Therapeutic compositions for intranasal administration of zolpidem

摘要

The invention provides sprayable aqueous compositions containing zolpidem or single stereoisomer, mixtures of stereoisomers, pharmaceutically acceptable salts or prodrugs thereof, a solubilizing agent, a water soluble polymer with bioadhesive property. When administered intranasally using a spray device, zolpidem is rapidly absorbed with prolonged intranasal residence time and improved bioavailability. The compositions can be applied for the treatment of insomnia-related disorders such as difficulties with sleep initiation or middle of the night awakenings.

主权项

1. A pharmaceutical composition, comprising:
(i) a compound having Formula I:  or single stereoisomer, mixtures of stereoisomers, pharmaceutically acceptable salts or prodrugs thereof; (ii) HP-β-cyclodextrin; and (iii) at least one aqueous vehicle polymer capable of changing in a nasal fluid a rheological behavior in relation to pH change, in relation to temperature change, or in the presence of ions.