Dayvigo 5mg Tablets
It is used to treat sleep problems.
Drug Class
Hypnotic
Pharmacologic Class
Dual Orexin Receptor Antagonist (DORA)
Pregnancy Category
Not available
FDA Approved
Dec 2019
DEA Schedule
Schedule IV
Overview
What is this medicine?
Dayvigo (lemborexant) is a medication used to treat insomnia, which is trouble falling or staying asleep. It works by blocking certain brain chemicals that promote wakefulness, helping you fall asleep and stay asleep.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Take this medication immediately before bedtime, with or without food. However, if you take it with or shortly after a meal, it may take longer to start working. If you continue to have trouble sleeping after 7 to 10 days, contact your doctor for further guidance.
It's essential to take this medication only when you can get a full night's sleep, which means at least 7 to 8 hours of uninterrupted sleep before you need to be active again.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if taking the missed dose would interfere with getting at least 7 hours of sleep before you need to be active again, skip the missed dose and resume your regular dosing schedule. Do not take more than one dose of this medication in a 24-hour period.
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Take this medication immediately before bedtime, with or without food. However, if you take it with or shortly after a meal, it may take longer to start working. If you continue to have trouble sleeping after 7 to 10 days, contact your doctor for further guidance.
It's essential to take this medication only when you can get a full night's sleep, which means at least 7 to 8 hours of uninterrupted sleep before you need to be active again.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if taking the missed dose would interfere with getting at least 7 hours of sleep before you need to be active again, skip the missed dose and resume your regular dosing schedule. Do not take more than one dose of this medication in a 24-hour period.
Lifestyle & Tips
- Take Dayvigo immediately before going to bed, only when you can get at least 7 hours of sleep.
- Do not take Dayvigo with food or right after a meal, as this can delay its effects.
- Avoid alcohol and other medications that can make you drowsy while taking Dayvigo.
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed, regular exercise).
- Do not drive or operate machinery the day after taking Dayvigo until you know how it affects you, as it can cause next-day drowsiness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg or 10 mg orally once per night, taken immediately before going to bed, with at least 7 hours remaining before planned awakening.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
initial_dose:
5 mg
max_dose:
10 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
Not studied in patients with end-stage renal disease requiring dialysis; use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A).
Moderate:
Maximum recommended dose is 5 mg once nightly (Child-Pugh B).
Severe:
Not recommended (Child-Pugh C).
Pharmacology
Mechanism of Action
Lemborexant is a dual orexin receptor antagonist (DORA) that blocks the binding of the wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R. By blocking the activity of orexin, which is involved in maintaining wakefulness, lemborexant suppresses wakefulness and promotes sleep.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50%
Tmax:
1-3 hours
FoodEffect:
High-fat meal delays Tmax by approximately 2 hours and decreases Cmax by 23%.
Distribution:
Vd:
Approximately 1950 L
ProteinBinding:
>90%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 17-19 hours
Clearance:
Not available
ExcretionRoute:
Feces (60-65%), Urine (25-30%)
Unchanged:
<1% (urine)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for sleep onset)
PeakEffect:
1-3 hours (correlates with Tmax)
DurationOfAction:
Effects persist throughout the night, supporting once-nightly dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Episodes of being unable to move or speak for up to several minutes while falling asleep or waking up
Muscle weakness, which can occur at any time of day or night and last from seconds to a few minutes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical attention if you experience:
Daytime sleepiness
Fatigue or weakness
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Episodes of being unable to move or speak for up to several minutes while falling asleep or waking up
Muscle weakness, which can occur at any time of day or night and last from seconds to a few minutes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical attention if you experience:
Daytime sleepiness
Fatigue or weakness
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual sleep behaviors (e.g., sleep-driving, sleep-walking, preparing and eating food, making phone calls, or having sex while not fully awake). These can be dangerous and you may not remember them.
- Worsening depression or new thoughts of harming yourself.
- Severe daytime sleepiness or dizziness.
- Allergic reactions (e.g., rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as narcolepsy (falling asleep unexpectedly) or liver problems.
If you are taking any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about a specific product, consult your doctor or pharmacist.
Any medications, including prescription and OTC drugs, natural products, or vitamins, that you are currently taking. This is crucial because some medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication.
* Note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always consult your doctor before starting, stopping, or changing the dose of any medication. Verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as narcolepsy (falling asleep unexpectedly) or liver problems.
If you are taking any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about a specific product, consult your doctor or pharmacist.
Any medications, including prescription and OTC drugs, natural products, or vitamins, that you are currently taking. This is crucial because some medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication.
* Note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always consult your doctor before starting, stopping, or changing the dose of any medication. Verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
After taking this drug, avoid operating a vehicle or engaging in any activities that require alertness, as it may cause drowsiness. You may still experience sleepiness the day after taking this medication, so refrain from these activities until you feel fully awake and alert.
Long-term use of sleep medications, such as taking them nightly for more than a few weeks, can lead to decreased effectiveness in addressing sleep problems, a phenomenon known as tolerance. Therefore, it is recommended to use sleep medications for a short duration only. If your sleep problems persist, consult your doctor for further guidance.
While taking this medication, avoid consuming alcohol, as it can exacerbate the sedative effects. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions.
Some individuals may experience complex sleep-related behaviors, such as driving, preparing and eating food, or engaging in sexual activity, while not being fully awake. Often, people do not recall these events. If you experience such episodes, inform your doctor promptly.
