Low-dose doxepin for treatment of sleep disorders in elderly patients

Abstract

Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.

1 . A method for treating insomnia in an elderly individual, comprising:
 identifying an individual over the age of 65 that is at risk of or suffering from next-day residual sedation resulting from a sleep medication;   administering to the individual an initial daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof;   evaluating whether a desired improvement in sleep and avoidance of next-day residual sedation is achieved by the individual at the initial dosage; and   increasing the dosage to 6 mg only if the desired improvement in sleep is not achieved.   
     
     
         2 . A method for treating insomnia in an elderly individual, comprising:
 identifying an individual over the age of 65 that is at risk of or suffering from confusion resulting from a sleep medication;   administering to the individual an initial daily dosage of 3 mg doxepin or a pharmaceutically acceptable salt thereof;   evaluating whether a desired improvement in sleep and avoidance of confusion is achieved by the individual at the initial dosage; and   increasing the dosage to 6 mg only if the desired improvement in sleep is not achieved.   
     
     
         3 . A method for treating insomnia characterized by fragmented sleep during the 8 th  hour of sleep in an elderly (65 years or older) patient in need thereof, comprising:
 identifying an elderly patient having a sleep maintenance 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 who is in need of avoiding confusion or next day residual sedation;   evaluating the importance to that patient of selecting a pharmaceutical agent to minimize the sleep maintenance disorder; and   avoiding the sleep maintenance disorder by reducing fragmented sleep in the 8 th  hour in said patient by:   selecting doxepin therapy for treating the patient based, at least in part, on its effect on the sleep maintenance disorder; and then administering to the patient, prior to the sleep period, doxepin or a pharmaceutically accept salt thereof at a beginning dosage of at least 3 mg, wherein the dosage is effective to improve sleep maintenance insomnia by reducing fragmented sleep during the 8 th  hour of the sleep period.   
     
     
         4 . The method of  claim 3 , further comprising identifying an elderly patient in need of minimizing confusion or next day residual sedation as a side effect of a pharmaceutical treatment. 
     
     
         5 . The method of  claim 3 , further comprising selecting the doxepin therapy based, at least in part, on its low incidence of confusion or next day residual sedation.