Sonata contains the active ingredient zaleplon, a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. It is formulated as a capsule available in 5 mg or 10 mg strengths for oral use. Key inactive ingredients include colloidal silicon dioxide, lactose (anhydrous), and magnesium stearate. Sonata is designed to help with sleep by acting on the central nervous system.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the label. Do not use it more often than directed. There may be unused or extra doses in the bottle after you finish your treatment. Talk to your care team if you have questions about your dose. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication should only be taken immediately before going to sleep. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. This medication may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision such as blurry vision, seeing halos around lights, vision loss -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, difficulty staying awake -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression -Unusual sleep behaviors or activities you do not remember such as driving, eating, or sexual activity Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Dizziness -Drowsiness the day after use -Pain, tingling, or numbness in the hands or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Depression -Liver disease -Lung or breathing disease -Substance use disorder -Suicidal thoughts, plans, or attempt by you or a family member -Unusual sleep behaviors or activities you do not remember -An unusual or allergic reaction to zaleplon, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Barbiturate medications for inducing sleep or treating seizures -Carbamazepine -Certain medications for allergies, such as azatadine, clemastine, diphenhydramine -Certain medications for mental health conditions -Certain medications for pain -Cimetidine -Erythromycin -Medications for fungal infections, such as ketoconazole, fluconazole, or itraconazole -Other medications given for sleep -Phenytoin -Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medications are used every night for more than a few weeks, they may stop working. Talk to your care team if you still have trouble sleeping. You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this. Plan to go to bed and stay in bed for a full night (7 to 8 hours) after you take this medication. You may still be drowsy the morning after taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away. After you stop taking this medication, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What are the most serious risks of this medication?

This medicine may cause you to do activities while you are not fully awake. You may not remember doing these activities the next morning. Activities such as driving a car, eating, talking on the phone, sexual activity, or sleep-walking can happen. Rarely, serious injuries or death have occurred. Stop taking the medicine and call your healthcare professional right away if you have any of these effects.