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Sonata®

Brand Name: Sonata®
Active Ingredient:   zaleplon
Strength(s): 5mg and 10mg
Dosage Form(s):   Capsule
Availability:         Prescription only
Company Name:    Wyeth-Ayerst Laboratories
*Date Approved by FDA: August 13, 1999
*Approval by FDA does not mean that the drug is available to consumers at this time.




What is Sonata used for?

Sonata is used to treat short-term difficulty in falling asleep. Sonata has been shown to decrease the time to sleep onset for up to 28 days in clinical studies. Sonata 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.

General Precautions with Sonata: 

  • Sonata, like all sleep medicines, may make you drowsy during the day. The amount of drowsiness you feel depends upon how your body reacts to Sonata and the dose of Sonata 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 Sonata, they may be due to another medical reason. Tell your doctor right away.
  • If you abruptly stop taking Sonata you may experience withdrawal symptoms.
  • You may have more trouble falling asleep the first few nights after you stop taking Sonata than before starting Sonata, (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 Sonata 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 Sonata 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 Sonata, tell your doctor.
  • There is a risk of becoming dependent on Sonata, as with any sleeping medication. However, if you have a history of addiction to alcohol or drugs your risk of your becoming dependent on Sonata is higher. Be sure to tell your doctor about any previous addictions to alcohol or drugs before you start taking Sonata.
  • Until you know if Sonata 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 Sonata or any other sleep medication. Alcohol can increase the side effects of Sonata.

What should I tell my doctor or health care 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 Sonata, review all medications that you are taking with your doctor, or health care provider, including those you take without a prescription.

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Sonata 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 Sonata is right for you.

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

  • Drowsiness
  • Dizziness
  • Lightheadedness
  • Difficulty with coordination

For more detailed information about Sonata, ask your health care provider.

http://www.fda.gov/cder/foi/label/1999/20859lbl.pdf    Link to Sonata's Approved Label

Posted 1/10/00
Updated 5/12/00
Revised 7/11/01

 

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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