Lemborexant

Lemborexant has replicated phase 3 evidence for adult insomnia. It improved cognition in one small sleep-impaired shift-worker trial, impaired attention and memory four hours after 10 mg in healthy older adults, and has never shown better-than-normal cognition or longer life.

Dual orexin OX1R/OX2R receptor antagonist

SUNRISE 1 and 2 improved sleep onset and maintenance; the six-month trial added about 19 to 23 minutes of reported total sleep versus placebo.
At four hours, 10 mg impaired selected attention and memory tests in healthy older adults; eight-hour group means were null.
A 47-person 2026 shift-worker trial reported cognitive gains but contains conflicting duration and DSST text.
The US label warns about next-day impairment, complex sleep behavior, mood changes and CYP3A interactions.

What is lemborexant approved to do?

Lemborexant is a dual orexin OX1R/OX2R antagonist approved for adult insomnia in the United States and other named jurisdictions.

It reduces wake drive to help sleep onset and maintenance. Approval covers insomnia treatment with jurisdiction-specific labels; it does not cover cognitive enhancement or dementia prevention.

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

PMDA review · Japanese approval

Regulatory review report

Pharmaceuticals and Medical Devices Agency. Review Report: Dayvigo Tablets 2.5 mg, 5 mg, 10 mg. Review dated November 11, 2019; Japanese approval January 23, 2020.

PMDA reviewed lemborexant clinical and nonclinical evidence and concluded that efficacy for insomnia was demonstrated with an acceptable safety framework for the Japanese authorization.

Participants / model: Adults with insomnia in the Japanese regulatory dossier
Treatment: Oral lemborexant tablets
Follow-up: Regulatory dossier
Study design: PMDA review report
Funding: Sponsor regulatory program

Japanese authorization and conditions are jurisdiction-specific.

Read the original source

China approval announcement · May 2025

Manufacturer regulatory announcement

Eisai Co., Ltd. New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China. May 27, 2025.

Eisai announced that China's NMPA approved lemborexant for adults with insomnia characterized by difficulty with sleep onset and/or maintenance, with launch planned in fiscal 2025.

Participants / model: Adults with insomnia in China
Treatment: Oral lemborexant tablets
Follow-up: Approval announced May 2025
Study design: Manufacturer announcement of NMPA action
Funding: Eisai

China's authorization is separate from FDA approval and does not extend the indication beyond insomnia.

Read the original source

Russia GRLS · registered July 1, 2026

Government medicine-register record

Ministry of Health of the Russian Federation. State Register of Medicines: Dayvigo (lemborexant), registration ЛП-№(015586)-(РГ-RU). Registered July 1, 2026.

The current Russian register record identifies prescription Dayvigo 5 mg and 10 mg tablets as an active medicine registration for adult insomnia, registration ЛП-№(015586)-(РГ-RU), dated July 1, 2026.

Participants / model: Adults with insomnia under the Russian product information
Treatment: Prescription oral lemborexant tablets
Study design: Government medicine-register record

The Russian authorization is jurisdiction-specific and does not extend the indication to cognition or longevity.

Read the original source

How much did sleep improve?

Two global phase 3 programs improved sleep onset and maintenance, and a 194-person China trial replicated short-term benefit.

SUNRISE 1 randomized 1,006 older adults for one month and improved polysomnographic sleep onset, efficiency and late-night maintenance versus placebo.

In SUNRISE 2, 971 were randomized and 959 treated. At six months, sleep-onset latency fell 21.81 minutes with 5 mg and 28.21 with 10 mg versus 11.43 with placebo. Compared with placebo, reported total sleep rose 18.56 and 22.69 minutes. Somnolence occurred in 8.6% and 13.1% versus 1.6%.

SUNRISE 1 · 1006 older adults, one month

Phase 3 randomized clinical trial

Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Network Open. 2019;2(12):e1918254. doi:10.1001/jamanetworkopen.2019.18254. PMID 31880796.

In 1006 randomized adults aged 55 or older, one month of nightly lemborexant improved polysomnographic sleep onset, sleep efficiency, and wake after sleep onset versus placebo; late-night wakefulness measures also favored lemborexant over zolpidem extended release on specified comparisons.

