Daridorexant is used in adults who have trouble staying or falling asleep (insomnia).

Daridorexant may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking daridorexant. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Some people using daridorexant have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Tell your doctor if you feel an increased urge to use more of this medicine.

Daridorexant may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Take daridorexant 30 minutes before going to bed only once every night.

Only take daridorexant if you can stay at least 7 hours in bed before being active again.

If daridorexant is taken with or right after a meal, this medicine may take longer to work.

Call your doctor if your sleep problem worsens or does not improve within 7 to 10 days.

Keep your medicine in a place where no one can use it improperly.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Insomnia:

Recommended dose: 25 to 50 mg once per night, orally
Maximum dose: 50 mg

Comments:
-Take no more than once per night within 30 minutes of going to bed, and with at least 7 hours remaining prior to awakening.
-The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric or medical illness that should be evaluated.

Use: Treatment of adults with insomnia

You should not use daridorexant if you fall asleep often (narcolepsy).

Tell your doctor if you have ever had:

• mental illness, depression, or suicidal thoughts;

• drug or alcohol abuse or addiction;

• a condition called cataplexy (sudden onset of muscle weakness);

• daytime sleepiness;

• breathing problems, including sleep apnea (breathing that stops during sleep); or

• liver problems.

It is not known if daridorexant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of daridorexant on the baby.

Ask a doctor if it is safe to breastfeed while using daridorexant.

Take the medicine as soon as you can if you take daridorexant on a regular basis. Do not take more than one dose in the same day. Skip the missed dose and go back to your normal dosing schedule if you will not be able to stay in bed for at least 7 hours after taking the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how daridorexant will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or have thoughts about suicide or hurting yourself.

Some people using daridorexant have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Call your doctor at once if you have an inability to move or talk for several minutes or if you have hallucinations while you are waking up or going to sleep.

Common side effects of daridorexant may include:

• headache; and

• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Using daridorexant with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect daridorexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.