The Dangers Of Sleeping Pills

Sleeping pills promise a restorative night of slumber, but some people who use them experience anything but peaceful rest. They may make phone calls, prepare and eat food, drive and engage in sexual activity, -- all while asleep and with no recollection of their bizarre behaviour.

Reports about these rare but dangerous side effects of sleeping pills have increased in recent years, since more people have begun to use these drugs. Headlines suggesting sleeping pills shouldered some of the blame for politician Patrick Kennedy’s car accident near the Capitol building, and actor Helath Ledger’s drug overdose fueled a flurry of media attention.

Officials at the US Food and Drug Administration also have taken notice. The agency reviewed the postmarketing data about adverse events for the sedative-hypnotics, says a spokesperson at the division of neurology products at the FDA’s Center for Drug Evaluation and Research. Based on that review, the FDA requested that all manufacturers of their drug class include stronger warnings on their product labeling about potential risks, including complex sleep related behaviours and severe allergic reations. Although most specialists consider sleeping pills generally safe, they acknowledge that anyone taking these drugs could experience such side effects. Even those using the drugs properly could have an idiosyndcratic sesponse that causes an adverse event. The likelihood and severity of such an event increases with higher doses and with using central nervous system depressants, such as alcohol, cough medicines, antihistamines and other sleep aids.

Many experts believe the product labeling that warns of these risks may not be effective enough in communicating their scope and gravity.

Approximately 285.000 americans age 12 and older reporten sedative use within the past 30 days, according to the most recent data from the National Survey on Drug Use and Health.

Sales of sleeping pills generate more than $ 4,5 billion a year in the USA. Those figures are expected to grow due to drug manufacturers’ aggressive direct to consumer marketing campaigns.

Most sleeping pills used today are sedative hypnotics and belong to a class of drugs known as nonbenzodiazepines. They affect the same brain receptors as drugs that treat anxiety.

“We are talking about drugs that act on the brain and are changing levels of consciousness. Weird things can happen with these drugs”

Those weird things include the complex sleep related behaviours that sedative-hypnotic product labels now warn against. Message boards across the country chronicle personal accounts of such adverse events.

One user said he was charged with drug abuse with police for going to a sandwich shop at 11.30 pm under the influence of sleeping pills. After he got out of the car, a police officer nearby noticed he was “out of it”. The man has no memory of the night and describes it as a blackout.

“Yes, we certainly do ses those confusional episodes in the clinic. It might be only around 1 percent of patients who experience them, but when they experienced, they are very disturbing and often dangerous”

The FDA determined it was important to alert people about these behaviour, especially sleep driving, because its an activity that might put patients and the community at risk. The warning label changes required drug manufacturers to make more prominent statements about potential side effects related to these drugs. The FDA also requested that manufacturers develop patient medication guides in addition to the strengthened labeling. The guides contain FDA approved information about proper use and emphasize that consumers ahould avoid taking these drugs with alcohol and or other central nervous system depressants. Patients, caregivers and families receive these guides when the medication is dispensed and are advised to read the information before using the product. So far, the agency has received high compliance from drug manufacturers. The majority have incorporated the requested class labeling and have produced medication guides for distribution with their products. Data are not available yet to indicate whether there has been a change in prescribing patterns since the labeling changes took effect.

INCREASED FDA WARNINGS