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Claims for Patent: 8,252,809

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Claims for Patent: 8,252,809

Title:Compositions for treating insomnia
Abstract: The present invention provides compositions 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 N. (Mill Valley, CA)
Assignee: Transcept Pharmaceuticals, Inc. (Pt. Richmond, CA)
Application Number:12/795,934
Patent Claims: 1. A solid unit dosage composition for the treatment of MOTN insomnia, said composition comprising an effective amount of zolpidem or a salt thereof, formulated for delivery of zolpidem across a subject's oral mucosa, wherein said effective amount is an amount of less than 1.30.times.10.sup.-5 moles of zolpidem, and is an amount sufficient to produce a plasma concentration between about 25 ng/ml and about 50 ng/ml within 20 minutes of administration, when evaluated in an appropriate patient population.

2. The solid unit dosage composition of claim 1, which further provides 50% of the maximum plasma concentration (Cmax) of zolpidem in 10 minutes or less.

3. The solid unit dosage composition of claim 2, which further provides blood levels of zolpidem that are less than 20 ng/ml at a time 4 hours after dosing.

4. The solid unit dosage composition of claim 1, further comprising at least one pH-adjusting agent selected from the group consisting of a carbonate salt and a bicarbonate salt.

5. The solid unit dosage composition of claim 1, further comprising a binary buffer system that raises the pH of said subject's saliva to a pH greater than about 8.5, irrespective of the starting pH of saliva.

6. The solid unit dosage composition of claim 5, wherein the binary buffer system consists of sodium carbonate and sodium bicarbonate.

7. The solid unit dosage composition of claim 6, in the form of a quick-dissolving tablet or lozenge.

8. The solid unit dosage composition of claim 5, containing from 0.5 to 4.75 mg of zolpidem hemitartrate.

9. The solid unit dosage composition of claim 5, containing from 1.5 to 2.5 mg of zolpidem hemitartrate.

10. The solid unit dosage composition of claim 5, containing from 3.0 to 3.75 mg of zolpidem hemitartrate.

11. The solid unit dosage composition of claim 1, wherein the zolpidem is delivered across at least one of the sublingual or buccal mucosa.

12. A solid unit dosage composition for the treatment of MOTN insomnia, said composition comprising an effective amount of zolpidem or a salt thereof and at least one buffering agent, formulated for delivery of zolpidem across a subject's oral mucosa, wherein said effective amount is 0.5 to 4.75 mg of zolpidem hemitartrate, and is an amount sufficient to produce a plasma concentration between about 25 ng/ml and about 50 ng/ml within 20 minutes of administration, when evaluated in an appropriate patient population.

13. The solid unit dosage composition of claim 12, wherein the solid unit dosage form dissolves in about 2 minutes or less in the subject's mouth.

14. The solid unit dosage composition of claim 12, wherein at least about 25% by weight of the solid unit dosage form dissolves within about 5 minutes.

15. The solid unit dosage composition of claim 1, wherein the solid unit dosage form dissolves in about 2 minutes or less in the subject's mouth.

16. The solid unit dosage composition of claim 1, wherein at least about 25% by weight of the solid nit dosage form dissolves within about 5 minutes.

17. The solid unit dosage composition as in any of claims 1-6, 15, or 16, containing about 1.75 mg of zolpidem hemitartrate.

18. The solid unit dosage composition as in any of claims 1-6, 15, or 16, containing about 3.5 mg of zolpidem hemitartrate.

19. The solid unit dosage composition of claim 12, which thither provides 50% of the maximum plasma concentration (Cmax) of zolpidem in 10 minutes or less.

20. The solid unit dosage composition of claim 19, which further provides blood levels of zolpidem that are less than 20 ng/ml at a time 4 hours after dosing.

21. The solid unit dosage composition of claim 12, further comprising at least one pH-adjusting agent selected from the group consisting of a carbonate salt and a bicarbonate salt.

22. The solid unit dosage composition of claim 12, further comprising a binary buffer system that raises the pH of said subject's saliva to a pH greater than about 8.5, irrespective of the starting pH of saliva.

23. The solid unit dosage composition of claim 22, wherein the binary buffer system consists of sodium carbonate and sodium bicarbonate.

24. The solid unit dosage composition of claim 23 in the form of a quick-dissolving tablet or lozenge.

25. The solid unit dosage composition as in any of claims 12, 13, 14, 19, 20, 21, 22, 23, or 24, containing about 1.75 mg of zolpidem hemitartrate.

26. The solid unit dosage composition as in any of claim 12, 13, 14, 19, 20, 21, 22, 23, or 24, containing about 3.5 mg of zolpidem hemitartrate.
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