Participants / model: 1006 adults aged 55 or older with insomnia; median age about 63, 86.4% women
Treatment: Nightly oral lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg, or placebo
Follow-up: One month
Study design: Randomized, double-blind, placebo- and active-controlled phase 3 trial
Funding: Eisai

Sponsor-funded, short duration, sleep endpoints; it did not test healthy cognitive enhancement or prevention of dementia.

Read the original source

SUNRISE 2 full paper · 971 randomized, 959 treated

Phase 3 randomized clinical trial

Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9):zsaa123. doi:10.1093/sleep/zsaa123. PMID 32585700.

At six months, median subjective sleep-onset latency changed by -11.43 minutes with placebo, -21.81 with 5 mg, and -28.21 with 10 mg; geometric-mean treatment ratios were 0.732 and 0.701 (both p<0.0001). Sleep efficiency improved 4.55 and 4.67 percentage points versus placebo, wake after sleep onset fell 17.47 and 12.67 minutes, and total sleep time rose 18.56 and 22.69 minutes.

Participants / model: 971 adults randomized; 959 treated; 949 in the full analysis set and 947 in the safety analysis
Treatment: Nightly oral lemborexant 5 mg, 10 mg, or placebo
Follow-up: Twelve months, with placebo control for the first six months
Study design: Global multicenter randomized double-blind phase 3 trial
Funding: Eisai

At least one treatment-emergent adverse event occurred in 62.7% placebo, 61.1% 5 mg, and 59.6% 10 mg; somnolence occurred in 1.6%, 8.6%, and 13.1%. Treatment-related events and discontinuations increased with dose. Outcomes were subjective diaries, and the second six months lacked placebo.

Read the original source

China phase 3 · 194 randomized, one month

Phase 3 randomized controlled trial

Mi WF, Wen D, Xu L, Pan J, Gu P, Wang C, Tang J, Zhang L, Liu CF, Yuan C, Wang H, Yamakawa N, Takase T, Moline M, Lu L. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep Medicine. 2026;139:108722. doi:10.1016/j.sleep.2025.108722. PMID 41442783.

In China, 194 adults were randomized to placebo (n=100) or lemborexant 10 mg (n=94) for one month. Mean sleep-latency change was -39.47 versus -21.71 minutes, with p=0.0096 after a post-hoc Box-Cox transformation; sleep efficiency, total sleep time, and wake after sleep onset also favored lemborexant.

Participants / model: 194 adults with insomnia at 21 mainland-China and 2 Taiwan sites; median age about 42
Treatment: Nightly oral lemborexant 10 mg or placebo
Follow-up: One month plus follow-up
Study design: Multicenter randomized double-blind placebo-controlled phase 3 trial
Funding: Eisai

The primary analysis used a post-hoc transformation, the program tested sleep endpoints over one month, and sponsor employees were authors. This supports insomnia treatment in the studied population, not cognition enhancement.

Read the original source

What did the China trial add?

In 194 adults, one month of 10 mg reduced mean reported sleep latency by 39.47 minutes versus 21.71 with placebo; sleep efficiency, total sleep time and wake after sleep onset also favored treatment.

The primary analysis required a post-hoc Box-Cox transformation and sponsor employees were authors. The post-hoc transformation and sponsor authorship reduce confidence in this single regional study.

China phase 3 · 194 randomized, one month

Phase 3 randomized controlled trial

Mi WF, Wen D, Xu L, Pan J, Gu P, Wang C, Tang J, Zhang L, Liu CF, Yuan C, Wang H, Yamakawa N, Takase T, Moline M, Lu L. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep Medicine. 2026;139:108722. doi:10.1016/j.sleep.2025.108722. PMID 41442783.

In China, 194 adults were randomized to placebo (n=100) or lemborexant 10 mg (n=94) for one month. Mean sleep-latency change was -39.47 versus -21.71 minutes, with p=0.0096 after a post-hoc Box-Cox transformation; sleep efficiency, total sleep time, and wake after sleep onset also favored lemborexant.

Participants / model: 194 adults with insomnia at 21 mainland-China and 2 Taiwan sites; median age about 42
Treatment: Nightly oral lemborexant 10 mg or placebo
Follow-up: One month plus follow-up
Study design: Multicenter randomized double-blind placebo-controlled phase 3 trial
Funding: Eisai

The primary analysis used a post-hoc transformation, the program tested sleep endpoints over one month, and sponsor employees were authors. This supports insomnia treatment in the studied population, not cognition enhancement.

Read the original source

Did cognition improve in rotating-shift workers?

