Your doctor has prescribed Sonata to help you sleep. The following information is intended to guide you in the safe use of this medicine. It is not meant to take the place of your doctor's instructions. If you have any questions about Sonata capsules, be sure to ask your doctor or pharmacist. 

Sonata is used to treat difficulty in falling asleep. Sonata works very quickly and has its effect during the first part of the night, since it is rapidly eliminated by the body. You should take Sonata immediately before going to bed or after you have gone to bed and are having difficulty falling asleep. If your principal sleep difficulty is awakening prematurely after falling asleep, there is no evidence that Sonata will be helpful to you. For Sonata to help you fall asleep you should not take it with or immediately after a high-fat/heavy meal. 

Sonata belongs to a group of medicines known as the “hypnotics”, or simply, sleep medicines. There are many different sleep medicines available to help people sleep better. Sleep problems are usually temporary, requiring treatment for only a short time, usually 1 or 2 days up to 1 or 2 weeks. Some people have chronic sleep problems that may require more prolonged use of sleep medicine. However, you should not use these medicines for long periods without talking with your doctor about the risks and benefits of prolonged use. 

Who should not take Sonata

Do not take Sonata if you are hypersensitive to its active substance, zaleplon, or to any of its inactive ingredients, including tartrazine (FD&C Yellow No. 5). 

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 

Side Effects

All medicines have side effects. The most common side effects of sleep medicines are: 

  * Drowsiness 
  * Dizziness 
  * Lightheadedness 
  * Difficulty with coordination 



These side effects with Sonata occur most often within an hour after taking it, so it is especially important to take it only when you are about to go to bed or are already in bed. 

Severe allergic reactions, sometimes with difficulty in breathing and possibly life threatening, have been reported and may require immediate medical care. 

Sleep medicines can make you sleepy during the day. How drowsy you feel depends upon how your body reacts to the medicine, which sleep medicine you are taking, and how large a dose your doctor has prescribed. Daytime drowsiness is best avoided by taking the lowest dose possible that will still help you sleep at night. Your doctor will work with you to find the dose of Sonata that is best for you. Sonata generally does not cause next-day sleepiness but a few people have reported this. 

To manage these side effects while you are taking this medicine: 

\- When you first start taking Sonata or any other sleep medicine, until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft. - NEVER drink alcohol while you are being treated with Sonata or any sleep medicine. Alcohol can increase the side effects of Sonata or any other sleep medicine. - Do not take any other medicines without asking your doctor first. This includes medicines you can buy without a prescription. Some medicines can cause drowsiness and are best avoided while taking Sonata. - Always take the exact dose of Sonata prescribed by your doctor. Never change your dose without talking to your doctor first. 

Special Concerns

There are some special problems that may occur while taking sleep medicines. 

Memory Problems

Sleep medicines may cause a special type of memory loss or “amnesia.” When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine. Memory loss can be a problem, however, when sleep medicines are taken while traveling, such as during an airplane flight and the person wakes up before the effect of the medicine is gone. This has been called “traveler's amnesia.” Memory problems are not common while taking Sonata. In most instances memory problems can be avoided if you take Sonata only when you are able to get 4 or more hours of sleep before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems. 

Tolerance

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as “tolerance.” Development of tolerance to Sonata has not been observed in outpatient clinical studies of up to 4 weeks in duration; however, it is unknown if the benefits of Sonata in falling asleep more quickly persist beyond 4 weeks. Sleep medicines should, in most cases, be used only for short periods of time, such as 1 or 2 days and generally no longer than 1 or 2 weeks. If your sleep problems continue, consult your doctor, who will determine whether other measures are needed to overcome your sleep problems. 

Dependence 

Sleep medicines can cause dependence, especially when these medicines are used regularly for longer than a few weeks or at high doses. Some people develop a need to continue taking their medicines. This is known as dependence or “addiction.” 

