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.

Description

RELATED APPLICATION[0001]This application is a continuation of U.S. patent application Ser. No. 11 / 804,722, filed May 18, 2007, which claims priority under 35 U.S.C. 119 to U.S. Provisional Application No. 60 / 801,823, filed May 19, 2006, the entire contents of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to the use of ultra-low doses of doxepin (1-3 milligrams) for treatment of sleep disorders, particularly insomnia, in individuals 65 years or older.BACKGROUND OF THE INVENTION[0003]Sleep is essential for health and quality of life. Insomnia is a growing health problem in the United States. It is believed that more than 10-15 million people suffer from chronic insomnia and up to an additional 70 million people suffer from some form of insomnia each year. Insomnia is a condition characterized by difficulty falling asleep (sleep onset), waking frequently during the night (fragmented sleep), waking too early (premature final awaken...

AI Technical Summary

Benefits of technology

[0016]Some embodiments relate to methods for treating a sleep disorder, which methods can include identifying a patient over the age of 65 who is susceptible to one or more of the following side effects caused by sleep medication: nervous system side effects; psychiatric side effects; respiratory side effects; skin side effects; musculoskeletal side effects; and connective tissue side effects; and administering doxepin, pharmaceutically acceptable salts of the same, or prodrugs of the same to the patient. Preferably, the dosage can be about 1 mg to 6 mg. The identifying step can include identifying a patient who is susceptible to central nervous system side effects caused by sleep medication, and the central nervous system side effect can be, for example, at least one of somnolence, headache, dizziness, lethargy, and balance disorder. Also, the identifying step can include identifying a patient who is susceptible to psychiatric side effects caused by sleep medication. The psychiatric side effect can be, for example, at least one of anxiety, confusion, and abnormal dreams. In some aspects, the dose can be about 0.5 mg to about 10 mg, for example.

Problems solved by technology

Insomnia is a growing health problem in the United States.

Sleep maintenance difficulty is a significant problem for many primary care patients with chronic insomnia, including depressed patients, medically ill populations, especially those with pain symptoms, and the elderly.

In elderly populations (i.e., patients over the age of 65 years), there are several sleep disorders that are often difficult to satisfactorily address or manage with available medications.

Although some conventional medications can extend sleep time, they often fail to satisfactorily address the issue.

In some instances, sleep is not extended into the final (eighth) hour of the sleep period, so that the patient still prematurely terminate sleep prior to the end of the sleep period, particularly during the last hour of an 8-hour period.

If the dosage of medication is sufficient to extend sleep into or through the eighth hour of the sleep period, the patients often suffer from post-sleep amnesia or memory loss, or experience sedation after awakening that can interfere with normal activities, including driving, operation of other equipment, concentration, and normal mental function.

Other elderly patients suffer from fragmented sleep in the final hour of sleep, exhibiting disturbed sleep patterns that interfere with restful sleep.

Although fragmented sleep can be facilitated by a number of commercially-available sleep medications, many of those do not adequately improve sleep efficiency in the last hour of an 8-hour sleep period.

As with treatments for terminal insomnia, if the dosage is increased sufficiently to improve sleep efficiency in the last hour of the sleep period, the patient may experience post-sleep sedation that interferes with normal activities.

Older patients are at particular risk for common side effects of conventional insomnia therapy, including next-day amnesia or memory loss, next-day sedation, and drug-drug interactions between sleep medications and other medications they may be taking.

Two over-the-counter antihistamines often used for treatment of insomnia, diphenhydramine and doxylamine, have substantial anticholinergic properties, with the potential to cause numerous side effects, especially among older patients.

As a result, it would be expected that dosages of doxepin that are sufficient to address terminal insomnia or last-hour fragmented sleep in the elderly would also cause post-sleep sedation or other undesirable adverse effects.

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