Zolpidem (AMBIEN) Reinvented As Zolpidem Sublingual (EDLUAR) For Sleep

The Food and Drug Administra­tion (FDA) approved zolpidem sublingual tablets (EDLUAR) in March 2009 for the short-term treat­ment of difficulty falling asleep.

New drugs mean more choices for patients, right? Not this time.

EDLUAR contains the same active ingredient as the popular sleeping pills zolpidem immediate release (AMBIEN) and zolpidem CR (AMBIEN CR; extended release).

EDLUAR has the same physical effect, the same amount of drug that is absorbed into the bloodstream, and the same maximum blood levels in patients as AMBIEN does. This means, by definition, that the two drug forms are bioequivalent.

The only difference between AMBIEN, AMBIEN CR and EDLUAR (besides the name) is the way each is taken.

AMBIEN is a pill that is swallowed and ready for immediate absorption into the blood. AMBIEN CR is also a pill that is swallowed, but it is ab­sorbed by the body slowly over time.

EDLUAR, on the other hand, is placed under the tongue until it dis­solves on its own and should not be swallowed.

Contrary to what EDLUAR’s man­ufacturer MEDA Pharmaceuticals may want you to think, EDLUAR is not really a new drug. EDLUAR works just as well as — but no better than — AMBIEN. But EDLUAR is roughly eight times more expensive than generic AMBIEN (a 30-day sup­ply of generic zolpidem costs $17.99, while a 30-day supply of EDLUAR costs $145.97).

EDLUAR is technically a new drug. However, it is really a reinvented AMBIEN. By developing a new dos­age form, the drug’s manufacturer has protected the market from generic competition because a new drug is patent-protected for up to 20 years.

Zolpidem was first approved in the U.S. in 1992. The drug is character­ized as Limited Use on WorstPills.org because it can be habit-forming. In 2008, more than 28 million prescrip­tions were written for zolpidem in the U.S.

Potential side effects

Dependence
EDLUAR works in a fashion similar to that of the family of drugs known as benzodiazepines, which includes diazepam (VALIUM). Both groups of drugs work through the GABA receptor (gamma amino bu­tyric acid, a natural brain chemical). EDLUAR — as well as AMBIEN and AMBIEN CR — can result in depen­dence and is classified as a controlled substance.

Severe allergic reactions
Some patients have experienced severe allergic reactions when taking EDLUAR. Symptoms include swell­ing of the tongue or throat, trouble breathing, and nausea and vomiting. If patients develop any of the follow­ing symptoms, they should go to the emergency room or get emergency medical help.

Abnormal thinking and behavioral changes
Patients taking EDLUAR alone and at usual doses are at risk of engag­ing in the following activities while sleeping:

• driving a car (sleep-driving)
• preparing and eating food
• talking on the phone
• having sex
• walking

These behaviors may be more likely in patients who take more than the recommended dose. Drinking al­cohol and/or using other central ner­vous system depressants while taking EDLUAR also appear to increase the risk of such behaviors.

Due to the risk to the patient and the community, patients who report sleep-driving should strongly consider discontinuing their use of EDLUAR.

What You Can Do

Read the Medication Guide for EDLUAR, AMBIEN and AMBIEN CR before you take them. You can get these guides from your local pharmacist or on the FDA’s website at: http://www.fda.gov/Drugs/Drug­Safety/ucm085729.htm.

Patients who require short-term treatment for difficulty falling asleep should consider generic AMBIEN instead of EDLUAR.

Do not abruptly stop taking any sleep medications without consulting your physician because of the pos­sibility of withdrawal reactions.

Consumers may report serious adverse events or product qual­ity problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.

Online: https://www.accessdata.fda.gov/scripts/medwatch/med­watch-online.htm
Regular Mail: use postage-paid FDA form 3500 and mail to Med­Watch, 5600 Fishers Lane, Rock­ville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088