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Senior Citizen Alerts
Senior Citizens' Memory Problems May Be Due to Their
Sleeping Pills
FDA wants stronger warnings on drugs for
sleep disorders
 March 16, 2007 – Senior citizens with memory
problems may find it is not dementia, but the medicine they are taking
for a sleep disorder that is causing them to forget. "Sleep-driving" -
driving not fully awake after taking a sedative-hypnotic drug and then
having no memory of the trip – is one of problems highlighted by the
U.S. Food and Drug Administration in requesting manufacturers of these
drugs add new warnings to their labels.
Sleep driving is just one of the "complex
sleep-related" behaviors related to memory loss that has been reported
by people taking these sedative-hypnotic drug products, a class of drugs
used to induce or maintain sleep.
Thirteen medications were told to strengthen their
product labeling to include stronger language concerning potential
risks, which also include severe allergic reactions.
"There are a number of prescription sleep aids
available that are well-tolerated and effective for many people," said
Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation
and Research.
"However, after reviewing the available
post-marketing adverse event information for these products, FDA
concluded that labeling changes are necessary to inform health care
providers and consumers about risks."
In December 2006, FDA sent letters to manufacturers
of products approved for the treatment of sleep disorders requesting
that the whole class of drugs revise product labeling to include
warnings about the following potential adverse events:
● Anaphylaxis (severe allergic reaction) and
angioedema (severe facial swelling), which can occur as early as the
first time the product is taken.
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The medications that are the focus of the revised
labeling include the following 13 products: |
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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)
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● Complex sleep-related behaviors which may
include sleep-driving, making phone calls, and preparing and eating food
(while asleep).
The FDA has been working with the product
manufacturers over the past three months to update labeling, notify
health care providers and inform consumers of these risks.
Along with the labeling revisions, FDA has
requested that each product manufacturer send letters to health care
providers to notify them about the new warnings. Manufacturers will
begin sending these letters to providers starting this week.
In addition, FDA has requested that manufacturers
of sedative-hypnotic products develop Patient Medication Guides for the
products to inform consumers about risks and advise them of potential
precautions that can be taken.
Patient Medication Guides are handouts given to
patients, families and caregivers when a medicine is dispensed. The
guides will contain FDA-approved information such as proper use and the
recommendation to avoid ingesting alcohol and/or other central nervous
system depressants. When these Medication Guides are available, patients
being treated with sleep medications should read the information before
taking the product and talk to their doctors if they have questions or
concerns.
Patients should not discontinue the use of these
medications without first consulting their health care provider, the FDA
warns.
Although all sedative-hypnotic products have these
risks, there may be differences among products in how often they occur.
For this reason, FDA has recommended that the drug manufacturers conduct
clinical studies to investigate the frequency with which sleep-driving
and other complex behaviors occur in association with individual drug
products.
For more information on the sedative hypnotic
products and sleep disorders:
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http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
>>
www.fda.gov/womens/getthefacts/sleep.html and
>>
www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.
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