Dayvigo (Lemborexant) - Oral

What Is Dayvigo?

Dayvigo (lemborexant) is a prescription medication to treat trouble sleeping (insomnia). It may help you fall asleep sooner and stay asleep longer.

Dayvigo is an orexin receptor inhibitor. It attaches to binding sites called orexin receptors. Orexin A and orexin B are brain chemicals that encourage you to stay awake. This medication prevents orexin A and orexin B from binding to their receptors. Dayvigo helps you sleep by blocking these proteins that might keep you awake.

Dayvigo is available in a prescription tablet that you take by mouth (oral).

What Is Dayvigo Used For?

Dayvigo is used for insomnia. It may help you fall asleep faster and stay asleep longer.

Adults generally need at least seven hours of sleep every night. However, one in three adults in the United States gets less than the recommended amount of sleep. Not sleeping enough is linked to several medical conditions, including depression, type 2 diabetes, heart disease, and obesity.

How to Take Dayvigo

Take Dayvigo once nightly, right before bedtime. Before taking Dayvigo, make sure that you have at least seven hours before you need to wake up the next day. Do not take Dayvigo with a meal or right after a meal.

Storage

Keep this medication at room temperature between 68 degrees to 77 degrees Fahrenheit. It has a short-term safety storage range between 59 degrees to 86 degrees Fahrenheit.

Keep your medications tightly closed and out of reach of children and pets. Ideally, you should keep your medication locked in a cabinet or closet.

Do not pour unused and expired drugs down the drain or toilet. Visit the FDA's website to find out where and how to discard of unused and expired medications. You can also find disposal boxes in your area. Ask your pharmacist or healthcare provider if you have any questions about the best ways to dispose of your medications.

If you plan to travel with Dayvigo, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate can be a helpful resource. Before you go, make a copy of your Dayvigo prescription.

Keep your medication in its original container from your pharmacy with your name on the label. Since Dayvigo is a controlled substance, ask your provider for a document of medical necessity on a letter with an official letterhead. Ask your pharmacist or provider if you have any questions about traveling with your medicine.

Off-Label Uses

Dayvigo currently does not have any off-label uses.

What are the Side Effects of Dayvigo?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects while taking Dayvigo, contact your pharmacist or healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects of Dayvigo include:

• Drowsiness or sleepiness
• Headache
• Nightmares or abnormal dreams
• Tiredness or low energy
  

Severe Side Effects

Get medical help right away if you develop the following severe side effects. Call 911 if your symptoms feel life-threatening.

Potentially serious side effects of Dayvigo include:

• Severe allergic reaction with symptoms of itchiness, swelling, and breathing difficulties
• Complex sleep behaviors such as sleepwalking or sleep-driving
• Decreased lung function
• Hallucinations while in a state between dreaming and being awake
• Sleep paralysis
• Sudden muscle weakness while awake
• Suicidal thoughts
• Trouble staying alert
• Unsteady muscle movements
• Worsening depression

Long-Term Side Effects

If your insomnia has not improved within seven to 10 days after starting Dayvigo, tell your healthcare provider. Another medical condition might be causing your sleeping problems.

In a clinical trial on Dayvigo's effectiveness, the medication was used for up to 12 months. The people in the study only reported mild to moderate side effects. The most common side effects were:

• Common cold-like symptoms
• Drowsiness or sleepiness
• Headache

After stopping Dayvigo, the people in the study did not experience worsening (rebound) insomnia or withdrawal side effects.

Dosage: How Much Dayvigo Should I Take?

Modifications

The following changes (modifications) should be kept in mind when using Dayvigo (lemborexant):

Severe allergic reaction: Avoid using Dayvigo if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In rat and rabbit studies, very high amounts of lemborexant were found to have negative effects on a fetus. However, we don't know enough about the safety and effectiveness of Dayvigo in pregnant people and fetuses. If you plan to become pregnant or are pregnant, talk to your provider about taking Dayvigo. They will help you weigh the benefits and risks of using this medication during your pregnancy. They can also help you enroll in the Dayvigo pregnancy exposure registry by calling 1-888-274-2378.

