Dayvigo (lemborexant) for Treating Adult Insomnia

Dayvigo is an oral medication containing the active ingredient lemborexant. It is prescribed to adults who have insomnia characterized by difficulty falling asleep or staying asleep. Dayvigo works by blocking orexin receptors in the brain, which helps reduce wakefulness and promote sleep.

Dayvigo is approved for the treatment of insomnia in adults, specifically for those experiencing trouble with sleep onset and/or sleep maintenance.

lemborexant

Dayvigo contains lemborexant, which acts as a competitive antagonist of orexin receptors OX1R and OX2R in the brain. Orexin neuropeptides normally promote wakefulness by binding these receptors. By blocking these receptors, Dayvigo suppresses the wake drive, thus facilitating sleep initiation and maintenance.

The recommended starting dose is 5 mg taken once nightly, orally, immediately before bedtime, with at least 7 hours remaining before planned awakening. Based on clinical response and tolerability, the dose may be increased to a maximum of 10 mg once daily.

Taking Dayvigo with or soon after a meal may delay sleep onset.

For patients with moderate hepatic impairment, the dose should not exceed 5 mg once nightly. Dayvigo is not recommended in patients with severe hepatic impairment.

Drug interaction considerations:

• Avoid concomitant use with strong or moderate CYP3A inhibitors and inducers.
• When co-administered with weak CYP3A inhibitors, limit dose to a maximum of 5 mg once daily.

Dayvigo is contraindicated in patients with narcolepsy.

CNS Depressant Effects: Dayvigo can impair alertness and motor coordination during the day. The risk of impairment increases with higher dose and when combined with other CNS depressants. Patients taking 10 mg should avoid next-day driving or activities requiring full alertness.

Complex Sleep Behaviors: Sleepwalking, sleep-driving, or engaging in other activities while not fully awake can occur. If these events happen, discontinue Dayvigo immediately.

Sleep Paralysis and Hallucinations: Patients may experience transient episodes of inability to move or speak during sleep-wake transitions and vivid hallucinations.

Respiratory Function: Use cautiously in patients with compromised respiratory function such as moderate to severe chronic obstructive pulmonary disease (COPD) or obstructive sleep apnea (OSA).

Worsening Depression and Suicidal Ideation: Monitor patients for new or worsening depression or suicidal thoughts. Prescribe the lowest feasible number of tablets to reduce risk of intentional overdose.

Co-morbid Diagnoses: If insomnia does not improve after 7 to 10 days of treatment, reevaluate for underlying medical or psychiatric conditions.

Common adverse reactions (≥5% incidence with Dayvigo and at least twice placebo rate):

• Somnolence or fatigue (reported in up to 10% with 10 mg dose)
• Headache
• Nightmares or abnormal dreams

Other observed adverse reactions include:

• Sleep paralysis (1.3% to 1.6%)
• Hypnagogic hallucinations (up to 0.7%)
• Complex sleep behaviors (rare, reported only with 10 mg dose)

Adverse reactions leading to discontinuation: Most commonly somnolence and nightmares.

CYP3A Inhibitors:

• Avoid strong and moderate CYP3A inhibitors (e.g., itraconazole, clarithromycin, fluconazole, verapamil) with Dayvigo.
• When used with weak CYP3A inhibitors (e.g., chlorzoxazone, ranitidine), limit Dayvigo to 5 mg once daily.

CYP3A Inducers: Avoid concomitant use with strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort, bosentan, efavirenz, modafinil) due to reduced Dayvigo efficacy.

Alcohol: Avoid drinking alcohol with Dayvigo since it increases the risk of impaired postural stability and memory.

Effect of Dayvigo on other drugs: Dayvigo may decrease the exposure of CYP2B6 substrates (e.g., bupropion, methadone), potentially reducing their effectiveness; monitor clinical response.

Pregnancy: There are no adequate data on use in pregnant women. Animal studies showed toxic effects at exposures much higher than recommended human doses. Pregnant patients should be advised to enroll in the National Pregnancy Registry for Psychiatric Medications.

Lactation: Dayvigo is present in breastmilk at low levels. Monitor breastfed infants for excessive sedation. Consider benefits of breastfeeding along with the mother's clinical need for Dayvigo and potential risks to the infant.

Limited clinical experience with overdose. Doses up to 75 mg produced dose-related somnolence. No specific antidote exists. In overdose cases, provide supportive care with monitoring. Hemodialysis is unlikely to be effective due to high protein binding of lemborexant.

Store Dayvigo tablets at 20°C to 25°C (68°F to 77°F) with allowable excursions between 15°C and 30°C (59°F and 86°F).