COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA
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.
1 - 185 . (canceled)
186 . 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.
187 . The composition of claim 186 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:10.
188 . The pharmaceutical composition of claim 186 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:5.
189 . The pharmaceutical composition of claim 186 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:2.
190 . The pharmaceutical composition of claim 186 , further comprising a binder and a disintegrating agent.
191 . The pharmaceutical composition of claim 186 , wherein the pharmaceutical composition is a lozenge.
192 . The pharmaceutical composition of claim 186 , wherein the pharmaceutical composition is a tablet.
193 . The pharmaceutical composition of claim 186 , wherein the carbonate buffer is selected from the group consisting of sodium carbonate, potassium carbonate, calcium carbonate, ammonium carbonate, and magnesium carbonate.
194 . The pharmaceutical composition of claim 186 , wherein the bicarbonate buffer is selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, ammonium bicarbonate, and magnesium bicarbonate.
195 . 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.
196 . The composition of claim 195 , wherein the mixture comprises a 4:1 ratio of large particles to fine particles.
197 . The composition of claim 195 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:10
198 . The pharmaceutical composition of claim 195 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:5.
199 . The pharmaceutical composition of claim 195 , wherein the carbonate buffer and bicarbonate buffer are present in a carbonate:bicarbonate weight ratio of about 1:1 to about 1:2.
200 . The pharmaceutical composition of claim 195 , further comprising a binder and a disintegrating agent.
201 . The pharmaceutical composition of claim 195 , wherein the pharmaceutical composition is a lozenge.
202 . The pharmaceutical composition of claim 195 , wherein the pharmaceutical composition is a tablet.
203 . The pharmaceutical composition of claim 195 , wherein the carbonate buffer is selected from the group consisting of sodium carbonate, potassium carbonate, calcium carbonate, ammonium carbonate, and magnesium carbonate.
204 . The pharmaceutical composition of claim 195 , wherein the bicarbonate buffer is selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, ammonium bicarbonate, and magnesium bicarbonate.
205 . The pharmaceutical composition of claim 195 , wherein the pharmaceutical composition is formulated to dissolve within 8 minutes following administration.