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)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital sodium)
• Sonata (zaleplon)