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.
This product is available in the following dosage forms:
Tablet
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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