The F.D.A. ordered the makers of Ambien, Lunesta and 11 other commonly used sleep medications to issue strong new label warnings about those risks, and to produce brochures about safe use of the drugs. Pharmacies would give the brochures to patients when prescriptions are dispensed.
The agency will also require label warnings to note the possibility of severe allergic reactions and facial swelling associated with the use of such sleep medications.
The agency had been reviewing the side effects of sleeping pills since last year, after some users of the widely prescribed drug Ambien complained that they sleepwalked and gorged themselves on food or were arrested while driving in their sleep.
In each case the consumers had no recollection of the events, which occurred after they took Ambien and headed for bed.
The agency said that it had reviewed its database of reports of problems with the 13 commonly used sleep medications and concluded that labeling changes were needed. In a news release today, the F.D.A. warned patients of the potential for “complex sleep-related behaviors” which may include “sleep-driving, making phone calls and preparing and eating food (while asleep).”
The release defined “sleep driving” as “driving while not fully awake after ingestion of a sedative hypnotic, with no memory of the event.”
The F.D.A. also said it was taking the added step of asking manufacturers to conduct additional clinical studies involving sleep driving and other complex behaviors associated with taking the medications.
Besides Ambien and Lunesta, the drugs include Sonata and Rozerem, and a number of older medications.
The F.D.A.’s move follows a warning last month by authorities in Australia, where Ambien is marketed as Stilnox. The Australian drug agency said it had uncovered a variety of unusual activities by consumers using the product, including sleep-driving, sleep-eating, and, in one case, a woman who painted the front door of her home while asleep.
Here are the 13 sleep drugs, and their makers, as listed by the F.D.A.:
•
Ambien/AmbienCR (Sanofi-Aventis)
Butisol Sodium (MedPointe Pharmaceuticals)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharmaceuticals)
Doral (Questcor Pharmaceuticals)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
ProSom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Eli Lilly)
Sonata (King Pharmaceuticals
Source: Newyorktimes
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