QUVIVIQ contains daridorexant as the active ingredient in the form of daridorexant hydrochloride salt, which acts as an orexin receptor antagonist. The drug is available as film-coated tablets in strengths of 25 mg and 50 mg for oral use. Key inactive ingredients include croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and povidone.

How should I use this medication?

Take this medication by mouth with water 30 minutes before going to bed. Take it as directed on the prescription label. It is better to take this medication on an empty stomach. 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 as directed 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 it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law. Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression -Sudden and temporary muscle weakness -Unable to move or speak for several minutes upon waking or going to sleep -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 these to your care team if they continue or are bothersome): -Drowsiness the day after use -Fatigue -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 -History of a sudden onset of muscle weakness (cataplexy) -History of falling asleep often at unexpected times (narcolepsy) -History of substance use disorder -Liver disease -Lung or breathing disease -Sleep apnea -Sleep-walking, driving, eating or other activity while not fully awake after taking a sleep medication -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to daridorexant, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Alcohol -Benzodiazepines, such as alprazolam, diazepam, or lorazepam -Bosentan -Certain antibiotics, such as erythromycin or clarithromycin -Certain antihistamines -Certain antivirals for HIV or hepatitis -Certain medications for depression, anxiety, or mental health conditions -Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole -Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital -Diltiazem -Grapefruit juice -Medications that cause drowsiness before a procedure, such as propofol -Medications that relax muscles -Opioids for pain or cough -Other medications that help you fall asleep -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Rifampin -St. John's wort -Verapamil

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. 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. Watch for new or worsening 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.