COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
The present invention provides compositions having a therapeutically effective amount of zolpidem, carbonate buffer, bicarbonate buffer, and a mixture comprising large and fine particles of silicon dioxide. Compositions having a therapeutically effective amount of zolpidem, carbonate buffer, bicarbonate buffer, and sodium stearyl fumarate are also described.
1 . A pharmaceutical composition comprising:
about 0.5 mg to about 4.75 mg of zolpidem;
a carbonate buffer;
a bicarbonate buffer; and
sodium stearyl fumarate.
2 . The composition of claim 1 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:10.
3 . The pharmaceutical composition of claim 1 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:5.
4 . The pharmaceutical composition of claim 1 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:2.
5 . The pharmaceutical composition of claim 1 , further comprising a binder and a disintegrating agent.
6 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a lozenge.
7 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a tablet.
8 . The pharmaceutical composition of claim 1 , wherein the carbonate buffer is selected from the group consisting of sodium carbonate, potassium carbonate, calcium carbonate, ammonium carbonate, and magnesium carbonate.
9 . The pharmaceutical composition of claim 1 , wherein the bicarbonate buffer is selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, ammonium bicarbonate, and magnesium bicarbonate.
10 . A solid pharmaceutical composition comprising:
about 0.5 mg to about 4.75 mg of zolpidem;
a carbonate buffer;
a bicarbonate buffer; and
a mixture comprising large and fine particles of silicon dioxide.
11 . The composition of claim 10 , wherein the mixture comprises a 4:1 ratio of large particles to fine particles.
12 . The composition of claim 10 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:10
13 . The pharmaceutical composition of claim 10 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:5.
14 . The pharmaceutical composition of claim 10 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:2.
15 . The pharmaceutical composition of claim 10 , further comprising a binder and a disintegrating agent.
16 . The pharmaceutical composition of claim 10 , wherein the pharmaceutical composition is a lozenge.
17 . The pharmaceutical composition of claim 10 , wherein the pharmaceutical composition is a tablet.
18 . The pharmaceutical composition of claim 10 , wherein the carbonate buffer is selected from the group consisting of sodium carbonate, potassium carbonate, calcium carbonate, ammonium carbonate, and magnesium carbonate.
19 . The pharmaceutical composition of claim 10 , wherein the bicarbonate buffer is selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, ammonium bicarbonate, and magnesium bicarbonate.
20 . A solid pharmaceutical composition comprising:
a therapeutically effective amount of zolpidem;
a carbonate buffer;
a bicarbonate buffer;
a mixture comprising large and fine particles of silicon dioxide; and
sodium stearyl fumarate.