Drugs
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Sleep Disorder (Sedative-Hypnotic) Drug Information
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.
Drugs
- Ambien, Ambien CR (zolpidem tartrate)
- Butisol sodium
- Carbrital (pentobarbital and carbromal)
- Dalmane (flurazepam hydrochloride)
- Doral (quazepam)
- Edluar
- Halcion (triazolam)
- Intermezzo (zolpidem)
- Lunesta (eszopiclone)
- Placidyl (ethchlorvynol)
- Prosom (estazolam)
- Restoril (temazepam)
- Rozerem (ramelteon)
- Seconal (secobarbital sodium)
- Sonata (zaleplon)
- Zolpimist
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Related Information
FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
5/14/2013FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
1/10/2013FDA Requests Label Change for All Sleep Disorder Drug Products [ARCHIVED]
(3/14/2007)
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