The FDA approved Zolpimist (zolpidem tartrate) oral spray for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate is the same active ingredient as Ambien. Both 5 mg and 10 mg sprays were approved.
Zolpimist's application was based on data from two randomized, open-label, dose-ranging studies comparing Zolpimist with Ambien tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray vs. tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration and total exposure to drug. The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between Zolpimist and Ambien.
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