FLEMINGTON, N.J. The Food and Drug Administration has approved a drug by NovaDel Pharma for the short-term treatment of insomnia characterized by difficulties with sleep initiation, NovaDel announced Monday.
NovaDel said that Zolpimist (zolpidem tartrate) is its second product approved by the FDA that uses its proprietary NovaMist spray technology. The active ingredient in Zolpimist is the same as the one in Sanofi-Aventis’ Ambien.
“We believe that the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” NovaDel board chairman and interim CEO Steven Ratoff said.
Ambien had worldwide sales of $559.3 million for first six months of 2008, according to Sanofi-Aventis financial data.