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.
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;
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