ZolpiMistTM: A new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US

Abstract

ZolpiMist™ is an oral spray formulation of the hypnotic compound zolpidem that was approved by the US Food and Drug Administration in 2008 with an indication for the shortterm treatment of insomnia characterized by difficulty with sleep initiation. It was developed by NovaDel Pharma, Inc. using their patented NovaMist™ spray technology. The recommended doses are 10 mg for adults and 5 mg for elderly and debilitated patients to be taken once daily immediately before bedtime. Each metered spray contains 5 mg of zolpidem. ZolpiMist was approved through the 505(b)(2) pathway, which allowed reference to pre-existing efficacy and safety data for the equivalent doses of zolpidem immediate-release tablets. Bioequivalence and pharmacokinetic characteristics were demonstrated in clinical studies with healthy adult and elderly subjects. ZolpiMist is being investigated for the possible indication of use during middle-of-the-night awakenings when the patient has at least 4 hours available to remain in bed. © 2010 Neubauer.