FDA Requests Label Change for All Sleep Disorder Drug Products

Florence Cardinal Health Guide
  • For those of us who have been diagnosed with sleep disorders, medications often become a part of our daily lives.  Still, many people aren't aware of the possible side effects of the sleep medication they take. 


    If you’re one of the many of us who take medications to help us sleep, you should be aware that the U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.


    Sedative hypnotics (aka sleeping pills) have many possible side effects and drug interactions, and patients using these medications noted strange behavior in addition to the side effects listed on the initial FDA label. Although all of these sleep aids can cause these problems, one medication, Ambien (zolpidem) has been prominently featured in the news as a cause of these problems, as it has the majority of market share for sleeping pills.  

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    People who are prone to sleepwalking found an increase in this disorder with Ambien use. Another problem occurring with Ambien use was night bingeing and excessive weight gain. Others exhibited other bizarre and dangerous behavior, including driving and making phone calls.


    In addition to the sleepwalking and other strange behavior, severe allergic reactions have been noted in some patients. In addition to the changes in labeling, the FDA recommends that product manufacturers send letters to health care providers informing them of the new warnings. They also recommend that drug manufacturers develop Patient Medication Guides for the products that include proper use and potential risks and precautions. These would be given to patients when the drug is prescribed.


    Patients taking Ambien or another sedative hypnotic should avoid alcohol and other central nervous depressants including valium, librium and similar drugs. Patients should be encouraged to read the handouts and talk to their doctor about any questions and concerns before taking the drugs.


    If you take medications to treat sleeping problems, one of the best things you can do for your health is to let family members and friends know of the side effects of your meds so they can help monitor your behavior.




    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 http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;



Published On: April 23, 2007