Methods of using low-dose doxepin for the improvement of sleep
Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
1. A method for treating insomnia, the method comprising:
administering an oral formulation comprising doxepin or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein the patient is aged 18 years to 64 years, wherein the oral formulation comprises one or more tablets or one or more capsules for a total dosage of doxepin of 6 mg, and wherein the oral formulation is administered prior to bedtime.
2. The method of claim 1 , wherein administering the oral formulation is effective to improve the insomnia while minimizing next day residual sedation.
3. The method of claim 1 , wherein the oral formulation comprises one or more tablets.
4. The method of claim 3 , wherein each tablet comprises a dosage of doxepin of 3 mg.
5. The method of claim 1 , wherein the oral formulation comprises one or more capsules.
6. The method of claim 1 , wherein the patient has difficulty staying asleep during the final 45 minutes of an 8-hour sleep period.
7. The method of claim 1 , wherein the patient has difficulty staying asleep during the final 30 minutes of an 8-hour sleep period.
8. The method of claim 1 , wherein administering the formulation is effective to decrease wake time after sleep (WTAS).
9. The method of claim 1 , wherein administering the formulation is effective to decrease wake after sleep onset (WASO).
10. The method of claim 1 , wherein administering the formulation is effective to decrease latency to sleep onset (LSO).
11. The method of claim 1 , wherein administering the formulation is effective to increase sleep efficiency (SE).
12. The method of claim 1 , wherein administering the formulation is effective to increase total sleep time (TST).
13. The method of claim 1 , further comprising administering an oral formulation comprising doxepin or a pharmaceutically acceptable salt thereof to a second patient in need thereof, wherein the second patient is aged 65 years or older, wherein the oral formulation comprises one or more tablets or one or more capsules for a total dosage of doxepin of 3 mg, and wherein the oral formulation is administered prior to bedtime.