DAYVIGO 5 mg/1
lemborexant · TABLET, FILM COATED · Eisai Inc.
DAYVIGO is a tablet, film coated containing lemborexant at 5 mg/1, taken oral. Manufactured by Eisai Inc..
Key Facts
- Brand Name
- DAYVIGO
- Generic Name
- lemborexant
- NDC Code (Product)
62856-405- Manufacturer
- Eisai Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA212028
- Drug Class
- Orexin Receptor Antagonist [EPC]
- Marketing Start
- 04/07/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )] . DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose 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. Dosage may be increased to 10 mg based on clinical response and tolerability. ( 2.1 ) The maximum recommended dose is 10 mg once daily. ( 2.1 ) Time to sleep onset may be delayed if taken with or soon after a meal. ( 2.1 ) Hepatic Impairment: ( 2.3 ) ○ Moderate hepatic impairment: Initial and maximum recommended dosage is 5 mg no more than once per night. ○ Severe hepatic impairment: Not recommended. 2.1 Dosing Information The recommended dosage 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 dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal [see Clinical Pharmacology ( 12.3 )]. 2.2 Dosage Recommendations for Concomitant Use with CYP3A Inhibitors or CYP3A Inducers Co-administration with Strong or Moderate CYP3A Inhibitors Avoid concomitant use of DAYVIGO wit…
Contraindications
4 CONTRAINDICATIONS DAYVIGO is contraindicated in patients with narcolepsy. DAYVIGO is contraindicated in patients with narcolepsy. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors: Avoid concomitant use. ( 7.1 ) Weak CYP3A inhibitors: The maximum recommended dose is 5 mg. ( 2.2 , 7.1 ) Strong or moderate CYP3A inducers: Avoid concomitant use. ( 7.1 ) 7.1 Drugs Having Clinically Important Interactions with DAYVIGO Table 2: Clinically Important Drug Interactions with DAYVIGO Effect of Other Drugs on DAYVIGO Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Dosage and Administration ( 2.2 )]. The maximum recommended dose of DAYVIGO with weak CYP3A inhibitors is 5 mg [see Dosage and Administration ( 2.2 )]. Examples: Strong CYP3A inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which ma…
Adverse Reactions
6 ADVERSE REACTIONS 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 ( 5.1 )] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions ( 5.2 )] Complex Sleep Behaviors [see Warnings and Precautions ( 5.3 )] Patients with Compromised Respiratory Function [see Warnings and Precautions ( 5.4 )] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions ( 5.5 )] The most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 w…
Frequently Asked Questions
What is DAYVIGO used for?
DAYVIGO contains lemborexant. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is DAYVIGO a controlled substance?
Yes, DAYVIGO is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for DAYVIGO?
The generic name for DAYVIGO is lemborexant. There are no other listed brand versions of lemborexant.
What is the NDC code for DAYVIGO 5 mg/1?
The NDC (National Drug Code) for DAYVIGO 5 mg/1 is 62856-405, listed by Eisai Inc..
Other DAYVIGO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)