Many people take sedatives to help them sleep. The Food and Drug Administration (FDA) is reminding consumers that some drugs to treat insomnia could make them less able the next morning to perform activities for which they must be fully alert, including driving a car.

FDA has informed manufacturers that the recommended dose should be lowered for sleep drugs approved for bedtime use that contain a medicine called zolpidem. FDA is also evaluating the risk of next-morning impairment in other insomnia medications.

People with insomnia have trouble falling or staying asleep. Zolpidem, which belongs to a class of medications called sedative-hypnotics, is a common ingredient in widely prescribed sleep medications. Some sleep drugs contain an extended-release form of zolpidem that stays in the body longer than the regular form.

FDA is particularly concerned about extended-release forms of zolpidem. They are sold as generic drugs and under the brand name Ambien CR. New data show that the morning after use, many people who take products containing extended-release zolpidem have drug levels that are high enough to impair driving and other activities. FDA says that women are especially vulnerable because zolpidem is cleared from the body more slowly in women than in men.

FDA also found that some medicines containing the immediate-release form of zolpidem can impair driving and other activities the next morning. They are marketed as generic drugs and under the following brand names:

  • Ambien (oral tablet)
  • Edluar (tablet placed under the tongue)
  • Zolpimist (oral spray)

FDA has informed the manufacturers of products containing zolpidem that the recommended dose for women for both immediate- and extended-release products should be lowered. FDA is also suggesting a lower dose range for men.

Drowsiness is already listed as a side effect in the drug labels of insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. However, people with high levels of zolpidem in their blood can be impaired even if they feel wide awake. “All insomnia drugs are potent medications, and they must be used carefully,” says Russell Katz, M.D., director of FDA’s Division of Neurology Products.

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Nutrition Facts Labels

May 16, 2013

When you’re walking down the aisles of a supermarket, it’s not unusual to see fellow shoppers reading the information on the back of a food package, box or can.  They might want to know how many calories are in the food, or they might be watching their sodium intake.

They could be trying to limit sugars and eat more dietary fiber. Or they could be parents trying to make the most nutritious choices for their children.

All this information is available thanks to an important addition to food packaging that was introduced to the American public 20 years ago: the Nutrition Facts label. This familiar rectangular box provides, in a standard format, important information about the nutritional content for most packaged foods, including breads, cereals, canned and frozen foods, snacks, desserts and drinks.

“It was revolutionary,” says Jessica Leighton, Ph.D., senior nutrition science and policy advisor in FDA’s Office of Foods and Veterinary Medicine. “For the first time, people had consistent information they need right at the point of purchase for the majority of packaged food products.”

In the years since FDA issued the final rule for this labeling on Jan. 6, 1993, the Nutrition Facts label has influenced many companies to make their foods more healthful. Additionally, notes Claudine Kavanaugh, Ph.D.,M.P.H.,R.D., a scientist at the agency, “FDA was really a trailblazer in nutrition labeling. The Nutrition Facts label has been adapted by countries around the world that have chosen to mandate food.

Label Use Increasing

The Nutrition Facts label was mandated after passage of the Nutrition Labeling and Education Act of 1990. Before it became standard practice, manufacturers provided nutritional information on a voluntary basis that wasn’t consistent from product to product, explains Felicia Billingslea, M.S., director of FDA’s food labeling and standards staff.

“The label is all about the attributes of the food,” says Billingslea. “It’s not to say that this is a good food or a bad food. It provides information that consumers can use and rely upon in developing healthful diets for themselves.”

FDA survey data shows that use of the Nutrition Facts label has been increasing. In comparing the Health and Diet Survey conducted in 2002 with the most recent one conducted in 2008, the percentage of consumers reporting that they often use the label rose from 44 to 54 percent.

This usage has influenced many companies to change their ingredients to make the foods more healthful and thus more appealing to many consumers.

FDA cites as an example the decrease in consumption of trans fat, which has been linked to heart disease, primarily because of a decrease in manufacturers’ use of partially hydrogenated oils. From the late 1990s to 2010, trans fat intake in adults decreased from 4.6 grams to 1.3 grams per day, with most of the reduction occurring after trans fat was added to the food label in 2003.

FDA has oversight of more than 166,000 registered domestic food facilities, including manufacturers, processors, warehouses, storage tanks and grain elevators. Under the new preventive control rules, most human food facilities would be required to have a written plan that

  • evaluates hazards that are reasonably likely to occur in food, such as pathogens (disease-causing organisms) and allergens.
  • specifies the steps that will be put in place to minimize or prevent those hazards.
  • specifies how these controls will be monitored.
  • maintains routine records of the monitoring.
  • specifies what actions will be taken to correct problems that arise.

The plan would specify the steps that will be put in place to minimize or prevent those hazards, and the actions that will be taken when problems arise.

Food facilities “must think up front about what they have to do to keep the food safe,” says Michael Taylor, FDA deputy commissioner for foods.

“While the plan will come from the food companies, the planning and execution are done under the watchful eye of FDA,” notes Donald Kraemer, senior advisor at FDA’s Center for Food Safety and Applied Nutrition. “The agency will evaluate the plans and will continue to inspect the facilities,” he says.

Produce Safety

These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:

  • Irrigation and other agricultural water
  • Farm worker hygiene
  • Manure and other additions to the soil
  • Intrusion of animals in the growing fields.
  • Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.

FDA staff traveled to 13 states and numerous farms to get a first-hand understanding of the diversity of farms and farming practices. “We met with Amish growers in the Ohio valley, organic and sustainable farmers throughout the nation’s heartland, small farmer cooperative members who supply major metropolitan areas, and large commercial growers and shippers,” says Kraemer.

Kraemer explains that there are many variables to consider. With water, for example, the actions farmers would be required to take depend in part on the kind of irrigation system used and whether the water comes in direct contact with the fruit or vegetable. The bottom line, though, would be that “you can’t use water that would cause food to be contaminated,” he says.