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Claims for Patent: 8,242,131

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Claims for Patent: 8,242,131

Title:Methods of treating middle-of-the-night insomnia
Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.
Inventor(s): Singh; Nikhilesh (Mill Valley, CA), Pather; Sathasivan Indiran (Greenbrae, CA)
Assignee: Transcept Pharmaceuticals, Inc. (Pt. Richmond, CA)
Application Number:11/439,874
Patent Claims: 1. A method of treating middle-of-the-night insomnia in a non-elderly patient without prophylactically administering zolpidem, comprising: dosing the patient with a pharmaceutical composition comprising about 0.5 to about 4.75 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects.

2. The method of claim 1, wherein the patient resumes sleep within 30 minutes.

3. The method of claim 1, wherein about 50% of the maximum plasma concentration (C.sub.max) of zolpidem is reached in the patient within about 30 minutes or less of dosing.

4. The method of claim 1, Wherein the pharmaceutical composition comprises about 3.0 mg to about 3.75 mg of zolpidem hemitartrate.

5. The method of claim 1, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa.

6. The method of claim 1, wherein the pharmaceutically acceptable form of zolpidem is a salt form of zolpidem.

7. The method of claim 1, wherein the pharmaceutical composition further comprises sodium stearyl fumarate.

8. The method of claim 1, wherein the pharmaceutical composition comprises about 3.5 mg of zolpidem hemitartrate.

9. The method of claim 4, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa.

10. The method of claim 8, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa.

11. The method of claim 1, wherein the pharmaceutical composition is free of other hypnotic agents.

12. A method of treating middle-of-the-night insomnia in an elderly patient without prophylactically administering zolpidem, comprising: dosing the patient with a pharmaceutical composition comprising about 1.5 to about 2.5 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects.

13. The method of claim 12, wherein the patient resumes sleep within 30 minutes.

14. The method of claim 12, wherein about 50% of the maximum plasma concentration (C.sub.max) of zolpidem is reached in the patient within about 30 minutes or less of dosing.

15. The method of claim 12, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa.

16. The method of claim 12, wherein the pharmaceutically acceptable form of zolpidem is a salt form of zolpidem.

17. The method of claim 12, wherein the pharmaceutical composition further comprises sodium stearyl fumarate.

18. The method of claim 12, wherein the pharmaceutical composition comprises about 1.75 mg of zolpidem hemitartrate.

19. The of claim 18, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa.

20. The method of claim 12, wherein the pharmaceutical composition is free of other hypnotic agents.

21. The method of claim 1, wherein the patient has a normal capacity to metabolize zolpidem.

22. The method of claim 1, wherein the pharmaceutical composition comprises about 3.5 mg of zolpidem hemitartrate, wherein the pharmaceutically acceptable form of zolpidem is a salt form of zolpidem, wherein the pharmaceutical composition is free of other hypnotic agents, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa, and wherein the patient resumes sleep within 30 minutes.

23. The method of claim 22, wherein about 50% of the maximum plasma concentration (C.sub.max) of zolpidem is reached in the patient within about 30 minutes or less of dosing.

24. The method of claim 12, wherein the pharmaceutical composition comprises about 1.75 mg of zolpidem hemitartrate, wherein the pharmaceutically acceptable form of zolpidem is a salt form of zolpidem, wherein the pharmaceutical composition is free of other hypnotic agents, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa, and wherein the patient resumes sleep within 30 minutes.

25. The method of claim 24, wherein about 50% of the maximum plasma concentration (C.sub.max) of zolpidem is reached in the patient within about 30 minutes or less of dosing.
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