Sonata 5 mg capsule

Generic name:
Zaleplon - oral

Pronunciation
(ZAL-e-plon)

Brand name(s)
Sonata

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous (possibly fatal) to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. You should not take this medication or similar medications (such as eszopiclone, zolpidem) if you have this reaction to the medication.

This medication is used for a short time to treat people who have trouble falling asleep. If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you. Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.

Read the Medication Guide provided by your pharmacist before you start taking zaleplon and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. Zaleplon works very quickly, so it is important to take it just before or when you get into bed. Your doctor will work with you to find the smallest dose that works for you.

Zaleplon should not be used for naps. Do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing anything that needs alertness, such as driving or operating machinery.

You should not eat a very heavy/high-fat meal within 2 hours before taking this medication since doing so may prevent the drug from working properly.

The dosage is based on your medical condition, age, and response to treatment. Since this medication is usually prescribed for a short time, your doctor will tell you when to stop taking it or when to cut back.

You may feel anxious or have trouble falling asleep in the first day or two after stopping this medication (rebound insomnia). Contact your doctor if you continue to have trouble falling asleep several days after stopping zaleplon.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as unusual depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, or seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zaleplon for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

Tell your doctor if your condition lasts or gets worse.

See also Warning section.

Dizziness, drowsiness, short-term memory loss, or lack of coordination may occur, especially during the first 2 hours after you take the medication. Taking the medication properly just before falling asleep will reduce your risk of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as agitation, confusion, seeing/hearing things that are not there, rare thoughts of suicide)
• unusual behavior

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking zaleplon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• very high/low blood pressure
• breathing problems (such as asthma)
• depression
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially memory problems, confusion, dizziness, lack of coordination. Dizziness and lack of coordination can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• melatonin
• sodium oxybate

Other medications can affect the removal of zaleplon from your body, which may affect how zaleplon works. Examples include azole antifungals (such as ketoconazole), cimetidine, rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as phenobarbital, phenytoin), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include confusion, loss of coordination, slow/shallow breathing, and loss of consciousness.

Do not share this medication with others. Sharing it is against the law.

Lifestyle changes may help improve your sleep (such as avoid drinking beverages containing caffeine close to bedtime or taking daytime naps). Consult your doctor or pharmacist for more details.

Not applicable.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.