Zolpimist (zolpidem tartrate, from NovaDel Pharma) Oral Spray has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist uses NovaDel’s proprietary NovaMist oral spray technology, providing rapid drug absorption from the oral mucosa.
This approval was based on results from two randomized, open-label, dose-ranging clinical trials comparing Zolpimist with Ambien (zolpidem tartrate, from sanofi-aventis) that demonstrated bioequivalence between Zolpimist and Ambien.
Zolpimist will be available in 5mg and 10mg dosage strengths.
For more information call (908) 782-3431 or visit www.novadel.com.