Lemborexant (Dayvigo) - Eisai's Insomnia Drug

Lemborexant (Dayvigo) - Eisai's Insomnia Drug - has recently been approved for the treatment of insomnia. It is indicated in patients having difficulty falling asleep or maintaining sleep at night.


Lemborexant (Dayvigo) Dose in Adults

Lemborexant (Dayvigo) Dose in the treatment of Insomnia:

  • Take 5 milligrams by mouth once every day before bedtime, making sure you'll get at least seven hours of sleep before you need to wake up.

  • Your doctor might raise the dose if needed, but the highest dose shouldn't go over 10 milligrams per day.

Dosage adjustment for concomitant therapy:

  • If you're taking weak CYP3A inhibitors like chlorzoxazone or ranitidine, don't take more than 5 milligrams per day as the highest dose.


Lemborexant (Dayvigo) Dose in Childrens:

 

It's not suggested for kids to use this medication.


Pregnancy Risk Factor: Undetermined

  • This medication hasn't been tested on pregnant women yet.

  • In studies on animals, some bad outcomes for the babies were seen.

Use while breastfeeding

  • We're not sure if this drug can pass into breast milk.

  • The maker suggests keeping an eye on your baby for any signs of sleepiness and thinking carefully about whether the benefits of taking the medication outweigh the risks for both you and your baby.


Lemborexant (Dayvigo) Dosage in Renal disease:

  • Mild to moderate renal impairment

    • Changing the dose isn't a big deal.
  • Grave renal impairment

    • You don't have to change the dose.

    • But if you have serious kidney problems, you might feel sleepier because your body might have more of the medication in it.

Lemborexant (Dayvigo) dosage in liver disease:

  • Mild impairment

    • Changing the dose isn't crucial.
  • Moderate impairment

    • Don't take more than 5 milligrams in a day.
  • Severe impairment

    • Don't use it if your liver is severely damaged.
    • We haven't checked how it works in severe liver disease.

Side Effects of Lemborexant (Dayvigo):

  • Central nervous system:

    • Drowsiness
    • Fatigue
    • Headache
    • Abnormal dreams
    • Nightmares
    • Sleep paralysis

Uncommon side effects of Lemborexant (dayvigo):

  • Cardiovascular:

    • Palpitations
  • Central nervous system:

    • Cataplexy
    • Central nervous system depression

Contraindication to Lemborexant (Dayvigo) Include:

  • Narcolepsy.

Warnings and precautions

  • Depression in the CNS:

    • This medication can make you feel drowsy and less alert, which might affect your ability to do everyday tasks.

    • Before starting treatment, make sure to warn people who need to be mentally sharp for activities like driving or using heavy machinery.

    • Some people might still feel drowsy the next day or even for a few days afterward.

    • Only give this medication to people who can sleep for up to seven hours after taking it.

    • Don't mix it with alcohol or other medications that make your central nervous system less active.

    • Using these together can increase the risk of feeling sleepy during the day.

    • In some cases, your doctor might give you a higher dose or allow you to sleep for less than seven hours.

  • Falls

    • This medication can make you feel sleepy, especially if you're older.

    • That might increase the chances of you falling down.

  • Rapid eye movement (REM), sleep effects

    • Some people might have experiences like sleep paralysis, mild cataplexy (brief weakness in the legs), or hallucinations when falling asleep or waking up.
    • Cataplexy can happen suddenly, causing temporary weakness in the legs, often triggered by things like laughter or surprise, and it can occur both during the day and at night.
  • Activities that are sleep-related:

    • This medication has been associated with engaging in risky behaviors during sleep, like sleepwalking, driving, cooking, eating, or making phone calls.

    • Patients might not remember these events afterward.

    • These behaviors can happen even when taking the recommended doses, with or without using alcohol or other drugs that affect the central nervous system.

    • If you experience any of these symptoms, you should stop taking the medication.

  • Depression

    • If you have depression, be careful when taking this medication.

    • Your doctor should keep an eye on you for signs of depression or thoughts of harming yourself. Depressed people are more likely to accidentally take too much of the drug.

    • They should only take the smallest effective dose.

    • Doctors should only prescribe enough for what's needed, to make sure you're safe.

  • Use of drugs:

    • Patients who have a history of drug addiction should be careful when using this medication.
  • Hepatic impairment

    • This medication hasn't been studied in people with liver disease.
  • Respiratory disease

    • People with chronic respiratory conditions, like sleep apnea or COPD, should be careful when using this medication.

    • It could lead to respiratory failure in these patients.

Lemborexant: Drug Interaction

Risk Factor C (Monitor therapy)

Alizapride

May enhance the CNS depressant effect of CNS Depressants.

Brimonidine (Topical)

May enhance the CNS depressant effect of CNS Depressants.

Bromopride

May enhance the CNS depressant effect of CNS Depressants.

Cannabidiol

May enhance the CNS depressant effect of CNS Depressants.

Cannabis

May enhance the CNS depressant effect of CNS Depressants.

Chlorphenesin Carbamate

May enhance the adverse/toxic effect of CNS Depressants.

Clofazimine

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).

Deferasirox

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Dimethindene (Topical)

CNS depressants may have an enhanced CNS depressant impact.

Dronabinol

May enhance the CNS depressant effect of CNS Depressants.

Erdafitinib

May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).

Erdafitinib

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).

Ivosidenib

May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).

Kava Kava

May enhance the adverse/toxic effect of CNS Depressants.

Lofexidine

CNS depressants may have an enhanced CNS depressant impact.  Management: Separate drug interaction monographs go into further  detail about the medications indicated as exceptions to this book.

