Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

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Jun 9 2008

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:

Zaleplon, like all sleep medicines, may make you drowsy during the day. The amount of drowsiness you feel depends upon how your body reacts to Zaleplon and the dose of Zaleplon you are taking. If you experience drowsiness during the day, talk to your doctor.

If your sleep problems do not get better or you begin to have unusual thinking or behavior changes while you take Zaleplon, they may be due to another medical reason. Tell your doctor right away.

If you abruptly stop taking Zaleplon you may experience withdrawal symptoms.

You may have more trouble falling asleep the first few nights after you stop taking Zaleplon than before starting Zaleplon, (rebound insomnia). This problem usually goes away on its own after 1-2 nights.

Withdrawal symptoms may occur when sleep medicines are stopped suddenly after being used daily for a long time. In some cases, withdrawal symptoms may include unpleasant feelings. In severe cases, stomach and muscle cramps, vomiting, sweating, shakiness, and rarely seizures may occur. These more severe withdrawal symptoms are very uncommon. Although withdrawal symptoms have not been observed in studies of Zaleplon so far, there is, nevertheless, the risk of such events in association with the use of any sleep medicines.

There is a chance that you may experience a certain type of memory loss (amnesia). This can usually be avoided by taking Zaleplon only when you are able to get 4 or more hours of sleep before you need to be active again. If you do have memory problems while taking Zaleplon, tell your doctor.

There is a risk of becoming dependent on Zaleplon, as with any sleeping medication. However, if you have a history of addiction to alcohol or drugs your risk of your becoming dependent on Zaleplon is higher. Be sure to tell your doctor about any previous addictions to alcohol or drugs before you start taking Zaleplon.

Until you know if Zaleplon causes you drowsiness during the day, be extremely careful while doing anything that requires your complete attention, or physical coordination, like driving a car, or operating machinery.

Never drink alcohol while you are taking Zaleplon or any other sleep medication. Alcohol can increase the side effects of Zaleplon.

What should I tell my doctor or healthcare provider?

Tell your doctor if you or your family notice any changes in your thinking, or any new behaviors. Some people using sleep medications have experienced:

More outgoing or aggressive behavior than normal
Change in personality
Confusion
Strange behavior
Agitation
Hallucinations
Worsening of depression
Suicidal thoughts

Because certain other medications can interact with Zaleplon, review all medications that you are taking with your doctor, or healthcare provider, including those you take without a prescription.

Tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Zaleplon is not recommended during pregnancy or nursing.

Tell your doctor if you have or have had a history of liver problems. Your doctor will evaluate and decide Zaleplon is right for you.

What are some possible side effects of Zaleplon? (This is NOT a complete list of side effects reported with Zaleplon. Your healthcare provider can discuss with you a more complete list of side effects.)