Generic Name: zaleplon (ZAL-e-plon)
Brand Name: Sonata

Sonata is used for:

Short-term treatment of insomnia.

Sonata is a hypnotic agent. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Sonata if:

  • you are allergic to any ingredient in Sonata
  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Sonata:

Some medical conditions may interact with Sonata. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, especially tartrazine dye or aspirin
  • if you have a history of depression or other mental illness, or alcohol or drug abuse; or if you are debilitated
  • if you have severe kidney or liver problems or a breathing disorder

Some MEDICINES MAY INTERACT with Sonata. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cimetidine or sodium oxybate (GHB) because an increase in sleep duration may occur
  • Carbamazepine, phenobarbital, phenytoin, or rifampin because they may decrease Sonata's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sonata may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sonata:

Use Sonata as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sonata comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sonata refilled.
  • Take Sonata by mouth with or without food.
  • Do not take Sonata with or right after a high-fat or heavy meal. Doing so may delay when the medicine will begin to work.
  • Sonata works very quickly. It should be taken immediately before going to bed or after you have gone to bed and are having trouble falling asleep.
  • Do not take Sonata unless you will be able to get 4 or more hours of sleep before you must be active again.
  • If you miss a dose of Sonata, take it when you remember if you are still able to get at least 4 hours of sleep. If you are no longer able to get at least 4 hours of sleep when you remember, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sonata.

Important safety information:

  • Sonata may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Sonata with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Continue to use caution the morning after taking Sonata.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sonata; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Common side effects, such as dizziness, lightheadedness, coordination problems, and memory problems, occur most often within 1 hour after taking Sonata. Be sure to take Sonata right before you to go to bed or after you are already in bed. This will help to decrease these side effects.
  • Some patients taking Sonata have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Sonata. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Sonata. Tell your doctor right away if such an event happens to you.
  • Sonata may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sonata. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • If your symptoms do not get better within 7 days or if they get worse, check with your doctor.
  • Tell your doctor or dentist that you take Sonata before you receive any medical or dental care, emergency care, or surgery.
  • This product may contain tartrazine dye (FD & C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • You may experience trouble sleeping for 1 to 2 nights after you stop taking Sonata. If it continues, contact your doctor.
  • Use Sonata with caution in the ELDERLY; they may be more sensitive to its effects.
  • Sonata should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Sonata while you are pregnant. Sonata is found in breast milk. Do not breast-feed while taking Sonata.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Sonata. This is known as DEPENDENCE or addiction.

If you stop taking Sonata suddenly, you may have WITHDRAWAL symptoms. These may include stomach and muscle cramps, vomiting, sweating, shakiness, and, rarely, seizures.

Possible side effects of Sonata:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; decreased sensitivity to touch; dizziness; drowsiness; incoordination; lightheadedness; muscle pain; short-term memory loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; agitation; bizarre behavior; changes in personality, mood, or behavior; daytime drowsiness; hallucinations; memory loss; shortness of breath; suicidal thoughts; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; depression; drowsiness; lethargy; loss of consciousness; loss of coordination; low blood pressure; slow, shallow breathing; sluggishness.

Proper storage of Sonata:

Store Sonata between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Protect from light, moisture, and heat. Do not store in the bathroom. Keep Sonata out of the reach of children and away from pets.

General information:

  • If you have any questions about Sonata, please talk with your doctor, pharmacist, or other health care provider.
  • Sonata is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Sonata or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sonata. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sonata. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Sonata.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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