Magnesium Sulfate

CNS depressants may have an enhanced CNS depressant impact.

Melatonin

May intensify hypnotics' sedative effects (Nonbenzodiazepine).

MetyroSINE

CNS depressants may have an enhanced CNS depressant impact.

Minocycline (Systemic)

CNS depressants may have an enhanced CNS depressant impact.

Nabilone

CNS depressants may have an enhanced CNS depressant impact.

Piribedil

CNS depressants may have an enhanced CNS depressant impact.

Pramipexole

CNS depressants may have an enhanced CNS depressant impact.

ROPINIRole

CNS Depressants may enhance the sedative effect of ROPINIRole.

Rotigotine

CNS Depressants may enhance the sedative effect of Rotigotine.

Rufinamide

May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced.

Sarilumab

May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).

Selective Serotonin Reuptake Inhibitors

CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced.

Siltuximab

May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).

Simeprevir

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).

Tetrahydrocannabinol

May enhance the CNS depressant effect of CNS Depressants.

Tetrahydrocannabinol and Cannabidiol

May enhance the CNS depressant effect of CNS Depressants.

Tocilizumab

May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).

Risk Factor D (Consider therapy modification)

Blonanserin

CNS Depressants may enhance the CNS depressant effect of Blonanserin.

Buprenorphine

CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants.

Chlormethiazole

May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used.

CNS Depressants

Lemborexant may make CNS depressants more effective at lowering blood  pressure. Management: Due to the possibility of additive CNS depressant  effects  when lemborexant and concurrent CNS depressants are administered  concurrently, dosage modifications may be required. Effects of CNS  depressants must be closely monitored.

CYP3A4 Inhibitors (Weak)

Lemborexant serum concentration can rise. Management: When  used in  conjunction with weak CYP3A4 inhibitors,  a maximum daily dose  of 5  mg  of lemborexant is advised.

Droperidol

May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs.

Flunitrazepam

CNS Depressants may enhance the CNS depressant effect of Flunitrazepam.

HYDROcodone

The CNS depressive action of HYDROcodone may be enhanced by CNS  depressants.  Management: Whenever feasible, refrain from using  hydrocodone  and  benzodiazepines or other CNS depressants concurrently.  Only in the event that other treatment choices are insufficient should these  medications be combined. Limit the duration and dosage of each medicine  when used together.

Methotrimeprazine

The CNS depressing action of methotrimeprazine may be enhanced by CNS depressants. The CNS depressant action of CNS Depressants may be strengthened by methotrimeprazine. Management: Start concurrent methotrimeprazine therapy while reducing the adult dose of CNS depressants by 50%. Only once a clinically effective dose of methotrimeprazine has been established should additional CNS depressant dosage modifications be made.

OxyCODONE

CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

Perampanel

May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination.

Stiripentol

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring.

Suvorexant

CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended.

Tapentadol

May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

Zolpidem

CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol.

Risk Factor X (Avoid combination)

Alcohol (Ethyl)

May enhance the CNS depressant effect of Lemborexant. Alcohol (Ethyl) may increase the serum concentration of Lemborexant.

Azelastine (Nasal)

CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal).

Bromperidol

May enhance the CNS depressant effect of CNS Depressants.

Conivaptan

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).

CYP3A4 Inducers (Moderate)

Lemborexant's serum concentration can drop.

CYP3A4 Inducers (Strong)

Lemborexant's serum concentration can drop.

CYP3A4 Inhibitors (Moderate)

Lemborexant's serum concentration can drop.

CYP3A4 Inhibitors (Strong)

Lemborexant's serum concentration can drop.

Fusidic Acid (Systemic)

May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors).

Idelalisib

May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).

Orphenadrine

CNS Depressants may enhance the CNS depressant effect of Orphenadrine.

Oxomemazine

May enhance the CNS depressant effect of CNS Depressants.

Paraldehyde

CNS Depressants may enhance the CNS depressant effect of Paraldehyde.

Sodium Oxybate

Hypnotics (Nonbenzodiazepine) may intensify Sodium Oxybate's CNS depressive  effects.

Thalidomide

The CNS depressing effect of thalidomide may be enhanced by CNS depressants.

Monitor:

  • Make sure to check liver and kidney function before starting the medication and as needed based on the patient's condition.
  • Also, keep an eye out for signs of depression and thoughts of harming oneself.

How to administer Lemborexant (Dayvigo)?

  • Take it by mouth at bedtime, making sure you'll get at least seven hours of sleep before you need to wake up.
  • If you take it right after or with a meal, it might take longer to start working and for you to fall asleep.

Mechanism of action of Lemborexant (Dayvigo):

This medication works by stopping certain brain chemicals, orexin A and orexin B, from attaching to their receptors, which helps reduce the drive to stay awake.

Here are some details about how it works in your body:

  • It starts working in about 15 to 20 minutes after you take it.
  • If you eat a high-fat meal, it might take about 2 hours longer to start working.
  • About 94% of the drug is absorbed into your body.
  • It's mostly broken down in your body by enzymes called CYP3A4 and CYP3A5, forming the main active metabolite called M10.
  • It takes between 17 and 19 hours for half of the medication to leave your body.
  • The highest amount of the drug in your blood is reached about 1 to 3 hours after taking it.
  • Your body mainly gets rid of it through your poop (about 57%) and pee (about 29%).

Lemborexant Brand Name (International):

  • Dayvigo

Lemborexant Brand Names in Pakistan:

It is not available in Pakistan.