Dayvigo 10mg 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
Not Controlled
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 chemicals in your brain that help keep you awake, allowing you to fall asleep more easily and stay asleep longer.
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 experience difficulty sleeping after 7 to 10 days, contact your doctor for further guidance.
It's essential to take this medication only when you can devote a full night's sleep to it, meaning you should have at least 7 to 8 hours available 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 secure place, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs 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 your ability to get a full night's sleep (at least 7 hours), 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 experience difficulty sleeping after 7 to 10 days, contact your doctor for further guidance.
It's essential to take this medication only when you can devote a full night's sleep to it, meaning you should have at least 7 to 8 hours available 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 secure place, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs 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 your ability to get a full night's sleep (at least 7 hours), 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 getting into bed, with at least 7 hours remaining before your planned awakening.
- Do not take Dayvigo with or immediately after a heavy 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/nicotine before bed, limiting screen time).
- Do not drive or operate machinery until you know how Dayvigo affects you, as it can cause drowsiness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once nightly, taken no earlier than 30 minutes before going to bed, with at least 7 hours remaining before planned awakening. Dose may be increased to 10 mg if 5 mg is not effective.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
moderate_hepatic_impairment:
Maximum recommended dose is 5 mg once nightly.
concomitant_moderate_CYP3A_inhibitors:
Maximum recommended dose is 2.5 mg once nightly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not studied in patients with end-stage renal disease (ESRD) on dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Maximum recommended dose is 5 mg once nightly.
Severe:
Not recommended.
Pharmacology
Mechanism of Action
Lemborexant is a dual orexin receptor antagonist (DORA) that binds to orexin receptor 1 (OX1R) and orexin receptor 2 (OX2R). By blocking the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors, lemborexant suppresses wake drive, thereby promoting sleep.
Pharmacokinetics
Absorption:
Bioavailability:
~80%
Tmax:
1-3 hours
FoodEffect:
A high-fat meal delays Tmax by approximately 2 hours and decreases Cmax by 23%. No significant effect on AUC.
Distribution:
Vd:
1950 L
ProteinBinding:
>98%
CnssPenetration:
Yes
Elimination:
HalfLife:
17-19 hours (for 10 mg dose)
Clearance:
6.7 L/hr
ExcretionRoute:
Feces (62%), Urine (30%)
Unchanged:
<1% (urine), 11% (feces)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for sleep onset)
PeakEffect:
Not explicitly defined for therapeutic effect, but Tmax is 1-3 hours.
DurationOfAction:
Provides sleep maintenance throughout the night (approximately 7-8 hours).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 last from seconds to a few minutes and may occur at night or during the day. If this happens, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Feeling sleepy the next day
Feeling tired or weak
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 last from seconds to a few minutes and may occur at night or during the day. If this happens, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Feeling sleepy the next day
Feeling tired or weak
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Excessive daytime sleepiness or dizziness
- Unusual or complex sleep behaviors (e.g., sleep-walking, sleep-driving, making phone calls, or eating while not fully awake). If these occur, stop taking Dayvigo and contact your doctor immediately.
- Worsening of depression or new thoughts of self-harm or suicide
- Hallucinations or unusual thoughts
- Anxiety or agitation
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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Narcolepsy (falling asleep unexpectedly)
+ Liver problems
Use of any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about specific products, consult your doctor or pharmacist.
Concurrent use of other medications, including prescription or OTC drugs, natural products, or vitamins, that may interact with this medication. This is particularly important for certain medications used to treat:
+ HIV
+ Infections
+ Seizures
+ Other conditions
Please note that this is not an exhaustive list of interacting medications or health problems.
To ensure safe use, it is crucial to discuss all of your:
Medications (prescription or OTC)
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Narcolepsy (falling asleep unexpectedly)
+ Liver problems
Use of any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about specific products, consult your doctor or pharmacist.
Concurrent use of other medications, including prescription or OTC drugs, natural products, or vitamins, that may interact with this medication. This is particularly important for certain medications used to treat:
+ HIV
+ Infections
+ Seizures
+ Other conditions
Please note that this is not an exhaustive list of interacting medications or health problems.
To ensure safe use, it is crucial to discuss all of your:
Medications (prescription or OTC)
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all 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 such tasks until you feel fully awake and alert.
Long-term use of sleep medications, including this drug, for more than a few weeks can lead to tolerance, reducing their effectiveness in addressing sleep problems. 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 drug's effects. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your actions.
Some individuals may experience complex sleep-related behaviors, such as driving, cooking, eating, or engaging in sexual activities, while not being fully awake. These events typically occur without recall. If you experience any such incidents, 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 impaired 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.
It is crucial to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for 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 such tasks until you feel fully awake and alert.
Long-term use of sleep medications, including this drug, for more than a few weeks can lead to tolerance, reducing their effectiveness in addressing sleep problems. 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 drug's effects. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your actions.
Some individuals may experience complex sleep-related behaviors, such as driving, cooking, eating, or engaging in sexual activities, while not being fully awake. These events typically occur without recall. If you experience any such incidents, 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 impaired 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.
