Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.
Zaleplon Capsules are the generic version of King Pharmaceuticals' Sonata(R) Capsules, which had U.S. sales of approximately $88 million for the 12 months ending March 31, 2008, according to IMS Health.
This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.
This is a summary of the most important information about Zaleplon. For details, talk to your healthcare professional.
What is Zaleplon used for?
Zaleplon is used to treat short-term difficulty in falling asleep. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in clinical studies. Zaleplon has not been shown to increase your total sleep time or decrease the number of times you wake up after falling asleep.
In general, medications used to bring on sleep should only be used for 7- 10 days.
Who should not take Zaleplon?
Do not take Zaleplon if you are allergic to Zaleplon or any of its ingredients. Zaleplon contains FD&C Yellow No. 5 dye (tartrazine) which may cause allergic reactions in certain people such as asthma-like symptoms and difficulty breathing. Patients who are allergic to aspirin may be more likely to have a reaction to Zaleplon.
General Precautions with Zaleplon: