Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders

摘要

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.

主权项

1. A method for the treatment of a patient suffering from sleep maintenance insomnia characterized by fragmented sleep during the 8th 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 8th 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.