Lemborexant is a sleep medicine that is used to treat insomnia (trouble falling asleep or staying asleep).

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

Take lemborexant right before you get into bed. Never take this medicine if you do not have 7 hours to sleep before being active again.

Your reactions may be impaired the morning after you take lemborexant. Do not drive or do anything that requires you to be alert. Drowsiness can cause falls, accidents, or severe injuries.

Follow the directions on your prescription label and read all medication guides. Never use lemborexant in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of lemborexant.

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

Take lemborexant only once per night, right before you get into bed.

Avoid taking the medicine shortly after eating a meal, or the medicine may take longer to work.

Lemborexant will make you fall asleep. Never take this medicine if you do not have 7 hours to sleep before being active again.

You may have trouble speaking or moving while you are falling asleep. It may take longer for you to wake up, speak, or move around when you wake up. You may feel like you are still dreaming for several minutes after waking.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using lemborexant for 7 to 10 nights in a row.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose for Insomnia:

5 mg orally once a day at bedtime
-Maximum dose: 10 mg once at bedtime

Use: For the treatment of patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

You should not use lemborexant if you have:

• narcolepsy; or

• severe liver disease.

Tell your doctor if you have ever had:

• depression, mental illness, or thoughts about suicide;

• drug or alcohol abuse or addiction;

• breathing problems, sleep apnea (breathing stops during sleep);

• liver or kidney disease;

• sudden muscle weakness;

• excessive sleepiness during normal waking hours; or

• if you have ever fallen asleep at unexpected times.

Tell your doctor if you are pregnant or breastfeeding.

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

Lemborexant is not approved for use by anyone younger than 18 years old.

Since lemborexant is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medicine if you do not have 7 hours to sleep before being active again.

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.

Your reactions may be impaired the morning after you take lemborexant. Do not drive or do anything that requires you to be alert. Drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

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

Some people using lemborexant have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Lemborexant may cause serious side effects. Call your doctor at once if you have:

• trouble moving or talking when you first wake up;

• a weak feeling in your legs;

• unusual thoughts or behavior;

• anxiety, agitation, depression;

• memory problems;

• confusion, hallucinations; or

• worsening depression or thoughts about hurting yourself.

Older adults have a higher risk of falls due to drowsiness caused by lemborexant.

Common side effects of lemborexant may include:

• drowsiness during the day after taking lemborexant.

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.

Using lemborexant 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.

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

Other drugs may affect lemborexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Lemborexant is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

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.