Class Name(s):

• 28:24.40 Orexin Receptor Antagonists

Pronunciation:

• (lem'' boe rex' ant)

Brand Name(s):

• Dayvigo^®

WHY is this medicine prescribed?

Lemborexant is used to treat insomnia (difficulty falling asleep or staying asleep). Lemborexant belongs to a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.

HOW should this medicine be used?

Lemborexant comes as a tablet to take by mouth. It is usually taken as needed, not more than one time a day, immediately before bedtime. Lemborexant will work faster if it is not taken with a meal or immediately after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lemborexant exactly as directed.

You will probably become very sleepy soon after you take lemborexant and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take lemborexant and to stay in bed for at least 7 hours. Do not take lemborexant if you will be unable to go to bed right away and remain asleep for at least 7 hours after taking the medication.

You should be sleeping well within 7 to 10 days after you start taking lemborexant. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.

Lemborexant may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lemborexant and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking lemborexant,

• tell your doctor and pharmacist if you are allergic to lemborexant, any other medications, or any of the ingredients in lemborexant tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may tell you not to take lemborexant, may need to change the doses of your medications, or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with lemborexant: ranitidine, St. John's wort, and sleeping pills. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lemborexant. Do not start any of these medications while taking lemborexant without talking to your healthcare provider.
• tell your doctor if you have narcolepsy (a condition that causes excessive daytime sleepiness). Your doctor will probably tell you not to take lemborexant.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had depression; mental illness; thoughts of harming or killing yourself or trying to do so; a problem with heavy snoring; sleep apnea (condition in which breathing briefly stops many times during the night); other breathing problems or lung diseases such as asthma, bronchitis, and emphysema; cataplexy (episodes of muscle weakness that begin suddenly and last for a short time); or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lemborexant, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lemborexant.
• you should know that this medication may cause drowsiness, decreased mental alertness, prolonged reaction time, problems with coordination the day after you take it, blurry or double vision, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Your ability to drive or operate machinery the day after you take lemborexant may be impaired even if you feel fully awake. Do not drive a car or operate machinery until you know how lemborexant affects you.
• do not drink alcohol during your treatment with lemborexant. Alcohol can make the side effects of lemborexant worse.
• you should know that lemborexant has caused serious or possibly life-threatening sleep behaviors. Some people who took lemborexant got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, sleep-walked, or were involved in other activities while not fully awake. After they woke up, these people were unable to remember what they had done. These activities may occur with lemborexant whether or not you drink alcohol or also take other sleep medications. Call your doctor right away if you have ever had an unusual sleep behavior while taking lemborexant.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

Lemborexant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• tiredness
• headache
• vivid, unusual dreams or nightmares

Some side effects can be serious. If you experience any of these symptoms, stop taking lemborexant and call your doctor immediately:

• temporary inability to move or talk while you are going to sleep or waking up (sleep paralysis)
• sudden and temporary weakness of legs
• new or worsening depression or anxiety
• thoughts of suicide, dying, or hurting yourself, or planning or trying to do so
• sudden onset of muscle weakness
• pounding heartbeat

Lemborexant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness

What should I know about STORAGE and DISPOSAL of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2023.