Breastfeeding: In rat studies, lemborexant was present in breast milk. Dayvigo could possibly be present in human breast milk. Since Dayvigo binds to proteins in the bloodstream, only small amounts of medication will likely cross over into breast milk and reach a nursing infant.

There's usually no reason to stop Dayvigo if the breastfeeding parent needs the medication. The nursing infant, however, should be closely monitored for side effects, such as excessive drowsiness or sleepiness.

Talk with your healthcare provider if you plan to breastfeed while you are taking Dayvigo. They will help you weigh the benefits and harms of using Dayvigo while nursing. They can also discuss the different options you have for feeding your baby while you're using this medication.

Older adults over 65: Research has shown no differences in Dayvigo's effectiveness between older and younger adults. Older and younger adults experienced similar side effects of Dayvigo when taking 5 milligrams (mg) nightly (including drowsiness and sleepiness). However, when taking 10 milligrams (mg) nightly, older adults had more side effects than younger adults. Caution should be used in older adults taking Dayvigo at doses above 5mg.

Children: There is little information on the effectiveness and safety of Dayvigo in children.

Kidney problems: You do not need to adjust your dose if you have kidney impairment. However, use caution because you may experience more side effects like drowsiness or sleepiness from this medication.

Liver problems: If you have mild liver impairment, you might experience more drowsiness or sleepiness side effects with Dayvigo. Your healthcare provider may adjust your dose if you have moderate liver impairment. Dayvigo is not recommended if you have severe liver impairment.

Breathing or lung problems: Dayvigo did not worsen symptoms in people with mild obstructive sleep apnea (OSA). However, the medication has not been studied in people with moderate to severe OSA or lung conditions, such as chronic obstructive pulmonary disease (COPD).

Missed Dose

If you miss a dose, take it as soon as you remember as long as you have at least seven hours to devote to sleep. If you do not have at least seven hours before you need to wake up, do not take Dayvigo. Missed doses of Dayvigo are not typically linked to worsening insomnia (rebound) or withdrawal side effects.

Overdose: What Happens If I Take Too Much Dayvigo?

There is limited information on Dayvigo overdoses. A likely effect of taking too much Dayvigo would be excessive drowsiness and sleepiness.

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Dayvigo?

Before taking Dayvigo (lemborexant), talk with your healthcare provider if any of the following applies to you:

• Severe allergic reaction: If you have a severe allergic reaction to Dayvigo or its ingredients, you should not take it.
• Narcolepsy: Dayvigo should be avoided in people with narcolepsy. Some of Dayvigo's serious side effects are similar to the symptoms of narcolepsy, including sleep paralysis and sudden muscle weakness while awake (cataplexy). Dayvigo may cause daytime sleepiness, which is another symptom of narcolepsy.
• Pregnancy: We do not know enough about the safety and effectiveness of Dayvigo in pregnant people and their unborn fetuses. Weigh the benefits and risks of using Dayvigo during pregnancy with your provider. They can also help you enroll in the Dayvigo pregnancy exposure registry by calling 1-888-274-2378.
• Breastfeeding: Only small amounts of medication are likely to cross into breast milk and reach a nursing baby. There is usually no reason to stop Dayvigo if the breastfeeding parent needs the medication. The nursing infant should be closely monitored for side effects, such as excessive drowsiness or sleepiness. Talk with your healthcare provider about the benefits and possible harms of using Dayvigo while nursing.
• Older adults over 65: There were no differences in Dayvigo's effectiveness between older and younger adults. However, at nightly doses above 5mg, older adults tended to have more side effects than younger adults.
• Children: There is little information about the effectiveness and safety of Dayvigo in children.
• Kidney problems: There's no need to adjust your Dayvigo dose if you have kidney impairment, but use caution because you might have more drowsiness or sleepiness.
• Liver problems: If you have mild liver impairment, you might have more drowsiness or sleepiness from taking Dayvigo. Your provider will likely adjust your dose if you have moderate liver impairment. Dayvigo is not recommended if you have severe liver impairment.
  