In one 2026 randomized trial, MoCA, DSST, and grooved-pegboard changes favored 5 mg among 47 hospital workers with inadequate, poor-quality sleep.

MoCA changed +2.88 versus −0.18, a 3.06-point difference. Dominant- and nondominant-hand pegboard time improved by six seconds with treatment while worsening by one to two seconds with placebo; reported p values were below 0.001.

The article prints the placebo DSST change as −1.36 in its table and +1.36 in the narrative. It also describes three weeks of treatment with six-week follow-up in one place and 42 days of treatment elsewhere. Somnolence occurred in 14/25 versus 6/22 and nightmares in 8/25 versus 3/22. Fitbit sleep, practice effects, multiple endpoints and one center limit confidence.

Efficacy of lemborexant on sleep quality and neurocognitive outcomes among hospital rotating shift workers.

Primary human randomized study

Taweepunturat T et al. Sleep Medicine. 2026. PMID 42284966.

In 47 sleep-impaired rotating-shift workers, 5 mg improved MoCA, DSST and grooved-pegboard changes versus placebo; somnolence and nightmares were more frequent.

Participants / model: 47 hospital rotating-shift workers with poor sleep quality and inadequate sleep opportunity
Follow-up: Source reports three weeks with six-week follow-up in one place and a 42-day treatment interval elsewhere
Study design: Single-center randomized double-blind placebo-controlled trial

The article conflicts on the sign of placebo DSST change and on duration; small sample, multiple endpoints, Fitbit sleep and practice effects limit transfer.

Read the original source

Does lemborexant improve cognition in a rested healthy person?

The cited studies include no enhancement trial. Healthy cognition studies measured impairment and residual safety; dementia studies measured sleep-wake rhythm without showing cognitive improvement.

A four-week Alzheimer trial found no MMSE or ADAS-Cog improvement. A 2026 mild-OSA report is a post-hoc SUNRISE-1 subgroup and found no next-morning cognitive advantage.

No human trial showed dementia prevention, neuroprotection, longer lifespan, greater strength or athletic benefit.

Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants.

Primary human randomized study

Murphy P et al. Journal of Clinical Sleep Medicine. 2020. PMID 32022664.

At four hours, 10 mg impaired selected attention and memory measures; 5 and 10 mg increased body sway. At eight hours, group means no longer differed from placebo on those measures.

Participants / model: 56 healthy older volunteers
Follow-up: Single bedtime doses with four- and eight-hour testing
Study design: Randomized double-blind four-period crossover
Funding: Sponsor-run clinical study.

Morning group-average null results do not guarantee individual safety, and the four-hour result directly measures an impairment window.

Read the original source

On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers.

Primary human randomized study

Vermeeren A et al. Sleep. 2019. PMID 30597112.

At about nine hours after dosing, placebo-adjusted lane-weaving means stayed below the prespecified impairment boundary for all lemborexant conditions; zopiclone confirmed assay sensitivity.

Participants / model: 48 healthy good sleepers aged 23 to 78
Follow-up: Eight consecutive nights per condition
Study design: Randomized double-blind incomplete four-period crossover with active and placebo controls
Funding: Sponsor-run clinical study.

Controlled group means cannot guarantee unimpaired driving after short sleep, alcohol, interacting drugs or later dosing.

Read the original source

Acute Cognitive Effects of the Dual Orexin Receptor Antagonist Lemborexant Compared With Suvorexant and Zolpidem in Recreational Sedative Users.

Primary human randomized study

Landry I et al. Journal of Clinical Psychopharmacology. 2022. PMID 35748777.

Single 10 to 30 mg doses slowed recognition/motor reaction time and reduced divided attention versus placebo through the active window.

Participants / model: 32 healthy nondependent recreational sedative users
Follow-up: Single-dose periods with testing through eight hours
Study design: Randomized double-blind six-way crossover
Funding: Sponsor-run clinical study.

The selected population and supratherapeutic comparator doses make this a pharmacodynamic/abuse-potential study, not an insomnia-benefit comparison.

Read the original source

Safety and Efficacy of Lemborexant in Patients With Irregular Sleep-Wake Rhythm Disorder and Alzheimer's Disease Dementia: Results From a Phase 2 Randomized Clinical Trial.

Primary human randomized study

Moline M et al. Journal of Prevention of Alzheimer’s Disease. 2021. PMID 33336219.

