# FDA News

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  **FOR IMMEDIATE RELEASE**\                      **Media Inquiries:**\
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  March 14, 2007                                  Kimberly Rawlings\
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## FDA Requests Label Change for All Sleep Disorder Drug Products 

> 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.
> These risks include severe allergic reactions and complex
> sleep-related behaviors, which may include sleep-driving. Sleep
> driving is defined as driving while not fully awake after ingestion of
> a sedative-hypnotic product, with no memory of the event.
>
> \"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.

-   Complex sleep-related behaviors which may include sleep-driving,
    making phone calls, and preparing and eating food (while asleep).

> 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.
>
> 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.
>
> 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>;\
> [www.fda.gov/womens/getthefacts/sleep.html](http://www.fda.gov/womens/getthefacts/sleep.html)
> and
> [www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html](http://www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html).
>
> \####