The US FDA has approved Sanofi-aventis’ Ambien CR (zolpidem tartrate extended-release tablets) CIV, a new extended-release formulation of the number one prescription sleep aid, for the treatment of insomnia. Ambien CR is non-narcotic and a non-benzodiazepine, formulated to offer a similar safety profile to Ambien with a new indication for sleep maintenance, in addition to sleep induction.
Ambien CR is the first and only extended-release prescription sleep medication to help people with insomnia fall asleep fast and maintain sleep with no significant decrease in next day performance. Ambien CR, a bi-layered tablet, is delivered in two stages. The first layer dissolves quickly to induce sleep. The second layer is released more gradually into the body to help provide more continuous sleep.
"Insomnia is a significant public health problem, affecting millions of Americans. Insomnia impacts daily activities and is associated with increased health care costs," said James K. Walsh, Executive Director and Senior Scientist, Sleep Medicine and Research Centre at St. Luke's Hospital in St. Louis, Missouri.