FDA Approves Generic Ambien for Treatment of Insomnia

The original, short-acting form of Ambien (zolpidem tartrate), a medication designed for the short-term treatment of insomnia, will now be available in generic form.

Ambien rapidly became a popular sleep medication in the 90s as it is chemically different from conventional hypnotics and benzodiazepines, and therefore is less likely to cause problems with addiction.

While the generic form of Ambien is already available in the U.K, the U.S. Food and Drug Administration (FDA) announced today that approval for the production of zolpidem has been granted to 13 drug manufacturers.

Much to the delight of patients who pay out-of-pocket for expensive sleep medication, the patent for Ambien expired on April 21, 2007, following a 6-month patent extension.

Manufactured by sanofi-aventis Group, which includes U.S. subsidiary Aventis Pharmacuticals, Inc., Ambien was ranked the 13th most popular brand name drug in terms of sales.

However, prescriptions for newer sleep medications, such as Lunesta and Rozerem, with purportedly less side effects or tolerance issues, are on the rise.

The company's own Ambien CR, an extended-release formula, may also be preferred to the original formula for some patients.

Yet, due to the expense and newness of these medications often these sleep medications are not covered by insurance or involve higher co-pays.

This FDA approval for zolpidem will offer U.S. citizens another pharmaceutical option and conceivably the uninsured may pay less than $5 for a month's supply of the drug. That is if zolpidem is added to the list of subsidized generics offered by some pharmacies.

Sleep Aid Dangers

Ambien, along with other sleep medications, have been under fire in the press and by consumer groups for various potential but serious side effects.

In March 2007, the FDA requested new labeling for sedative-hypnotic drug products, including the newer Lunesta, designed to induce sleep. Zolpidem is required to provide this label, also, including the following cautions:

--Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur following a single dose.

--Complex sleep-related behaviors such as sleep-driving, making phone calls, and preparing and/or eating food while sleeping. (Patients have no memory of these behaviors.)

Patients, family members and caregivers are also to receive Patient Medication Guides, or handouts, when such a sleep medication is dispensed. These guides contain FDA-approved information about proper use, avoidance of alcohol and other precautions.

Ambien CR, the long-acting form of zolpidem, is not due for patent expiration until 2019.

Source: FDA
(http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html)
(http://www.fda.gov/bbs/topics/NEWS/2007/NEW01616.html)