Sonata Patient Information

Brand Name: Sonata
Generic Name: Zaleplon

Sonata (zaleplon) full prescribing information

What is Sonata?

Sonata is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Sonata is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

Important information about Sonata

Sonata may cause a severe allergic reaction. Stop taking Sonata and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Sonata will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking this medication and talk with your doctor about another treatment for your sleep disorder.

Sonata can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking this medication. It can increase some of the side effects of Sonata, including drowsiness. Sonata may be habit-forming and should be used only by the person it was prescribed for. Sonata should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking this medication after taking it over several days in a row. Do not stop taking Sonata suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Before taking Sonata

Sonata will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Sonata and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to zaleplon.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• sleep apnea (breathing stops while you are asleep);
• lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
• a history of depression, mental illness, or suicidal thoughts; or
• a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Sonata.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sonata can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of Sonata may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Sonata.

Sonata may be habit-forming and should be used only by the person it was prescribed for. Sonata should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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How should I take Sonata?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Sonata only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Take this medication with a full glass of water.

Avoid taking Sonata within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Sonata is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Sonata for longer than 2 weeks without your doctor's advice.

You may have withdrawal symptoms if you stop taking Sonata after taking it over several days in a row. Do not stop taking Sonata suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store this medication at room temperature away from moisture and heat. Keep track of how many capsules have been used from each new bottle of this medicine. Sonata is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since Sonata is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have at least 4 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking Sonata?

Sonata can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking this medication. It can increase some of the side effects of Sonata, including drowsiness. Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

Avoid taking Sonata during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get at least 4 hours of sleep after taking Sonata.

Sonata side effects

Sonata may cause a severe allergic reaction. Stop taking Sonata and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;
• thoughts of hurting yourself; or
• hallucinations (hearing or seeing things).

Less serious side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;
• problems with memory or concentration;
• numbness or tingling;
• anxiety, depression, nervous feeling;
• problems with vision;
• headache;
• nausea, stomach pain, loss of appetite, constipation;
• dry mouth;
• increased menstrual pain (cramps);
• back pain, joint or muscle pain; or
• mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sonata?

Before taking Sonata, tell your doctor if you are taking any of the following drugs:

• cimetidine (Tagamet)
• thioridazine (Mellaril)
• promethazine (Phenergan, Promacot)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• rifampin (Rifadin, Rifater, Rifamate, Rimactane)
• antibiotics such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral)
• antidepressants such as imipramine (Janimine, Tofranil), fluoxetine (Prozac, Sarafem), or sertraline (Zoloft)
• narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications.

This list is not complete and there may be other drugs that can interact with Sonata. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Sonata.

What does my medication look like?

Zaleplon is available with a prescription under the brand name Sonata. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Sonata 5 mg - green capsules
• Sonata 10 mg - green capsules

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Sonata (zaleplon) full prescribing information

Last Updated: 11/2007

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