Dayvigo: Uses, Side Effects and Dosage

What DAYVIGO is used for:

DAYVIGO is used in adults who have trouble falling asleep and/or staying asleep (insomnia).

DAYVIGO is not for use in children under the age of 18 years.

How DAYVIGO works:

DAYVIGO belongs to a group of medicines called “orexin receptor antagonists”. Orexins are substances that bind to certain receptors in your brain to keep you awake. DAYVIGO temporarily blocks these receptors. This may help you fall asleep faster and stay asleep.

The ingredients in DAYVIGO are:

Medicinal ingredient: lemborexant.

Non-medicinal ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains the following non-medicinal ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and

• for the 5 mg tablet: ferric oxide yellow.
• for the 10 mg tablet: ferric oxide red and ferric oxide yellow.

DAYVIGO comes in the following dosage forms:

Film-coated tablet: 5 mg and 10 mg.

Do not use DAYVIGO if:

• you are allergic to lemborexant, or any of the other ingredients of DAYVIGO.
• you have narcolepsy (a sleep disorder that causes excessive daytime sleepiness and causes you to fall asleep often at unexpected times).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DAYVIGO. Talk about any health conditions or problems you may have, including if you:

• have a history of drug or alcohol abuse or addiction.

• have a history of sleeping problems such as falling asleep often at unexpected times (narcolepsy) or feeling sleepy during the day.
• have lung or breathing problems.
• have liver problems.

• are pregnant or plan to become pregnant. It is not known if DAYVIGO can harm your unborn baby. Your healthcare professional will decide whether prescribing DAYVIGO to you outweighs the risk to your unborn baby.

• are breast-feeding or plan to breast-feed. DAYVIGO can pass into your breast milk.
• are lactose intolerant.

Other warnings you should know about:

Abnormal thinking and behavioural changes: When taking a sleep medication, such as DAYVIGO, you may experience abnormal thinking and changes to your behaviour. These can include:

• memory loss (amnesia) for events that occur when you are not fully awake.
• anxiety.
• seeing or hearing things that are not there (hallucinations) when falling asleep or waking up.

Complex sleep-related behaviours: While taking a sleep medication, such as DAYVIGO, you may get out of bed while not being fully awake and do activities that you do not know you are doing, such as:

• sleepwalking.
• driving a car (“sleep-driving”).
• eating.
• making phone calls.
• having sex.

The next morning you may not remember what you did during the night. If someone tells you about events you do not remember doing, or you think you may have done things in your sleep you do not remember doing, stop taking DAYVIGO and call your healthcare professional.

You increase your risk of doing activities while not fully awake if you:

• drink alcohol.
• take other medicines that make you feel sleepy.
• have other conditions that affect your sleep that can cause you to wake up often during the night (such as sleep apnea, Periodic Limb Movement Disorder or Restless Leg Syndrome).

Worsening depression and thoughts of suicide: Thoughts of suicide have been reported in people taking DAYVIGO. Some people with depression who took sleep medications saw their depression get worse. They also had increased thoughts of suicide and actions. If you, your caregiver or your family members notice that your depression is getting worse or that you are having thoughts of suicide call your healthcare professional right away.

Sleep paralysis, muscle weakness (cataplexy), and hallucinations: You may experience the following when taking DAYVIGO:

• you are not able to move or talk for up to several minutes while you are going to sleep or waking up (“sleep paralysis”).
• have sudden muscle weakness, commonly in the legs, that can last a few seconds to a few minutes (cataplexy-like symptoms). This can happen during the day or at night and may not be associated with an identified triggering event (e.g., laughter or surprise).
• seeing or hearing things that are not there (hallucinations) while falling asleep or when you wake up.

If you experience any of these, talk to your healthcare professional.

Driving and using machines: DAYVIGO may affect your ability to be alert the next day.

It may affect how well you drive and you may be at an increased risk of falling asleep while you drive. Do NOT drive or use dangerous machinery until you know how taking DAYVIGO affects you the next day.

You can feel less alert:

• even if you take DAYVIGO exactly as prescribed.
• for several days after you stop taking it.

You increase the risk of being less alert the next day if:

• you do NOT get a full night of sleep (at least 7 hours).
• take DAYVIGO with other medicines that make you sleepy.
• are taking a higher dose.

If you notice that you are feeling more sleepy or drowsy during the day and it is affecting your ability to do tasks that require clear thinking or attention, talk to your healthcare professional.

Falls: Since DAYVIGO can cause you to feel drowsy, you may be at a higher risk of falls, especially if you are older.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DAYVIGO:

• alcohol, as it can increase your chances of getting serious side effects. Do NOT drink any alcohol while taking DAYVIGO.

• sedatives (that can make you sleepy). Do NOT take any sedatives or medicines that can make you sleepy. This includes:

  • prescription and over-the-counter sleep products.
  • opioids (used to treat pain).
  • certain antidepressants (used to treat depression).
• itraconazole, ketoconazole and posaconzole (used to treat fungal infections).
• clarithromycin, telithromycin (used to treat bacterial infections).
• bocepravir, telaprevir (used to treat Hepatitis C Virus (HCV)).
• fluconazole (used to treat fungal and yeast infections).
• diltiazem and verapamil (used to treat high blood pressure and chest pain/angina).
• digoxin (used to treat heart failure).
• aprepitant (used to treat nausea and vomiting caused by certain anti-cancer medicines).
• imatinib (used to treat certain types of cancer).
• nefazodone (used to treat depression).
• conivaptan (used to treat low sodium levels).
• rifampin (used to treat bacterial infections).
• carbamazepine and phenytoin (used to treat convulsions and seizures).
• St. John’s wort (used to treat depression).
• grapefruit juice.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare professionals each time you get a new medicine.

How to take DAYVIGO:

Take DAYVIGO:

• exactly how and for as long as your healthcare professional has told you to take it.
• once a day at night within a few minutes before going to bed.
• only when you can get a full night of sleep (at least 7 hours).

DAYVIGO may take longer to work if you take it with or soon after eating a meal.

Talk to your healthcare professional if after 7 to 10 days of taking DAYVIGO your sleep problems get worse or are not better. This may mean that there is another condition causing your sleep problems.

Usual dose:

The recommended daily dose: 5 mg once a day (within a few minutes of going to bed, and with at least 7 hours remaining before you plan to wake up).

The maximum recommended dose: 10 mg once a day (within a few minutes of going to bed and with at least 7 hours remaining before you plan to wake up).

Do NOT take more than 10 mg a day.

Your healthcare professional may change your dose depending on how you respond to DAYVIGO.

Overdose:

Missed Dose:

• If you miss a dose and you do have time to sleep for at least 7 hours before you must wake up again, take your dose as usual.
• If you do not have time to sleep for at least 7 hours before you must wake up again: Do NOT take your dose. Take it the next night.

Possible side effects from using DAYVIGO:

These are not all the possible side effects you may have when taking DAYVIGO. If you experience any side effects not listed here, tell your healthcare professional.

The side effects of DAYVIGO include:

• Sleepiness during the day.
• Headache.
• Nasopharyngitis.
• Fatigue.
• Urinary tract infection.
• Nausea.
• Upper respiratory tract infection.
• Back pain.
• Nightmares.
• Abnormal dreams.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store DAYVIGO:

• at room temperature (15°C - 30°C).
• in the original bottle with the child-resistant closure.
• Do not use this medicine after the expiry date on the bottle.

Keep out of reach and sight of children.

If you want more information about DAYVIGO:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website eisai.ca, or by calling 1-877-873-4724.

DAYVIGO® is a registered trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc.

Last Revised: 2025-01-30