Selected rest-activity measures improved over four weeks; MMSE and ADAS-Cog did not worsen, and cognitive improvement was not established.

Participants / model: 62 people with Alzheimer dementia and irregular sleep-wake rhythm disorder
Follow-up: Four weeks
Study design: Randomized placebo-controlled phase 2 dose-ranging trial

Absence of short cognitive worsening does not show dementia treatment, prevention or longevity.

Read the original source

Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea.

Primary post-hoc human analysis

Gottschalk R et al. Sleep Medicine: X. 2026. PMID 42088939.

In a SUNRISE-1 mild-OSA subgroup, 10 mg improved insomnia severity nominally; next-morning cognition and alertness did not significantly differ.

Participants / model: 410 SUNRISE-1 participants with insomnia and mild untreated OSA
Follow-up: One month
Study design: Post-hoc subgroup analysis of an existing randomized trial

This is not an independent trial and cannot override individual impairment warnings.

Read the original source

What happens during the night and the next morning?

In 56 healthy older volunteers, 10 mg impaired selected attention and memory measures at four hours. Both 5 and 10 mg increased body sway.

At eight hours, group means no longer differed from placebo on that cognitive battery or body sway. A separate sedative-user crossover found slower reaction time and worse divided attention through eight hours at 10 to 30 mg.

These results identify an active impairment window and a later group-average null. They do not guarantee that every person is safe the next morning.

Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants.

Primary human randomized study

Murphy P et al. Journal of Clinical Sleep Medicine. 2020. PMID 32022664.

At four hours, 10 mg impaired selected attention and memory measures; 5 and 10 mg increased body sway. At eight hours, group means no longer differed from placebo on those measures.

Participants / model: 56 healthy older volunteers
Follow-up: Single bedtime doses with four- and eight-hour testing
Study design: Randomized double-blind four-period crossover
Funding: Sponsor-run clinical study.

Morning group-average null results do not guarantee individual safety, and the four-hour result directly measures an impairment window.

Read the original source

Acute Cognitive Effects of the Dual Orexin Receptor Antagonist Lemborexant Compared With Suvorexant and Zolpidem in Recreational Sedative Users.

Primary human randomized study

Landry I et al. Journal of Clinical Psychopharmacology. 2022. PMID 35748777.

Single 10 to 30 mg doses slowed recognition/motor reaction time and reduced divided attention versus placebo through the active window.

Participants / model: 32 healthy nondependent recreational sedative users
Follow-up: Single-dose periods with testing through eight hours
Study design: Randomized double-blind six-way crossover
Funding: Sponsor-run clinical study.

The selected population and supratherapeutic comparator doses make this a pharmacodynamic/abuse-potential study, not an insomnia-benefit comparison.

Read the original source

What did the on-road driving trial show?

In 48 healthy good sleepers, placebo-adjusted lane weaving about nine hours after bedtime dosing stayed below the prespecified impairment boundary for 2.5, 5 and 10 mg; zopiclone confirmed the test could detect impairment.

All 48 completed and no lemborexant drive was stopped. The result applies to controlled sleep opportunity and group means; short sleep, alcohol, interacting drugs, later dosing and individual sensitivity change the risk.

On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers.

Primary human randomized study

Vermeeren A et al. Sleep. 2019. PMID 30597112.

At about nine hours after dosing, placebo-adjusted lane-weaving means stayed below the prespecified impairment boundary for all lemborexant conditions; zopiclone confirmed assay sensitivity.

Participants / model: 48 healthy good sleepers aged 23 to 78
Follow-up: Eight consecutive nights per condition
Study design: Randomized double-blind incomplete four-period crossover with active and placebo controls
Funding: Sponsor-run clinical study.

Controlled group means cannot guarantee unimpaired driving after short sleep, alcohol, interacting drugs or later dosing.

Read the original source

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

Why can bedtime timing and interactions matter the next day?

The FDA label reports peak concentration around one to three hours and effective half-life about 17 hours at 5 mg and 19 hours at 10 mg.

Strong or moderate CYP3A inhibitors raise exposure, and inducers can lower it. The label warns against alcohol and other CNS depressants. A long half-life does not predict one person’s driving or cognition by itself.

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

Which risks need to stay beside the sleep benefit?

The label warns about CNS depression and next-day impairment, complex sleep behavior, sleep paralysis or hallucinations, cataplexy-like symptoms, worsening depression or suicidal thinking, respiratory caution and CYP3A interactions.

