 1, wherein said geometric isomer mixture contains more than 98% of the trans-(E) isomer. 5. The method of claim 1, wherein said geometric isomer mixture contains more than 99% of the trans-(E) isomer. 6. The method of claim 1, wherein said geometric isomer mixture contains at least 99.5% or 99.9% of the trans-(E) isomer. 7. The method of claim 1, wherein said geometric isomer mixture contains 100.0% of the trans-(E) isomer. 8. The method of claim 1, wherein said geometric isomer mixture contains about 89% to about 99.9% of the trans-(E) isomer. 9. The method of claim 1, wherein the dosage is about 1 to about 6 milligrams. 10. 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, the method 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 88.3% to about 100.0% of the trans-(E) isomer or is 100% trans-(E) isomer. 11. The method of claim 10, wherein said geometric isomer mixture contains more than 90% of the trans-(E) isomer. 12. The method of claim 10, wherein said geometric isomer mixture contains more than 95% of the trans-(E) isomer. 13. The method of claim 10, wherein said geometric isomer mixture contains more than 98% of the trans-(E) isomer. 14. The method of claim 10, wherein said geometric isomer mixture contains more than 99% of the trans-(E) isomer. 15. The method of claim 10, wherein said geometric isomer mixture contains at least 99.5% or 99.9% of the trans-(E) isomer. 16. The method of claim 10, wherein said geometric isomer mixture contains 100.0% of the trans-(E) isomer. 17. The method of claim 10, wherein said geometric isomer mixture contains about 89% to about 99.9% of the trans-(E) isomer. 18. The method of claim 10, wherein the dosage is about 1 to about 6 milligrams.