Sonata is a sedative, also called a hypnotic. It affects chemicals in your brain that may be unbalanced in people with sleep problems (insomnia).

Sonata is used to treat insomnia.

Sonata causes relaxation to help you fall asleep and stay asleep.

Sonata may cause a severe allergic reaction. Stop taking this medicine 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.

Some people using Sonata have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. Serious injury or death could occur if you walk or drive while you are not fully awake. 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.

Do not drink alcohol while you are taking this medication. It can increase some of the side effects of zaleplon, including drowsiness.

Zaleplon may be habit-forming. Keep the medication in a place where others cannot get to it. MISUSE OF THIS MEDICATION CAN CAUSE ADDICTION OR OVERDOSE, especially in a child or other person using the medicine without a prescription. Selling or giving away Sonata is against the law.

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.

To make sure this medicine is safe for you, tell your doctor if you have ever been addicted to drugs or alcohol.

Take Sonata exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Zaleplon may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

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

Sonata is for short-term use only. Do not take this medicine for longer than 5 weeks without your doctor's advice.

Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

Do not stop using Sonata suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Insomnia symptoms may also return after you stop taking Sonata, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking this medicine.

Usual Adult Dose for Insomnia:

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 20 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia:

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 10 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

You should not use Sonata if you are allergic to zaleplon, or if you have ever taken sleep medicine and engaged in activity you later don't remember.

Sonata is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a breathing disorder;

• depression, mental illness, or suicidal thoughts; or

• drug or alcohol addiction.

You should not take zaleplon if you are pregnant.

You should not breastfeed while using zaleplon before speaking with your doctor.

The sedative effects of zaleplon 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.

Since Sonata is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medication if you do not have several hours to sleep before being active again.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zaleplon can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include severe drowsiness, confusion, loss of coordination, severe muscle weakness, weak or shallow breathing, fainting.

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 the equivalent of a full night's sleep after taking Sonata.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking Sonata with food or right after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medicine.

Zaleplon 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 medicine 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.

Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Sonata: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking Sonata and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;

• memory problems, unusual thoughts or behavior;

• thoughts of hurting yourself; or

• confusion, hallucinations (hearing or seeing things).

Common Sonata side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;

• feeling light-headed;

• problems with coordination; or

• numbness, tingling, weekness, or prickly feeling on your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Sonata with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.