On March 14, 2007, the U.S. Food and Drug Administration (FDA) demanded that Sanofi Aventis, the manufacturer of Ambien, a sedative-hypnotic drug toughen its product labeling to include harder language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
Along with the labeling revisions, the FDA requested that Sanofi Aventis send letters to health care providers to notify them about the new warnings. Other sedative-hypnotic medications that are the focus of the revised labeling include:
- Butisol Sodium (Medpointe Pharm HLC)
- Carbrital (Parke-Davis)
- Dalmane (Valeant Pharm)
- Doral (Questcor Pharms)
- Halcion (Pharmacia & Upjohn)
- Lunesta (Sepracor)
- Placidyl (Abbott)
- Prosom (Abbott)
- Restoril (Tyco Healthcare)
- Rozerem (Takeda)
- Seconal (Lilly)
- Sonata (King Pharmaceuticals)
Concerns have been raised about the safety of Ambien (zolpidem tartrate), the anti-insomnia drug manufactured by Sanofi-Aventis. Reports are surfacing people taking Ambien are experiencing sleepwalking, memory loss / amnesia, binge eating while sleeping, having sex while sleeping, and other disturbing side effects. Some of the most serious side effects involve Ambien users having auto accidents the day after taking Ambien due to daytime sleepiness and the lingering feeling of being drugged. One disturbing report concerned a physician at Massachusetts General Hospital in Boston who could not recall advising residents on rounds the morning after taking Ambien.
Ambien Studies Researchers in Minnesota are looking at instances where people taking Ambien for insomnia got up in the middle of the night and engaged in such behaviors as binge eating. The patients reportedly remembered nothing of the experience upon awakening. Dr. Michael Cramer Vornemann, a researcher at the University of Minnesota Medical School and the Hennepin County Medical Center in Minneapolis, said it appears that those with a prior history of sleep walking and also women may be at higher risk for experiencing these side effects. The researchers believe that thousands of people taking Ambien experience sleep related eating disorders. The researchers looked at older sleep aids and found that these side effects are unique to Ambien, and possibly other newer medications such as Lunesta and Sonata. Mayo Clinic research conducted earlier on Ambien had similar findings. Consumer group Public Citizen has called for very limited use of Ambien because it causes temporary amnesia.
Sleep Medication Usage According to the American Academy of Sleep Medicine, an estimated 30 million people in the U.S. take sleep medications, which represents a huge increase in recent years. The increase is partly due to manufacturers of anti-insomnia drugs investing heavily in consumer advertising. Sleep-induced side effects may be rising because of the increasing use of Ambien and other anti-insomnia medications.
Legal Help for Ambien Side Effects Victims
If you or a loved one took Ambien and suffered memory loss, sleep walking, or other harmful side effects, contact us for a free case evaluation about your case today. Please fill out the short form at the right, or call our lawyers at 1-800-YOURLAWYER (1-800-968-7529).