First Generics of Ambien Approved

The FDA yesterday announced approval of generic Ambien (zolpidem).

The agency granted approval for 5- and 10-mg formulations of zolpidem to 13 different manufacturers. Zolpidem is approved for the short-term treatment of insomnia.

The generics will carry the same warning that the FDA recently put in place for other sedative-hypnotic drugs regarding severe allergic reactions and complex sleep-related behaviors such as sleep driving.