Treatment of sleep disturbances
The present invention provides a new composition for treating pain-associated sleep disturbances, especially shortened sleep duration, comprising ibuprofen and diphenhydramine. The composition is further prepared as a bilayer tablet or caplet, or alternatively as a soft gelatin capsule composition, to prevent interaction between the active ingredients.
1. A method of treating a patient suffering from a pain-associated sleep disturbance comprising administering a liquid composition formulated inside a soft gelatin capsule to the patient,
wherein the liquid composition consists of:
from about 200 to about 400 mg of ibuprofen;
from about 10 to about 50 mg of diphenhydramine;
polyethylene glycol;
potassium hydroxide; and
water.
2. The method of claim 1 , wherein the sleep disturbance affects sleep duration.
3. The method of claim 1 , wherein the ibuprofen and diphenhydramine are dissolved in the polyethylene glycol, potassium hydroxide and water solution.
4. The method of claim 1 , wherein the diphenhydramine is present as diphenhydramine HCI or diphenyhydramine citrate.
5. The method of claim 4 , wherein the diphenhydramine HCI is present in a range from about 12.5 mg to about 50 mg.
6. The method of claim 5 , wherein the diphenhydramine HCI is present in a range from about 25 mg to about 50 mg.
7. The method of claim 6 , wherein the diphenhydramine HCI is present in an amount of about 25 mg.
8. The method of claim 4 , wherein the diphenhydramine citrate is present in a range from about 19 mg to 38 mg.
9. The method of claim 8 , wherein the diphenhydramine citrate is present in an amount of 38 mg.
10. The method of claim 1 , wherein the ibuprofen is present in a range from about 200 mg to about 300 mg.
11. The method of claim 10 , wherein the ibuprofen is present in an amount about 200 mg.
12. The method of claim 1 , wherein one dose of the composition is administered.
13. The method of claim 1 , wherein two doses of the composition are administered.
14. The method of claim 1 , wherein one dose of the composition is administered and a second dose is optionally administered.
15. A method of treating a patient suffering from a pain-associated sleep disturbance comprising administering a liquid composition formulated inside a soft gelatin capsule to the patient,
wherein the liquid composition consists of:
from about 200 mg to about 400 mg ibuprofen,
from about 12.5 mg to about 50 mg diphenhydramine, polyethylene glycol,
potassium hydroxide, and
water.
16. The method of claim 15 , wherein the diphenhydramine is present as diphenhydramine HCI or diphenyhydramine citrate.
17. The method of claim 16 , wherein the diphenhydramine HCI is present in an amount of about 25 mg.
18. The method of claim 16 , wherein the diphenhydramine citrate is present in an amount of 38 mg.
19. The method of claim 15 , wherein the ibuprofen is present in an amount about 200 mg.
20. The method of claim 15 , wherein the ibuprofen and diphenhydramine are dissolved in the polyethylene glycol,potassium hydroxide and water solution.
21. The method of claim 15 , wherein one dose of the composition is administered.
22. The method of claim 15 , wherein two doses of the composition are administered.
23. The method of claim 15 , wherein one dose of the composition is administered and a second dose is optionally administered.