Dayvigo

What Is Dayvigo?

Dayvigo (lemborexant) is an orexin receptor antagonist used to treat adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

What Are Side Effects of Dayvigo?

Side effects of Dayvigo include:

• drowsiness,
• headache, and
• nightmares or abnormal dreams

Dosage for Dayvigo

The recommended dose of Dayvigo is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dosage of Dayvigo may be increased to 10 mg based on clinical response and tolerability.

Dayvigo In Children

The safety and effectiveness of Dayvigo have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Dayvigo?

Dayvigo may interact with other medicines such as:

• itraconazole,
• clarithromycin,
• fluconazole,
• verapamil,
• rifampin,
• carbamazepine,
• St. John's wort,
• bosentan,
• efavirenz,
• etravirine,
• modafinil,
• alcohol,
• bupropion, and
• methadone

Tell your doctor all medications and supplements you use.

Dayvigo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Dayvigo; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to Dayvigo during pregnancy. It is unknown if Dayvigo passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Dayvigo (lemborexant) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Dayvigo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

• trouble moving or talking when you first wake up;
• a weak feeling in your legs;
• unusual thoughts or behavior;
• anxiety, agitation, depression;
• memory problems;
• confusion, hallucinations; or
• worsening depression or thoughts about hurting yourself.

Older adults have a higher risk of falls due to drowsiness caused by lemborexant.

Common side effects may include:

• drowsiness during the day after taking lemborexant.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dayvigo (Lemborexant Tablets)

 

Dayvigo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in detail in other sections of the labeling:

• CNS Depressant Effects and Daytime Impairment [see WARNINGS AND PRECAUTIONS]
• Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see WARNINGS AND PRECAUTIONS]
• Complex Sleep Behaviors [see WARNINGS AND PRECAUTIONS]
• Patients with Compromised Respiratory Function [see WARNINGS AND PRECAUTIONS]
• Worsening of Depression/Suicidal Ideation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of DAYVIGO was evaluated in 1418 adult patients with insomnia disorder (age 18 to 88 years) from two controlled efficacy trials (Study 1 and Study 2).

Study 1 was a 6-month placebo-controlled trial assessing DAYVIGO 5 or 10 mg once nightly, followed by a 6-month parallel-group extension period in which patients initially treated with DAYVIGO continued on the same dose, and patients who received placebo were re-randomized to receive DAYVIGO 5 or 10 mg once nightly. In Study 1, 434 patients were treated with DAYVIGO for one year. Study 2 was a 30-day placebo- and active-controlled trial assessing DAYVIGO 5 or 10 mg once nightly.

Adverse Reactions Resulting In Discontinuation Of Treatment

The frequencies of discontinuation due to adverse reactions in Study 1 (the first 30 days) and Study 2 were 2.6% and 1.4% for patients treated with 10 mg and 5 mg DAYVIGO, respectively, compared to 1.5% for patients in the placebo group. The most common adverse reactions leading to discontinuation of DAYVIGO were somnolence (1.0% for 10 mg, 0.7% for 5 mg, and 0.4% for placebo) and nightmares (0.3% for 10 mg, 0.3% for 5 mg, and 0% for placebo).

The frequencies of discontinuation due to adverse reactions in the 6-month placebo-controlled period of Study 1 were 8.3% and 4.1% for patients treated with DAYVIGO 10 mg and 5 mg, respectively, compared to 3.8% for patients in the placebo group. The most common reasons for discontinuation of DAYVIGO and occurring in more than one patient within a treatment arm were somnolence (2.9% for 10 mg, 1.0% for 5 mg, and 0.6% for placebo), nightmares (1.3% for 10 mg, 0.3% for 5 mg, and 0% for placebo), and palpitations (0.6% for 10 mg, 0% for 5 mg, and 0% for placebo).

Most Common Adverse Reactions

The most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at least twice the rate of placebo) in Study 1 (the first 30 days) and Study 2 was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, and 1% for placebo).

Table 1 presents the adverse reactions based on the pooled data from the first 30 days of Study 1 (6-month controlled efficacy trial) and Study 2 (1-month controlled efficacy trial) where the incidence was ≥2% in DAYVIGO-treated patients and greater than in placebo-treated patients.

Table 1: Adverse Reactions Reported in ≥2% of DAYVIGO-Treated Patients and at a Greater Frequency than Placebo-Treated Patients During the First 30 Days of Study 1 and Study 2

	Placebo n=528 (%)	DAYVIGO
		5 mg n=580 %	10 mg n=582 %
Somnolence or fatigue*	1.3	6.9	9.6
Headache	3.4	5.9	4.5
Nightmare or abnormal dreams	0.9	0.9	2.2
*Combines preferred terms somnolence, lethargy, fatigue, sluggishness

Other Adverse Reactions Observed During Clinical Trials (Studies 1 And 2)

Other adverse reactions of <2% incidence but greater than placebo are shown below. The following list does not include adverse reactions 1) for which a drug cause was remote, 2) that were so general to be uninformative, or 3) that were not considered to have clinically significant implications.

• Sleep paralysis was reported in 1.6% and 1.3% of patients receiving DAYVIGO 10 mg and 5 mg, respectively, compared to no reports for placebo. Hypnagogic hallucinations were reported in 0.7% and 0.1% of patients receiving DAYVIGO 10 mg and 5 mg, respectively, compared to no reports for placebo [see WARNINGS AND PRECAUTIONS].
• Two events of complex sleep behavior were reported, both in patients receiving DAYVIGO 10 mg [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Dayvigo (Lemborexant Tablets)