Daridorexant Oral Tablets

What is this medication?

DARIDOREXANT (DAR i doe REX ant) treats insomnia. It helps you go to sleep faster and stay asleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): QUVIVIQ

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

They need to know if you have any of these conditions:

• Depression
• History of drug abuse or addiction
• History of a sudden onset of muscle weakness (cataplexy)
• History of falling asleep often at unexpected times (narcolepsy)
• If you often drink alcohol
• 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; a previous suicide 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

How should I use this medication?

Take this medication by mouth with water 30 minutes before going to bed. Follow the directions on the prescription label. It is better to take this medication on an empty stomach. Do not take your medication more often than directed.

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.

What may interact with this medication?

• Alcohol
• Antihistamines for allergy, cough, or cold
• Bosentan
• Certain antibiotics like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medicines for depression, anxiety, or psychotic disorders
• Certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medicines for seizures like carbamazepine, phenytoin, phenobarbital
• Diltiazem
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Grapefruit juice
• Medicines that relax muscles for surgery
• Narcotic medicines for pain
• Other medicines for sleep
• 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.

After taking this medication, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Stop the medication and call your care team right away if you find out you have done any of these activities. Do not take this medication if you have used alcohol that evening. Do not take it if you have taken another medication for sleep. The risk of doing these sleep-related activities is higher.

Do not take this medication unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. Tell your care team if you will need to perform activities requiring full alertness, such as driving, the next day. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Do not stand or sit up quickly after taking this medication, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or 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 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
• 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
• Temporary inability to move or talk for up to several minutes while you are going to sleep or waking up
• 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
• Headache
• Tiredness

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.

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.