SOMERSET, N.J., Sept. 8 /PRNewswire/ -- Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. EDLUAR is the first available under-the-tongue formulation of zolpidem tartrate, which is the most prescribed treatment for insomnia. Zolpidem tartrate is also the active ingredient in Ambien(R) oral tablets.
"Insomnia is a serious and common medical problem that affects tens of millions of Americans," said Sharon S. Clarke, president and general manager of Meda. "With the introduction of EDLUAR sublingual tablets, patients with insomnia who have trouble falling asleep now have another treatment option. We are pleased to be the company that brings this innovative new formulation to these patients."
"Insomnia is a complex problem because patients can present with a variety of troubling symptoms," said Harry Sacks, M.D., vice president, medical affairs of Meda. "EDLUAR combines the efficacy and safety profile of zolpidem tartrate -- an agent used for 17 years -- with a new sublingual formulation that is convenient for patients with short-term insomnia whose primary complaint is the inability to fall asleep."
EDLUAR Instant Savings Program Now Available
Insured patients may be eligible for savings on co-payments for prescriptions of EDLUAR sublingual tablets. For eligible patients, Meda will cover 100% of the first co-pay for a prescription of EDLUAR sublingual tablets. Patients will pay their plans' co-pay amounts, up to $20, for four additional fills of EDLUAR sublingual tablets; the balance, if any, is covered by the EDLUAR Instant Savings Program. For more information including eligibility, exclusions and further details, please visit www.edluar.com.
Important Safety Information
Allergic reactions such as sudden trouble breathing, swelling of your tongue or throat may occur and in rare cases may be fatal. If you are allergic to zolpidem tartrate or any of EDLUAR's inactive ingredients, don't take this product. If you have an allergic reaction while using EDLUAR, do not take another dose and contact your doctor immediately.
In patients with depression, worsening of depression (including suicidal thoughts, actions and completed suicides) may occur. If your depression worsens, contact your doctor immediately.
Because EDLUAR works quickly, you should take EDLUAR immediately before going to bed. When taking EDLUAR, stay in bed for a full night (7 to 8 hours) before you must be active again. EDLUAR can be taken for 7 to 10 days or as advised by your doctor. If your sleep problems continue, consult your doctor, who will determine whether another condition is causing your sleep problem or other measures are needed to overcome your sleep problems.
You are encouraged to report side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.fda.gov/medwatch or call 1-800-FDA-1088 or contact Meda Pharmaceuticals Inc. at 1-800-526-3840.
Ambien(R) is a registered trademark of sanofi-aventis US LLC.
SOURCE Meda Pharmaceuticals Inc.
CONTACT: Anders Larnholt, VP Corporate Development & Investor Relations,
Meda, +46-709-458-878
Web site: http://www.meda.se/