Dayvigo

Dayvigo (lemborexant) is a sleeping pill that helps people who have trouble falling or staying asleep to sleep better. It helps you fall asleep faster and stay asleep for longer.

Dayvigo belongs to a class of drugs known as orexin antagonists. Dayvigo works by blocking orexin receptors (OX1R and OX2R), which prevents orexin A and B from binding to them. Orexin A and B are part of the orexin neuropeptide signaling system and one of their roles is to promote wakefulness. Blocking them from their receptor binding sites is thought to help suppress the urge to wake up. This class of drugs works differently from benzodiazepines which have been used to treat insomnia for many years.

Dayvigo is a schedule IV federally controlled substance (CIV) because it can be abused or cause dependence. Selling or giving away Dayvigo may harm others and is against the law.

Dayvigo was first approved by the US Food and Drug Administration in 2019.

Dayvigo is a prescription medicine used to treat adults who have trouble falling or staying asleep (insomnia).

It is not known if this medication is safe and effective in children under the age of 18 years.

• Take Dayvigo exactly as your healthcare provider tells you to take it.
• Only take one time each night, right before going to bed.
• Only take when you can stay in bed for a full night (at least 7 hours).
• Dayvigo may take longer to work if you take it with or soon after a meal.
• Do not increase your dose without talking to your healthcare provider first. Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Dayvigo may cause serious side effects including:

• Decreased awareness and alertness. The morning after you take this medication, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Do not take more than prescribed. Do not take unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. Take right before going to bed.

See “What are the possible side effects of Dayvigo?” below for more information about side effects.

Do not take Dayvigo if you fall asleep often at unexpected times (narcolepsy).

Before taking Dayvigo, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts.
• have a history of drug or alcohol abuse or addiction.
• have a history of a sudden onset of muscle weakness (cataplexy).
• have a history of daytime sleepiness.
• have lung problems or breathing problems, including sleep apnea.
• have liver problems.

Dayvigo may cause serious side effects, including:

• see “Important information" above
• temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up.
• temporary weakness in your legs that can happen during the day or at night.
• complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Call your healthcare provider right away if you experience a complex sleep behavior.
• worsening depression and suicidal thoughts have happened during treatment with this medication. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.

The most common side effect of Dayvigo is sleepiness.

These are not all of the possible side effects of this medication. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The recommended dose of Dayvigo is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to 10 mg per night if required.

In patients with moderate liver/hepatic impairment the maximum dose of Dayvigo is 5 mg. This medication is not recommended in patients with severe hepatic impairment.

See Full Prescribing Information for further details about Dayvigo dosing.

If you forget to take your dose of Dayvigo right before going to bed, skip that dose unless you can still stay in bed for at least 7 hours (a full nights sleep) after taking it. If you do not remember in time, wait until your next dose is due the following night. Do not take a double dose if you miss a dose.

If you take too much Dayvigo, call your healthcare provider or go to the nearest hospital emergency room right away.

• Do not drink alcohol while taking Dayvigo. It can increase your chances of getting serious side effects.
• Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you take Dayvigo and have had less than a full night of sleep (at least 7 hours) or if you have taken more than prescribed by your healthcare provider.
• You may still feel drowsy the next day after taking this medication. Do not drive or do other dangerous activities until you feel fully awake.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Taking Dayvigo with certain other medicines can cause serious side effects. Dayvigo may affect the way other medicines work and other medicines may affect the way this medication works.

Do not take with other medicines that can make you sleepy unless your healthcare provider tells you to.

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

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Dayvigo can harm your unborn baby.

There is a pregnancy registry for women who are exposed to Dayvigo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-888-274-2378. Talk with your healthcare provider about the risk to your unborn baby if you take this medication during pregnancy.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Dayvigo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

• Store Dayvigo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep out of the reach of children.

Active ingredient: lemborexant

Inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. The tablet film coating contains: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either ferric oxide yellow for the 5 mg tablet; or both ferric oxide yellow and ferric oxide red for the 10 mg tablet.

Dayvigo is distributed by Eisai Inc. Nutley, NJ 07110.