You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for Patent: 9,486,437


✉ Email this page to a colleague

« Back to Dashboard


Title:Methods of using low-dose doxepin for the improvement of sleep
Abstract: 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).
Inventor(s): Rogowski; Roberta L. (Rancho Santa Fe, CA), Dube; Susan E. (Carlsbad, CA), Jochelson; Philip (San Diego, CA), Kavey; Neil B. (Chappaqua, NY)
Assignee: Pernix Sleep, Inc. (Morristown, NJ) ProCom One, Inc. (San Marcos, TX)
Filing Date:Jul 21, 2015
Application Number:14/804,595
Claims:1. A method for treating sleep maintenance insomnia characterized by fragmented sleep during the 8.sup.th 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 is between about 0.5 and about 6 mg and is administered prior to the start of the sleep period.

2. The method of claim 1, wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation.

3. The method of claim 1, wherein the sleep maintenance insomnia is a chronic insomnia.

4. The method of claim 1, wherein the sleep maintenance insomnia is a non-chronic insomnia.

5. The method of claim 1, wherein the sleep maintenance insomnia is a transient insomnia.

6. The method of claim 1, wherein the patient experiences a sleep period that terminates during the final 45 minutes of said period.

7. The method of claim 1, wherein the patient experiences a sleep period that terminates during the final 30 minutes of said period.

8. The method of claim 1, wherein the dosage of doxepin is about 1 mg.

9. The method of claim 1, wherein the dosage of doxepin is about 3 mg.

10. The method of claim 1, wherein the dosage of doxepin is about 6 mg.

11. A method for treating sleep maintenance insomnia characterized by early awakenings during the 8.sup.th 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 is between about 0.5 and about 6 mg and is administered prior to the start of the sleep period.

12. The method of claim 11, wherein the dosage is effective to improve the sleep maintenance insomnia while minimizing next day residual sedation.

13. The method of claim 11, wherein the sleep maintenance insomnia is a chronic insomnia.

14. The method of claim 11, wherein the sleep maintenance insomnia is a non-chronic insomnia.

15. The method of claim 11, wherein the sleep maintenance insomnia is a transient insomnia.

16. The method of claim 11, wherein the dosage of doxepin is about 1 mg.

17. The method of claim 11, wherein the dosage of doxepin is about 3 mg.

18. The method of claim 11, wherein the dosage of doxepin is about 6 mg.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.