Dayvigo (lemborexant)

Overview

What is DAYVIGO?

DAYVIGO contains the active ingredient lemborexant. It is an orexin receptor antagonist used for the treatment of insomnia in adults, specifically for difficulties with sleep onset and/or sleep maintenance.

The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Global Name

• Generic names: lemborexant
• Brand names: DAYVIGO®

Usage

What is DAYVIGO used for?

How do you use DAYVIGO? 

Dosage form: film-coated tablets, 5 mg and 10 mg

Tablet description: 5 mg tablet is pale yellow, round, biconvex; 10 mg tablet is orange, round, biconvex

Dosage information:

• Contraindicated in patients with narcolepsy.
• Use is not recommended in severe hepatic impairment.
• Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors or inducers such as carbamazepine, rifampin, efavirenz and St. John’s wort.

Warnings and Precautions: 

• DAYVIGO is a CNS depressant and may impair daytime wakefulness; risk is higher if taken without a full night of sleep remaining or at higher than recommended doses.
• Patients should avoid alcohol while taking DAYVIGO.
• Complex sleep behaviors, sleep paralysis, hallucinations, cataplexy-like symptoms, falls, and worsening of depression or suicidal ideation have been reported or warned in the PI.
• Safety and effectiveness have not been established in pediatric patients.
• Due to a lack of clinical data, the risks of using DAYVIGO during pregnancy and lactation are undetermined; therefore, any infant exposed through breastmilk must be closely monitored for excessive sedation.
• DAYVIGO has not been studied in patients with moderate to severe obstructive sleep apnea (OSA); however, in clinical studies of patients with mild OSA, DAYVIGO did not increase the frequency of apnea or hypopnea events.

Interactions and Contraindications of DAYVIGO:  

• Drug interactions: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors or inducers. 
• Contraindications: Use in patients with narcolepsy.

Side Effects

Common side effects may include:

• Somnolence
• Fatigue
• Headache
• Nightmares and abnormal dreams

Pharmacist Tips

• Storage information: Store under 30°C in the original blister in order to protect from moisture and keep out of the reach of children.

• Administration:

  • Take DAYVIGO only once each night, right before going to bed.

  • Only take it when you can remain in bed for at least 7 hours before needing to be active again due to increased risk of daytime somnolence.

  • Do not increase the dose on your own. If insomnia worsens or is not improved within 7 to 10 days, medical review is advised in the PI.

  • Avoid alcohol and avoid combining with other medicines that can make you sleepy (such as benzodiazepines & antihistamines) unless directed by a healthcare professional.

    • Avoid use if less than a full night of sleep can be achieved if driving and other activities requiring complete mental alertness.

  • Tell healthcare providers about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements because clinically relevant CYP3A and CYP2B6 interactions are described in the PI.

Availability

Where is DAYVIGO available in Hong Kong?

DAYVIGO is a prescription medicine for adults with insomnia.

FAQs

Can I drink alcohol while taking DAYVIGO?

No. Patients should not to consume alcohol in combination with DAYVIGO because of additive CNS depressant effects, and alcohol can increase the chance of serious side effects.

How should DAYVIGO be taken?

Take it only once each night, right before going to bed, and only when at least 7 hours remain before you need to be active again. It can be taken regardless of meals, but the time to sleep onset may be delayed if it is taken with or soon after a meal.

Is DAYVIGO safe in children?

Safety and effectiveness have not been established in pediatric patients under 18 years of age.

What should patients know about pregnancy or breastfeeding?

There are no available data in pregnant women to evaluate drug-associated risk, use in pregnancy therefore is always on the side of caution after consultation with a medical professional. DAYVIGO passes into breast milk at low levels in a lactation study, and breastfed infants should be monitored for excessive sedation.