Sleeping Aids - FDA Requests Label Change

The use of sedative-hypnotic drug products has increased - due in great part to savvy ad campaigns which make consumers aware of drugs that may benefit or enhance quality of life.

Sedative-hypnotic drugs are used to induce sleep, to help maintain sleep or as a combination of both.

If you are taking any of the following, take note that your prescription label may come with a new label via request of the FDA who is seeking stronger language regarding potential health risks:

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)

Health Risks Associated With Sedative-Hypnotic Drugs

The FDA cites the following health risks associated with the use of sedative-hypnotic drugs:

- Anaphylaxis (severe allergic reaction);

- Angioedema (severe facial swelling);

- Complex sleep-related behaviors. This may include performing normal daily activities, then having no recollection of doing such. The FDA cited the following sleep-related behaviors: sleep-driving, making phone calls, and preparing and eating food while asleep.

The FDA has also issued a request to sedative-hypnotic manufacturers to develop a medication guide for patients which advises them of risks and precautions which can be taken while using sedative-hypnotic products.

If you are currently taking a sedative-hypnotic product, please note the following precautions:

- Do not combine sedative-hypnotic products with alcohol.
- Do not combine sedative-hypnotic products with central nervous system depressants.
- Do not discontinue use of sedative-hypnotic products without first consulting with your family doctor.

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