FDA Requests Label Changes for Sleep Disorder Drugs

The Doctor's Guide reports that 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 like dangerous behaviors, allergic reactions, and even anaphylaxis (a severe, life-threatening allergic reaction).

One potential risk is sleep-driving. Yes, sleep-driving, defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

Drugs affected by the label change include: Ambien, Busitol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and Sonata.

See The Importance of Healthy Sleep for tips on how to sleep well without potentially dangerous drugs.

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