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US 9,801,847 B2Granted
Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders
AssigneesPernix Sleep, Inc., ProCom One, Inc.
InventorsSusan E. Dubé, Neil B. Kavey
Life of this patent
Estimating the term…
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.
Claims20
A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8th hour of sleep, the method comprising:
- administering a dosage of doxepin or a pharmaceutically acceptable salt thereof to 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, wherein the dosage of doxepin or salt thereof is between about 0.1 and about 6 mg, 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, and wherein the dosage is administered prior to the start of the sleep period.
A method for treating sleep maintenance insomnia characterized by early awakenings during the 8th hour of sleep, the method comprising:
- administering a dosage of doxepin or a pharmaceutically acceptable salt thereof to 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, wherein the dosage of doxepin or salt thereof is between about 0.1 and about 6 mg, 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, and wherein the dosage is administered prior to the start of the sleep period.
Dependencies are inferred from the claim text.