Compositions for treating insomnia
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.
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 1.30×10 −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.