Pronunciation:

lem-boe-REX-ant

Brand Names:

• Dayvigo

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Pharmacologic—

Orexin Receptor Antagonist

Uses of This Medicine:

Lemborexant is used to treat insomnia (sleeping problems). It belongs to the group of medicines called central nervous system (CNS) depressants. These medicines will slow down the nervous system. Lemborexant will help you get to sleep faster and sleep throughout the night. In most cases, sleep medicines should only be used for short periods of time, such as 1 or 2 days, and for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lemborexant in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lemborexant in the elderly. However, sleepiness, drowsiness, and falling are more likely to occur in the elderly, who are more sensitive than younger adults to the effects of lemborexant.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acepromazine
• Alfentanil
• Alprazolam
• Amiodarone
• Amobarbital
• Amprenavir
• Anileridine
• Apalutamide
• Aprepitant
• Aripiprazole
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Boceprevir
• Bosentan
• Bromazepam
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclophosphamide
• Cyclosporine
• Darunavir
• Delavirdine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Dronedarone
• Droperidol
• Efavirenz
• Elagolix
• Enflurane
• Enzalutamide
• Erythromycin
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Idelalisib
• Ifosfamide
• Imatinib
• Indinavir
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Larotrectinib
• Letermovir
• Levorphanol
• Lomitapide
• Lopinavir
• Lorazepam
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Mibefradil
• Midazolam
• Mifepristone
• Mitotane
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Omaveloxolone
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Palbociclib
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Remifentanil
• Remoxipride
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Secobarbital
• Sertindole
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Verapamil
• Voriconazole
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Dependence on lemborexant may develop.

• Breathing or lung problems (eg, COPD, sleep apnea) or
• Cataplexy (sudden onset of muscle weakness), history of or
• Depression, history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

• Narcolepsy (uncontrollable desire for sleep or a sudden attack of deep sleep)—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take lemborexant just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Lemborexant should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (at least 7 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Use this medicine only when you cannot sleep. You do not need to keep a regular schedule for taking it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of insomnia (trouble sleeping):
  • For oral dosage form (tablets):
    • Adults—5 milligrams (mg) once a day, at bedtime. Your doctor may increase your dose as needed and tolerated. However, the dose is usually no more than 10 mg per day.
    • Older adults—5 mg once a day, at bedtime.
    • Children—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you think you need to take lemborexant for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally, which may lead to falls, fractures, or other injuries. Even though lemborexant is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you develop any unusual and strange thoughts or behavior while you are using lemborexant, be sure to discuss it with your doctor. Some changes that have occurred in people using this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. You could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if any of these things occur.

This medicine may cause sleep paralysis (temporary inability to move or talk for up to several minutes while you are going to sleep or wake up) or have cataplexy-like symptoms (temporary weakness in your legs). Tell your doctor right away if you have these symptoms while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Sleepiness or unusual drowsiness

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual tiredness or weakness

Less common

Temporary inability to move or talk while you are going to sleep or waking up

Rare

Changes in behavior

discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

seeing, hearing, or feeling things that are not there

thoughts of killing oneself

trouble concentrating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.