Controlled Release Compositions Containing Zolpidem

A pharmaceutical controlled-release dosage form adapted to release zolpidem or a salt thereof over a predetermined time period, according to a monophasic in vitro profile of dissolution when measured in a type II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M hydrochloric acid buffer at 37° C., wherein less than 40% of the total amount of zolpidem is released between 1 to 30 minutes and the time for release of 90% of the total amount of zolpidem is between 75 to 120 minutes.

A pharmaceutical controlled-release dosage form adapted to release zolpidem or a salt thereof over a predetermined time period, according to a biphasic in vitro profile of dissolution when measured in a type II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M hydrochloric acid buffer at 37° C., wherein 40% or less of the total amount of zolpidem is released between 1 to 30 minutes as an immediate release phase and the time for release of 90% of the total amount of zolpidem is between 75 to 120 minutes as a prolonged release phase.

A pharmaceutical controlled-release monolithic polymeric matrix dosage form comprising zolpidem or a salt thereof along with at least one release rate controlling polymer and at least one pharmaceutical acceptable excipient, adapted to release zolpidem or a salt thereof over a predetermined time period, according to an in vitro profile of dissolution when measured in a type II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M hydrochloric acid buffer at 37° C., wherein 40 to 70% of the total amount of zolpidem is released within 30 minutes and the time for release of 90% of the total amount of zolpidem is between 2 and 6 hours.