Narcolepsy is a contraindication. Alcohol plus lemborexant worsened several cognitive measures versus lemborexant alone in a crossover whose complete four-treatment analysis included 18 people.

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

Effect of alcohol coadministration on the pharmacodynamics, pharmacokinetics, and safety of lemborexant: A randomized, placebo-controlled crossover study.

Primary human randomized interaction study

Landry I et al. Journal of Psychopharmacology. 2022. PMID 35634694.

Alcohol plus lemborexant worsened several cognitive measures versus lemborexant alone; the prespecified complete four-treatment analysis included 18 participants.

Participants / model: 32 healthy adults enrolled; 18 completed all four treatments for the prespecified pharmacodynamic set
Follow-up: Single-dose conditions
Study design: Randomized placebo-controlled crossover interaction study
Funding: Sponsor-run clinical study.

The body-sway comparison versus alcohol alone did not separate, but the cognitive interaction and label warning remain relevant.

Read the original source

SUNRISE 2 full paper · 971 randomized, 959 treated

Phase 3 randomized clinical trial

Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9):zsaa123. doi:10.1093/sleep/zsaa123. PMID 32585700.

At six months, median subjective sleep-onset latency changed by -11.43 minutes with placebo, -21.81 with 5 mg, and -28.21 with 10 mg; geometric-mean treatment ratios were 0.732 and 0.701 (both p<0.0001). Sleep efficiency improved 4.55 and 4.67 percentage points versus placebo, wake after sleep onset fell 17.47 and 12.67 minutes, and total sleep time rose 18.56 and 22.69 minutes.

Participants / model: 971 adults randomized; 959 treated; 949 in the full analysis set and 947 in the safety analysis
Treatment: Nightly oral lemborexant 5 mg, 10 mg, or placebo
Follow-up: Twelve months, with placebo control for the first six months
Study design: Global multicenter randomized double-blind phase 3 trial
Funding: Eisai

At least one treatment-emergent adverse event occurred in 62.7% placebo, 61.1% 5 mg, and 59.6% 10 mg; somnolence occurred in 1.6%, 8.6%, and 13.1%. Treatment-related events and discontinuations increased with dose. Outcomes were subjective diaries, and the second six months lacked placebo.

Read the original source

Why does lemborexant remain in A tier?

Multiple phase 3 trials and national approvals support adult insomnia treatment. The A does not cover healthy cognitive enhancement, dementia prevention or longevity.

The shift-worker result comes from 47 people at one center and contains internal reporting conflicts; it needs independent replication.

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

SUNRISE 1 · 1006 older adults, one month

Phase 3 randomized clinical trial

Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Network Open. 2019;2(12):e1918254. doi:10.1001/jamanetworkopen.2019.18254. PMID 31880796.

In 1006 randomized adults aged 55 or older, one month of nightly lemborexant improved polysomnographic sleep onset, sleep efficiency, and wake after sleep onset versus placebo; late-night wakefulness measures also favored lemborexant over zolpidem extended release on specified comparisons.

Participants / model: 1006 adults aged 55 or older with insomnia; median age about 63, 86.4% women
Treatment: Nightly oral lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg, or placebo
Follow-up: One month
Study design: Randomized, double-blind, placebo- and active-controlled phase 3 trial
Funding: Eisai

Sponsor-funded, short duration, sleep endpoints; it did not test healthy cognitive enhancement or prevention of dementia.

Read the original source

SUNRISE 2 full paper · 971 randomized, 959 treated

Phase 3 randomized clinical trial

Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9):zsaa123. doi:10.1093/sleep/zsaa123. PMID 32585700.

At six months, median subjective sleep-onset latency changed by -11.43 minutes with placebo, -21.81 with 5 mg, and -28.21 with 10 mg; geometric-mean treatment ratios were 0.732 and 0.701 (both p<0.0001). Sleep efficiency improved 4.55 and 4.67 percentage points versus placebo, wake after sleep onset fell 17.47 and 12.67 minutes, and total sleep time rose 18.56 and 22.69 minutes.

