FDA Requests New Safety Warnings for AMBIEN (Zolpidem), Other Sleeping Pills

At 2:45 a.m. on May 4, 2006, Rep. Patrick Kennedy (D-R.I.) swerved and crashed into a barricade outside the Capitol building in Washington, D.C.

The next day, Kennedy issued a written statement claiming that he was disoriented after taking the prescribed amount of sleep aid zolpidem (AMBIEN) and an anti-nausea drug, and did not remember the incident. 

In another sleeping pill-related incident, Australian authorities reported in 2001 that a patient gained almost 51 pounds during seven months while taking zolpidem, and no one understood why.

The mystery was solved when she was discovered one night eating in front of a refrigerator, while she was sleeping.

These stories are just some of the incidents publicizing the link between the sleep medication zolpidem and dangerous driving incidents or eating binges.  

According to the February 2007 Australian Adverse Drug Reactions Bulletin, 16 reports of sleep walking (which describes inappropriate or strange automatic behavior while asleep, including binge eating and house painting) had been recorded in patients using zolpidem during the first year the drug was on the market.

In March of this year – almost a year after Rep. Kennedy’s incident – zolpidem again received a great deal of media attention when the Food and Drug Administration (FDA) asked manufacturers of sleeping pills (those used to induce and/or maintain sleep) to include stronger language concerning potential risks of sleep walking and serious allergic reactions in their product labeling. The sleeping pills affected by the FDA’s announcement are listed in the table that accompanies this article.

Patients taking sleep medications could be at risk of severe allergic reactions and complex sleep-related behaviors, which may include sleep driving – driving while not fully awake after ingestion of a sleeping pill, with no memory of the event, according to the FDA. There is also a risk of dependence in patients who use zolpidem.

According to Public Citizen, zolpidem is no more effective than other sleeping pills, but a 30-day supply costs substantially more than a generic alternative which works just as well. We list zolpidem as a “Limited Use” drug because of this exorbitant and unnecessary extra cost.

FDA concerned about side effects
The FDA made its recommendations after reviewing the available post-marketing information about side effects for these products.

The agency wants manufacturers to issue the new warnings because it is concerned about the potential for people taking sleeping pills to engage in dangerous activities while asleep.

It is important to realize that the FDA does not have the authority to mandate drug companies to add safety warnings. Instead, because Congress has not given the agency such authority, the FDA asks begs companies to make changes and then often engages in dangerously prolonged negotiations until a warning is agreed upon. This happened with VIOXX and many other drugs, and now with these warnings on sleeping pills.

The FDA also wants the professional product labels of the listed sleeping pills to warn users of anaphylaxis, a severe type of life-threatening allergic reaction, and angioedema, severe facial swelling that can occur even the first time a sleeping pill is taken. Angioedema can be life-threatening if the throat is affected to the point that breathing becomes difficult. (If either of these conditions develops, emergency help should be summoned immediately or the person with the condition should be transported to an emergency room as soon as possible).  

Unique benefit of sleeping pills is questionable
The effectiveness of sleeping pills is marginal, decreasing the time it takes to fall and stay asleep by mere minutes.

In addition to potentially causing dependence, sleeping pills can also cause daytime sedation, confusion, memory loss, increased risk of auto accidents, poor coordination (which can result in falls and hip fractures), impaired learning ability, slurred speech, and even death.

There are non-pharmacological alternatives to sleeping pills, such as behavioral therapy, that are very effective. Behavioral therapy has been shown in clinical studies to be superior to sleeping pills for managing both short- and long-term insomnia in adults. This research and other alternative remedies for insomnia are discussed on Worstpills.org and in Worst Pills, Best Pills (see January 2007 Worst Pills, Best Pills News).  

Some drugs, which are listed on our Web site and in our book, can also cause insomnia, but sleeping pills may not be the cure. Instead, patients may need to change their dosage or find an alternative drug in consultation with a doctor.  

What You Can Do
If you are experiencing insomnia and have tried other non-pharmacologic means to improve your sleep, ask your physician about a referral to a cognitive behavioral therapy program.

DO NOT suddenly stop taking sleeping pills without consulting your physician because of the possibility of withdrawal reactions.