Intermezzo contains zolpidem tartrate, a non-benzodiazepine hypnotic from the imidazopyridine class. It is formulated as sublingual tablets available in strengths of 1.75 mg and 3.5 mg. These tablets are placed under the tongue for administration. Key inactive ingredients include crospovidone, povidone, mannitol, and sodium bicarbonate. Intermezzo is designed for sublingual administration, where the tablets disintegrate under the tongue.

How should I use this medication?

Take this medication as directed on the prescription label. Place this medication under your tongue and let it dissolve. Do not swallow it or take it with water. Take this medication on an empty stomach. Do not take your medication more often than directed. If you have been taking this medication for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your care team may want to slowly lower the dose. Do not stop taking this medication on your own. Always follow your care team's advice. Edluar brand: This medication will help you fall asleep. You will only take the medication right before you get into bed. Take only when you are able to stay in bed a full night (7 to 8 hours) before being active again. Intermezzo brand: This medication is used to help you return to sleep after waking in the middle of the night. Only take it if you have at least 4 hours of bedtime remaining. Place a single Intermezzo pouch by your bed. Store all other unopened Intermezzo pouches and other medications away from your bedside. Only open the Intermezzo pouch when you are ready to use it. If needed, use one of the dosing time tools that come with your prescription to find the latest time of night you can take your dose. After taking the dose, leave the empty medication pouch where you can see it to help remind you that the dose has already been taken. Throw the empty pouch away in the morning. 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. People 65 years and older may have a stronger reaction and need a smaller dose.

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 medication should only be taken immediately before going to sleep (Edluar brand) or when you have trouble returning to sleep after waking in the middle of the night (Intermezzo brand). You will only take one dose per night. 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 and moisture. 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 -Headache

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 -Frequently drink alcohol -Liver disease -Lung or breathing disease -Myasthenia gravis -Sleep apnea -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 zolpidem, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Alcohol -Antihistamines for allergy, cough, and cold -Certain medications for anxiety or sleep -Certain medications for depression, such as amitriptyline, fluoxetine, sertraline -Certain medications for fungal infections, such as ketoconazole and itraconazole -Certain medications for seizures, such as phenobarbital, primidone -Ciprofloxacin -Dietary supplements for sleep, such as valerian or kava kava -General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol -Local anesthetics, such as lidocaine, pramoxine, tetracaine -Medications that relax muscles for surgery -Opioid medications for pain -Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine -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. Talk to your care team if your insomnia worsens or is not better within 7 to 10 days. 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. When using this medication for help with trouble falling asleep (Edluar tablets), do not take it unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. When using this medication for middle-of-the-night awakening (Intermezzo tablets), do not take it with less than 4 hours of bedtime remaining. 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. This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression. 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.