Participants / model: 971 adults randomized; 959 treated; 949 in the full analysis set and 947 in the safety analysis
Treatment: Nightly oral lemborexant 5 mg, 10 mg, or placebo
Follow-up: Twelve months, with placebo control for the first six months
Study design: Global multicenter randomized double-blind phase 3 trial
Funding: Eisai

At least one treatment-emergent adverse event occurred in 62.7% placebo, 61.1% 5 mg, and 59.6% 10 mg; somnolence occurred in 1.6%, 8.6%, and 13.1%. Treatment-related events and discontinuations increased with dose. Outcomes were subjective diaries, and the second six months lacked placebo.

Read the original source

China phase 3 · 194 randomized, one month

Phase 3 randomized controlled trial

Mi WF, Wen D, Xu L, Pan J, Gu P, Wang C, Tang J, Zhang L, Liu CF, Yuan C, Wang H, Yamakawa N, Takase T, Moline M, Lu L. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep Medicine. 2026;139:108722. doi:10.1016/j.sleep.2025.108722. PMID 41442783.

In China, 194 adults were randomized to placebo (n=100) or lemborexant 10 mg (n=94) for one month. Mean sleep-latency change was -39.47 versus -21.71 minutes, with p=0.0096 after a post-hoc Box-Cox transformation; sleep efficiency, total sleep time, and wake after sleep onset also favored lemborexant.

Participants / model: 194 adults with insomnia at 21 mainland-China and 2 Taiwan sites; median age about 42
Treatment: Nightly oral lemborexant 10 mg or placebo
Follow-up: One month plus follow-up
Study design: Multicenter randomized double-blind placebo-controlled phase 3 trial
Funding: Eisai

The primary analysis used a post-hoc transformation, the program tested sleep endpoints over one month, and sponsor employees were authors. This supports insomnia treatment in the studied population, not cognition enhancement.

Read the original source

Efficacy of lemborexant on sleep quality and neurocognitive outcomes among hospital rotating shift workers.

Primary human randomized study

Taweepunturat T et al. Sleep Medicine. 2026. PMID 42284966.

In 47 sleep-impaired rotating-shift workers, 5 mg improved MoCA, DSST and grooved-pegboard changes versus placebo; somnolence and nightmares were more frequent.

Participants / model: 47 hospital rotating-shift workers with poor sleep quality and inadequate sleep opportunity
Follow-up: Source reports three weeks with six-week follow-up in one place and a 42-day treatment interval elsewhere
Study design: Single-center randomized double-blind placebo-controlled trial

The article conflicts on the sign of placebo DSST change and on duration; small sample, multiple endpoints, Fitbit sleep and practice effects limit transfer.

Read the original source

Studies and sources

FDA label revised 2025 · indication, PK, warnings

FDA prescribing information

U.S. Food and Drug Administration. DAYVIGO (lemborexant) tablets, NDA 212028, prescribing information revised February 2025. Initial U.S. approval 2019.

The label approves lemborexant for adult insomnia characterized by difficulty with sleep onset and/or maintenance, classifies it Schedule IV, identifies competitive OX1R/OX2R antagonism, and provides clinical pharmacology, contraindications, warnings, and interaction instructions.

Participants / model: Adults with insomnia; label safety and special-population data
Treatment: Oral lemborexant tablets
Follow-up: Current product label and clinical program
Study design: FDA prescribing information
Funding: Eisai regulatory program

The label is prescribing evidence for insomnia, not an endorsement for healthy cognition, longevity, or unsupervised use.

Read the original source

PMDA review · Japanese approval

Regulatory review report

Pharmaceuticals and Medical Devices Agency. Review Report: Dayvigo Tablets 2.5 mg, 5 mg, 10 mg. Review dated November 11, 2019; Japanese approval January 23, 2020.

PMDA reviewed lemborexant clinical and nonclinical evidence and concluded that efficacy for insomnia was demonstrated with an acceptable safety framework for the Japanese authorization.

Participants / model: Adults with insomnia in the Japanese regulatory dossier
Treatment: Oral lemborexant tablets
Follow-up: Regulatory dossier
Study design: PMDA review report
Funding: Sponsor regulatory program

Japanese authorization and conditions are jurisdiction-specific.

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China approval announcement · May 2025

Manufacturer regulatory announcement

Eisai Co., Ltd. New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China. May 27, 2025.

Eisai announced that China's NMPA approved lemborexant for adults with insomnia characterized by difficulty with sleep onset and/or maintenance, with launch planned in fiscal 2025.

