Zolpimist Oral Spray
Generic Name: zolpidem tartrate
Date of Approval: December 19, 2008
Company: NovaDel Pharma Inc.
Treatment for: Insomnia
FDA Approves Zolpimist
The U.S. Food and Drug Administration (FDA) has approved Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien, the world's leading sedative hypnotic for the treatment of insomnia.
NovaDel submitted its Zolpimist application using the FDA's 505(b)(2) process 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 versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between Zolpimist and Ambien. Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
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