What the label lists and what reports show
Lemborexant side effects
Lemborexant's FDA label: “The most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence.” FAERS holds 2,745 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is suicide attempt (148 reports).
- No generic listed
- DEA Schedule IV
Check it at the source: the lemborexant FDA label on DailyMed (effective February 24, 2025, Eisai Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DAYVIGO?See “What is the most important information I should know about DAYVIGO?” DAYVIGO may cause serious side effects, including: temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up. temporary weakness in your legs that can happen during the day or at night. complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Call your healthcare provider right away if you experience a complex sleep behavior. worsening depression and suicidal thoughts have happened during treatment with DAYVIGO. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying. The most common side effect of DAYVIGO is sleepiness. […]
Source: FDA drug label, Eisai Inc., effective February 24, 2025 (SPL set 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence.
From the label: adverse reactions, continuedThe 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 with insomnia disorder (age 18 to 88 years) from two controlled efficacy trials (Study 1 and Study 2). …
Source: FDA drug label, Eisai Inc., effective February 24, 2025 (SPL set 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,745 reports list lemborexant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 326 are coded as a death and 1,206 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lemborexant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions