Buccal, polar and non-polar spray containing zolipidem

Abstract

Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.

1 - 62 . (canceled) 
     
     
         63 . An oral spray composition comprising
 zolpidem tartarate in an amount of about 4-5% by weight of the total composition,   propylene glycol in an amount about 30-40% by weight of the total composition, and   a flavoring agent at in an amount about 0.1-0.3% by weight of the total composition.   
     
     
         64 . The composition of  claim 63 ,
 wherein the Zolpidem tartarate is present in an amount of about 4.66%,   propylene glycol is present in an amount about 35%,   and the flavoring agent is present at about 0.26%.