When people develop dependence, they may have difficulty stopping the sleep medicine. If the medicine is suddenly stopped, the body is not able to function normally and unpleasant symptoms (see Withdrawal) may occur. They may find they have to keep taking the medicine either at the prescribed dose or at increasing doses just to avoid withdrawal symptoms. 

All people taking sleep medicines have some risk of becoming dependent on the medicine. However, people who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. This possibility must be considered before using these medicines for more than a few weeks. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting Sonata or any sleep medicine. 

Withdrawal

Withdrawal symptoms may occur when sleep medicines are stopped suddenly after being used daily for a long time. In some cases, these symptoms can occur even if the medicine has been used for only a week or two. In mild cases, withdrawal symptoms may include unpleasant feelings. In more severe cases, abdominal 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 the relatively limited controlled trials experience with Sonata, there is, nevertheless, the risk of such events in association with the use of any sleep medicines. 

Another problem that may occur when sleep medicines are stopped is known as “rebound insomnia.” This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights. 

If you have been taking Sonata or any other sleep medicine for more than 1 or 2 weeks, do not stop taking it on your own. Always follow your doctor's directions. 

Changes In Behavior and Thinking

Some people using sleep medicines have experienced unusual changes in their thinking and/or behavior. These effects are not common. However, they have included: 

\- more outgoing or aggressive behavior than normal - loss of personal identity - confusion - strange behavior - agitation - hallucinations - worsening of depression - suicidal thoughts 

How often these effects occur depends on several factors, such as a person's general health, the use of other medicines, and which sleep medicine is being used. Clinical experience with Sonata (zaleplon) suggests that it is uncommonly associated with these behavior changes. 

It is also important to realize that it is rarely clear whether these behavior changes are caused by the medicine, an illness, or occur on their own. In fact, sleep problems that do not improve may be due to illnesses that were present before the medicine was used. If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor immediately. 

Pregnancy and Breastfeeding

Sleep medicines may cause sedation or other potential effects in the unborn baby when used during the last weeks of pregnancy. Therefore, Sonata is not recommended for use during pregnancy. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Sonata. 

In addition, a very small amount of Sonata may be present in breast milk after use of the medication. The effects of very small amounts of Sonata on an infant are not known; therefore, as with all other hypnotics, it is recommended that you not take Sonata if you are breastfeeding a baby. 

Safe Use of Sleeping Medicines

To ensure the safe and effective use of Sonata or any other sleep medicine, you should observe the following cautions: 

  1. Sonata is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor's instructions about how to take, when to take, and how long to take Sonata. 
  2. Never use Sonata or any other sleep medicine for longer than directed by your doctor. 
  3. If you notice any unusual and/or disturbing thoughts or behavior during treatment with Sonata or any other sleep medicine, contact your doctor. 
  4. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking Sonata or any other sleep medicine. 
  5. Do not take Sonata unless you are able to get 4 or more hours of sleep before you must be active again. 
  6. Do not increase the prescribed dose of Sonata or any other sleep medicine unless instructed by your doctor. 
  7. When you first start taking Sonata or any other sleep medicine, until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft. 
  8. Be aware that you may have more sleeping problems the first night or two after stopping any sleep medicine. 
  9. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, if you become pregnant, or are breastfeeding a baby while taking Sonata. 
  10. As with all prescription medicines, never share Sonata or any other sleep medicine with anyone else. Always store Sonata or any other sleep medicine in the original container and out of reach of children. 
  11. Be sure to tell your physician if you suffer from depression. 
  12. Sonata works very quickly. You should only take Sonata immediately before going to bed or after you have gone to bed and are having difficulty falling asleep. 
  13. For Sonata to work best, you should not take Sonata with or immediately after a high-fat/heavy meal. 
  14. Some people should start with the lowest dose (5 mg) of Sonata; these include the elderly (ie, ages 65 and over) and people with liver disease. 



Prescribing Information as of March 2006.

Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620  
Manufactured by: Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101