Grapefruit and grapefruit juice should be avoided while taking this medication, as they may interact with the drug.
This medication can cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns or questions, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
After taking this drug, avoid operating a vehicle or engaging in any activities that require alertness, as it may cause drowsiness. You may still experience sleepiness the day after taking this medication, so refrain from these activities until you feel fully awake and alert.
Long-term use of sleep medications, such as taking them nightly for more than a few weeks, can lead to decreased effectiveness in addressing sleep problems, a phenomenon known as tolerance. Therefore, it is recommended to use sleep medications for a short duration only. If your sleep problems persist, consult your doctor for further guidance.
While taking this medication, avoid consuming alcohol, as it can exacerbate the sedative effects. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions.
Some individuals may experience complex sleep-related behaviors, such as driving, preparing and eating food, or engaging in sexual activity, while not being fully awake. Often, people do not recall these events. If you experience such episodes, inform your doctor promptly.
Grapefruit and grapefruit juice should be avoided while taking this medication, as they may interact with the drug.
This medication can cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns or questions, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence (drowsiness)
- Sedation
- Confusion
- Dizziness
- Ataxia (loss of coordination)
- Respiratory depression (rare, but possible with co-ingestion of other CNS depressants)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, including monitoring vital signs and general symptomatic and supportive measures. Gastric lavage or activated charcoal may be considered if appropriate.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, indinavir, saquinavir, lopinavir/ritonavir, telithromycin, conivaptan)
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - significantly reduce lemborexant exposure and efficacy.
- Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, fluconazole, grapefruit juice) - require lemborexant dose reduction to 5 mg.
Monitoring
Baseline Monitoring
Sleep history and assessment for insomnia
Rationale: To confirm diagnosis and establish baseline sleep patterns.
Timing: Prior to initiation of therapy
Assessment for underlying sleep disorders (e.g., sleep apnea, restless legs syndrome)
Rationale: Insomnia may be a symptom of another disorder requiring specific treatment.
Timing: Prior to initiation of therapy
Mental status and psychiatric history (especially depression/suicidal ideation)
Rationale: Insomnia may be a symptom of depression, and worsening depression/suicidal ideation has been reported with hypnotics.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (sleep onset, sleep maintenance, total sleep time)
Frequency: Periodically, based on clinical judgment
Target: Improved sleep parameters
Action Threshold: Lack of efficacy may warrant dose adjustment or re-evaluation of diagnosis.
Adverse effects (e.g., daytime somnolence, dizziness, headache, abnormal sleep behaviors)
Frequency: Regularly, especially during initial treatment and dose changes
Target: Absence or minimal adverse effects
Action Threshold: Significant or bothersome adverse effects may require dose reduction or discontinuation.
Signs of worsening depression or suicidal ideation
Frequency: Regularly, especially in patients with pre-existing psychiatric conditions
Target: Stable mood/absence of suicidal ideation
Action Threshold: Any signs warrant immediate clinical evaluation and intervention.
Symptom Monitoring
- Daytime sleepiness or somnolence
- Dizziness
- Headache
- Nausea
- Abnormal sleep behaviors (e.g., sleep-driving, sleep-walking, sleep-eating, making phone calls while not fully awake)
- Worsening depression or emergence of suicidal thoughts/behaviors
- Anxiety
- Nightmares/abnormal dreams
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of lemborexant in pregnant women. Based on animal data, lemborexant may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed developmental toxicity (e.g., reduced fetal body weights, skeletal variations) at exposures higher than clinical doses.
Second Trimester:
Similar risks as first trimester based on animal data.
Third Trimester:
Similar risks as first trimester based on animal data; potential for CNS depression in neonate if used late in pregnancy.
Lactation
Lemborexant is present in the milk of lactating rats. It is unknown whether lemborexant is present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Dayvigo and any potential adverse effects on the breastfed infant from Dayvigo or from the underlying maternal condition.
Infant Risk:
Moderate risk (L3). Potential for sedation or other CNS effects in the infant. Monitor breastfed infants for somnolence and feeding difficulties.
Pediatric Use
Safety and effectiveness of Dayvigo have not been established in pediatric patients. Not recommended for use in patients under 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger adult patients. However, elderly patients may be more sensitive to the effects of lemborexant, particularly next-day somnolence and dizziness, which can increase the risk of falls. The recommended starting dose is 5 mg in elderly patients.
Clinical Information
Clinical Pearls
- Lemborexant is a Schedule IV controlled substance due to its potential for abuse and dependence, though the risk is considered low.
- Patients should be advised to take Dayvigo only when they are able to get a full night's sleep (at least 7 hours) to minimize the risk of next-day impairment.
- Complex sleep behaviors (e.g., sleep-driving, sleep-walking, sleep-eating) can occur with Dayvigo. Patients should be warned about these potential events, which can result in serious injury, and to discontinue the drug if they occur.
- Dayvigo is not recommended for patients with narcolepsy.
- Rebound insomnia or withdrawal symptoms are generally not observed upon discontinuation, but gradual tapering may be considered after prolonged use.
Alternative Therapies
- Other orexin receptor antagonists (e.g., suvorexant, daridorexant)
- Non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone, zaleplon)
- Melatonin receptor agonists (e.g., ramelteon)
- Antidepressants with sedating properties (e.g., trazodone, doxepin)
- Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacological treatment.
Cost & Coverage
Average Cost:
Varies, typically $350-$500 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.