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Dayvigo: Sleeping Medication

• This presentation discussed Dayvigo (lemborexant) indications for use, U.S. Food and Drug Administration approval, major interactions, side effects, and contraindications.

Indications for Use

• Dayvigo (lemborexant) is an orexin receptor antagonist whose controlled substance schedule is pending (FDA, 2019).
• Dayvigo is indicated for the treatment of adults with trouble falling or staying asleep (insomnia) (U.S. Food and Drug Administration (FDA), 2020).
• It is found as an oral tablet (5 mg and 10 mg tablets). It is taken not more than once per night; it should be taken straightaway after going to bed (FDA, 2019; 2020).
• Insomnia patients who take the drug tend to fall asleep faster and stay asleep longer compared to patients who receive placebo (FDA, 2020).
• The drug is being investigated for management of irregular sleep-wake rhythm disorder associated with mild to moderate Alzheimer’s disease (Scott, 2020).

FDA Approval

• Dayvigo received its first approval in December 2019 in the United States (Scott, 2020).
• FDA approved Dayvigo for management of insomnia based on primary evidence derived from two clinical trials (Trial 2/NCT02783729 and Trial 1/NCT02952820), which involved a total of 1,692 patients (FDA, 2020).
• The trials were conducted in 164 sites in Canada, United States, Europe, Japan, Mexico, Taiwan, and Korea (FDA, 2020).
• Mechanism of action is by blocking the binding of neuropeptides orexin B and orexin A to OX2R and OXIR, this mechanism is thought to suppress the wake drive (FDA, 2019).

Major Interactions

• Concomitant use with moderate (verapamil and fluconazole) or strong (clarithromycin and itraconazole) CYP3A inhibitors should be avoided (Ardeljan & Hurezeanu, 2020; FDA, 2019).
• CYP3A inhibitors may increase the side effects of Dayvigo.
• The maximum dose of the drug when co-administered with weak CYP3A inhibitors is 5 mg (Ardeljan & Hurezeanu, 2020; FDA, 2019).
• Concomitant use with strong CYP3A inducers (carbamazepine, rifampin, and St. John’s wort) or moderate CYP3A inducers (efavirenz, bosentan, modefinil, and etravirine) should be avoided (Ardeljan & Hurezeanu, 2020; FDA, 2019).

Side Effects

Dayvigo may cause a number of side effects including:

• Drowsiness, which is the most common side effect (FDA, 2020).
• Impaired ability to operate machinery and decreased daytime alertness (FDA, 2020).
• Sleep paralysis (this is temporary inability to talk or walk while waking up or while going to sleep) (FDA, 2020).
• Complex sleep behaviors including sleep-driving and sleep-walking.
• Hallucinations, which occur while waking up or going to sleep (FDA, 2020).
• Suicidal thoughts and worsening depression (FDA, 2020).
• Compromised respiratory function (FDA, 2019).

Contraindications

• Dayvigo is contraindicated in patients with narcolepsy (FDA, 2019).