It is crucial to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive sedation
- Drowsiness
- Confusion
- Dizziness
- Impaired coordination
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive, including monitoring vital signs and general supportive measures.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat, indinavir, lopinavir, nelfinavir, saquinavir, telithromycin, conivaptan)
Major Interactions
- Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, fluconazole, grapefruit juice) - reduce lemborexant dose to 2.5 mg
- Alcohol - additive CNS depressant effects
- Other CNS depressants (e.g., opioids, benzodiazepines, tricyclic antidepressants, sedating antihistamines, antipsychotics, muscle relaxants) - additive CNS depressant effects
Moderate Interactions
- Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may significantly decrease lemborexant exposure and efficacy
- Moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) - may decrease lemborexant exposure and efficacy
Monitoring
Baseline Monitoring
Comprehensive sleep history and physical examination
Rationale: To identify underlying causes of insomnia and rule out other sleep disorders (e.g., sleep apnea, narcolepsy) or psychiatric comorbidities.
Timing: Prior to initiation of therapy
Assessment for depression and suicidal ideation
Rationale: Insomnia may be a symptom of underlying psychiatric disorders, and treatment with hypnotics may worsen depression or suicidal thoughts.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy of sleep onset and maintenance
Frequency: Periodically, based on patient response
Target: Improved sleep latency, reduced wakefulness after sleep onset, increased total sleep time
Action Threshold: Lack of improvement or worsening of insomnia symptoms may require dose adjustment or re-evaluation of diagnosis.
Daytime somnolence/sedation
Frequency: Regularly, especially during initial treatment and dose adjustments
Target: Minimal to no daytime impairment
Action Threshold: Significant daytime sleepiness, impaired driving, or other activities requiring full alertness may necessitate dose reduction or discontinuation.
Occurrence of complex sleep behaviors (e.g., sleep-walking, sleep-driving, preparing/eating food, making phone calls, engaging in sexual activity)
Frequency: Regularly, inquire with patient and family/caregivers
Target: Absence of such behaviors
Action Threshold: Any occurrence requires immediate discontinuation of the drug.
Worsening of depression or emergence of suicidal thoughts/behaviors
Frequency: Regularly, inquire with patient and family/caregivers
Target: Stable mood, absence of suicidal ideation
Action Threshold: Any worsening or new onset requires immediate medical attention and re-evaluation of treatment.
Symptom Monitoring
- Daytime somnolence
- Dizziness
- Fatigue
- Headache
- Nausea
- Abnormal dreams
- Hallucinations
- Anxiety
- Worsening depression
- Suicidal thoughts or behaviors
- Complex sleep behaviors (e.g., sleep-walking, sleep-driving, preparing/eating food, making phone calls, engaging in sexual activity while not fully awake)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of lemborexant in pregnant women. Animal studies have shown adverse developmental effects at doses higher than clinical exposure. Dayvigo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk of adverse developmental effects observed in animal studies at high doses.
Second Trimester:
Risk of adverse developmental effects observed in animal studies at high doses.
Third Trimester:
Risk of adverse developmental effects observed in animal studies at high doses.
Lactation
It is not known whether lemborexant is excreted in human milk. Lemborexant and its metabolites were detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered 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:
Potential for sedation or other adverse effects in breastfed infant. Monitor for drowsiness or feeding difficulties.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Dayvigo is not recommended for use in this population.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (65 years and over) and younger subjects. However, elderly patients may be more sensitive to the effects of Dayvigo, particularly the risk of falls due to somnolence. The recommended starting dose is 5 mg once nightly for all adults, including the elderly.
Clinical Information
Clinical Pearls
- Instruct patients to take Dayvigo immediately before getting into bed, not just before planning to go to bed, and to ensure they have at least 7 hours available for sleep.
- Advise patients that taking Dayvigo with or immediately after a heavy meal may delay its onset of action.
- Emphasize the importance of avoiding alcohol and other CNS depressants due to additive effects.
- Educate patients and their families about the potential for complex sleep behaviors (e.g., sleep-walking, sleep-driving) and to discontinue the drug immediately if these occur.
- Prior to initiating treatment, thoroughly assess patients for underlying sleep disorders (e.g., sleep apnea, narcolepsy) or psychiatric conditions that may contribute to insomnia.
- Dayvigo is not recommended for patients with narcolepsy.
Alternative Therapies
- Suvorexant (Belsomra) - another DORA
- Daridorexant (Quviviq) - another DORA
- Zolpidem (Ambien) - GABA-A receptor agonist
- Eszopiclone (Lunesta) - GABA-A receptor agonist
- Zaleplon (Sonata) - GABA-A receptor agonist
- Ramelteon (Rozerem) - Melatonin receptor agonist
- Doxepin (Silenor) - Histamine H1 receptor antagonist (low dose)
- Trazodone - Antidepressant with sedative properties
- Cognitive Behavioral Therapy for Insomnia (CBT-I) - non-pharmacological treatment
Cost & Coverage
Average Cost:
Varies, typically $350-$500+ per 30 tablets
Insurance Coverage:
Tier 3 or higher, often requires prior authorization
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.