What Other Medications Interact With Dayvigo?

Use caution when taking Dayvigo with the following medications:

CYP3A4-inhibiting medications: CYP3A4 is a liver protein responsible for breaking down and clearing out drugs like Dayvigo. CYP3A4-inhibiting medications prevent CYP3A4 from working as well. This may lead to higher levels of Dayvigo in the body and a higher likelihood of side effects.

Avoid combining Dayvigo with strong or moderate inhibitors of CYP3A4. Dayvigo's dose will need to be reduced with weak inhibitors of CYP3A4.

Examples of strong CYP3A4-inhibiting medications include clarithromycin (an antibiotic) and itraconazole (an antifungal). Examples of moderate CYP3A4-inhibiting medications include fluconazole (an antifungal) and verapamil (a heart medication). The blood thinner Brilinta (ticagrelor) blood thinner is an example of a weak CYP3A4 inhibitor.

CYP3A4-inducing medications: CYP3A4-inducing medications encourage CYP3A4 to break down Dayvigo quickly. This may lead to low Dayvigo levels in the body, resulting in decreased effectiveness. Avoid taking Dayvigo with strong or moderate CYP3A4-inducing medications.

Examples of strong CYP3A4-inducing medications include rifampin for tuberculosis (TB), carbamazepine for seizures, and St. John's wort for depression. Examples of moderate CYP3A4-inducing medications include some human immunodeficiency virus (HIV) medications, such as efavirenz.

CYP2B6 substrates: CYP2B6 is another liver protein that breaks down medications, such as bupropion for depression and methadone for pain. Medicines that are broken down by CYP2B6 are called CYP2B6 substrates.

Dayvigo encourages CYP2B6 to quickly break down CYP2B6 substrates, leading to low levels in the body and making the substrates less effective. For this reason, your healthcare provider may monitor you to ensure that CYP2B6 substrates work for you. If necessary, they may increase the doses of your CYP2B6-substrate medications.

Talk with your pharmacist or provider for more detailed information about medication interactions with Dayvigo.

Tell your provider about any other medicines you take or plan to take, including over-the-counter (OTC) nonprescription products, vitamins, herbs, supplements, and plant-based medicines.

What Medications Are Similar?

In addition to Dayvigo, other sleep medications may include:

• Ambien (zolpidem)
• Belsomra (suvorexant)
• Hetlioz (tasimelteon)
• Lunesta (eszopiclone)
• Rozerem (ramelteon)
• Silenor (doxepin)
• Sonata (zaleplon)
• Melatonin

Since these medications are used to treat insomnia, they are not usually taken together. If you have any questions, discuss them with your healthcare provider. 

The choice of sleep medication is dependent on the following factors:

• Do you have trouble falling asleep?
• Do you have trouble staying asleep?
• Do you have trouble falling and staying asleep?

If you have problems with falling asleep, staying asleep, or both, Dayvigo is a potential choice.

How Can I Stay Healthy While Taking Dayvigo?

Before you start taking Dayvigo, your provider will want to make sure you don't have a sleep disorder like sleep apnea. Your provider may want you to do a sleep study to rule this or other conditions out.

Experts recommend practicing good sleep hygiene to help with sleep. Although Dayvigo may help you fall asleep and stay asleep longer, there are also other strategies you can use to get a better night's sleep and avoid ruining your sleep:

• Have a scheduled time for going to bed and waking up
• Avoid eating large meals before bedtime
• Don't drink coffee or alcohol right before you go to bed
• Avoid intense exercise right before bedtime but get enough exercise during the day
• Avoid smoking or using tobacco products and quit if you do
• Use your bed only for sleep
• Do not read or watch TV in bed
• Make sure your bedroom is a comfortable environment that is not too cold, too warm, or too loud
• Try sleep stories or apps to relax before bed