Sleep Aids: FDA Warnings

Risks Associated with Taking Prescription Insomnia Drugs

The sleep aids widely known as sedatives and hypnotics include popular insomnia medications like Ambien, Lunesta and Rozerem. Despite their popularity, and hence widespread familiarity, these remain highly potent and occasionally dangerous drugs. In recent years as use has increased, the FDA has asked the various pharmaceutical manufacturers to make additions to their warning labels. These requests for more sweeping warnings are intended to increase physician and patient awareness of some risky, but rare, side effects.

Dangerous Side Effects

FDA Logo.The dangerous side effects that the FDA has asked be made more public among drug makers of sleep aids and sleep disorder drugs include:

  • Allergic reactions, including facial swelling and anaphylaxis
  • Sleep behaviors without memory, including sleep walking and sleep driving
  • Next day impairment

In March 2007 the U.S. Food and Drug Administration issued a press release* asking for the cooperation of all pharmaceutical manufacturers whose products include sleep disorder drugs and prescription sleep aids. The list of affected drugs includes brand names like Ambien, Lunesta, Sonata, Rozerem, and Restoril, to name a few.

What raised the FDA’s concerns?

These potent sleep aids are used by millions of Americans and for th eost part have mild side effects. But over the course of time and as more people have begun to use them the results show a few disturbing side effects, particularly the allergic reactions and sleep driving, that had previously gone relatively unpublicized. These are side effects that could be life-threatening or, in the case of sleep driving, endanger the lives of the patient and others.

Know the Risks

Taking prescription sedative-hypnotics is only recommended under the close supervision of your physician. He or she should discuss all the risks and possible side effects and advise you on dosage instructions. When you fill your prescription a pharmacist should also provide you with a patient guidelines sheet or brochure, per the FDA’s request, that offers you a detailed description of the sleep aid you’re taking, dosage instructions, drug interactions, and comprehensive list of side effects and risks, including these newest alerts. For more information on warnings and detailed sleep aid information, visit the FDA website.

FDA press release

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