In 2005, 6,000 emergency-room cases nationwide involved Ambien and other medications containing the hypnotic drug zolpidem--such as Ambien CR
, Edluar and Zolpimist.
A Zolpidem (generic), sold also under brand names Ambien, Ambien CR
(extended release), Edluar (sublingual, which means under the tongue), and Zolpimist (oral spray), has been found to cause next-morning impairment for activities that require patients to be alert, including driving.
Food and Drug Administration has announced new, lower dosing requirements for certain sleep drugs that contain zolpidem, including Ambien, Ambien CR
, Edluar, and ZolpiMist.
was taken as a temporary treatment for his insomnia.
As the first company to file an ANDA that contained a paragraph IV certification for Ambien CR
Sanofi-Aventis's dominance in the insomnia market is under threat due to patent challenges to Ambien CR
and Datamonitor expects generic versions of this market leading brand to enter the US over the forecast period.
from Tecumseh, Michigan: Studies of Ambien (zolpidem tartrate) and Ambien CR
(controlled-release) suggest no long-term effect on memory or brain performance in people taking the prescription sleep aid.
Sanofi spokeswoman Emmy Tsui said in an e-mailed statement that "versions of Ambien CR
that infringe Sanofi-Aventis' intellectual property rights cannot be marketed lawfully.
We see revenues for both companies increasing dramatically over the next few years, even though indiplon will most likely be the fourth new entrant into the insomnia space after the launches of Sepracor's Lunesta, Takeda Pharmaceutical's Rozerem, and Sanofi-Aventis Group's Ambien CR
In addition to the novel drug Rozerem (ramelteon), the Food and Drug Administration approved the hypnotic drugs Lunesta (eszopiclone) and a new, slow-release formulation of zolpidem called Ambien CR
Evidence of this association was so compelling, the Food and Drug Administration recently announced that it is requiring manufacturers of Ambien, Ambien CR
, Zolpimist, and Edluar, sleep aids that contain zolpidem, to lower recommended doses.
The company also markets the controlled-release formulation, as Ambien CR
, which was approved in 2005.