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

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 short-term 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.