Drugs included in the label warning update are the following 13 products:

• Ambien/Ambien CR (Sanofi Aventis)
• 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)

The FDA recently demanded stricter warnings on the labels of various prescription sleep medications in response to some alarming side-effects. Most notably, some sleeping pill patients have been driving in their sleep; in addition to sleep-driving, those on sleep medications are also completing other “complicated activities” while sleeping, including eating, making phone calls, and having sex.

Over a dozen sleep-driving cases have been reported, according to the FDA, and many more could be going unreported. Rep. Patrick Kennedy is perhaps the best-known example: he crashed his car after taking Ambien and Phenergan (which also acts as a sedative). He had no recollection of the accident.

Another side effect included in the updated warning on drug labels is severe allergic reaction, which can be fatal, and facial swelling. Beyond the updated labeling, doctors will be sent letters detailing the updated warnings and patients will soon be supplied with pamphlets explaining the risks of sleeping pills and steps to take to avoid problems.

If you are currently taking a prescription sleep aid, you should contact your health care provider. The FDA does not recommend discontinuing your medication without first speaking with your doctor.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

• Ambien/Ambien CR (Sanofi Aventis)
• 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)

For more information on the sedative hypnotic products and sleep disorders, visit FDA’s Sedative-Hypnotics Information; also see
FDA information on Sleep Disorders and FDA Insomnia information.