Participants / model: Adults with insomnia in China
Treatment: Oral lemborexant tablets
Follow-up: Approval announced May 2025
Study design: Manufacturer announcement of NMPA action
Funding: Eisai

China's authorization is separate from FDA approval and does not extend the indication beyond insomnia.

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SUNRISE 1 · 1006 older adults, one month

Phase 3 randomized clinical trial

Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Network Open. 2019;2(12):e1918254. doi:10.1001/jamanetworkopen.2019.18254. PMID 31880796.

In 1006 randomized adults aged 55 or older, one month of nightly lemborexant improved polysomnographic sleep onset, sleep efficiency, and wake after sleep onset versus placebo; late-night wakefulness measures also favored lemborexant over zolpidem extended release on specified comparisons.

Participants / model: 1006 adults aged 55 or older with insomnia; median age about 63, 86.4% women
Treatment: Nightly oral lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg, or placebo
Follow-up: One month
Study design: Randomized, double-blind, placebo- and active-controlled phase 3 trial
Funding: Eisai

Sponsor-funded, short duration, sleep endpoints; it did not test healthy cognitive enhancement or prevention of dementia.

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SUNRISE 2 full paper · 971 randomized, 959 treated

Phase 3 randomized clinical trial

Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9):zsaa123. doi:10.1093/sleep/zsaa123. PMID 32585700.

At six months, median subjective sleep-onset latency changed by -11.43 minutes with placebo, -21.81 with 5 mg, and -28.21 with 10 mg; geometric-mean treatment ratios were 0.732 and 0.701 (both p<0.0001). Sleep efficiency improved 4.55 and 4.67 percentage points versus placebo, wake after sleep onset fell 17.47 and 12.67 minutes, and total sleep time rose 18.56 and 22.69 minutes.

Participants / model: 971 adults randomized; 959 treated; 949 in the full analysis set and 947 in the safety analysis
Treatment: Nightly oral lemborexant 5 mg, 10 mg, or placebo
Follow-up: Twelve months, with placebo control for the first six months
Study design: Global multicenter randomized double-blind phase 3 trial
Funding: Eisai

At least one treatment-emergent adverse event occurred in 62.7% placebo, 61.1% 5 mg, and 59.6% 10 mg; somnolence occurred in 1.6%, 8.6%, and 13.1%. Treatment-related events and discontinuations increased with dose. Outcomes were subjective diaries, and the second six months lacked placebo.

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China phase 3 · 194 randomized, one month

Phase 3 randomized controlled trial

Mi WF, Wen D, Xu L, Pan J, Gu P, Wang C, Tang J, Zhang L, Liu CF, Yuan C, Wang H, Yamakawa N, Takase T, Moline M, Lu L. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep Medicine. 2026;139:108722. doi:10.1016/j.sleep.2025.108722. PMID 41442783.

In China, 194 adults were randomized to placebo (n=100) or lemborexant 10 mg (n=94) for one month. Mean sleep-latency change was -39.47 versus -21.71 minutes, with p=0.0096 after a post-hoc Box-Cox transformation; sleep efficiency, total sleep time, and wake after sleep onset also favored lemborexant.

Participants / model: 194 adults with insomnia at 21 mainland-China and 2 Taiwan sites; median age about 42
Treatment: Nightly oral lemborexant 10 mg or placebo
Follow-up: One month plus follow-up
Study design: Multicenter randomized double-blind placebo-controlled phase 3 trial
Funding: Eisai

The primary analysis used a post-hoc transformation, the program tested sleep endpoints over one month, and sponsor employees were authors. This supports insomnia treatment in the studied population, not cognition enhancement.

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Russia GRLS · registered July 1, 2026

Government medicine-register record

Ministry of Health of the Russian Federation. State Register of Medicines: Dayvigo (lemborexant), registration ЛП-№(015586)-(РГ-RU). Registered July 1, 2026.

The current Russian register record identifies prescription Dayvigo 5 mg and 10 mg tablets as an active medicine registration for adult insomnia, registration ЛП-№(015586)-(РГ-RU), dated July 1, 2026.

Participants / model: Adults with insomnia under the Russian product information
Treatment: Prescription oral lemborexant tablets
Study design: Government medicine-register record

The Russian authorization is jurisdiction-specific and does not extend the indication to cognition or longevity.

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Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants.

Primary human randomized study

Murphy P et al. Journal of Clinical Sleep Medicine. 2020. PMID 32022664.

At four hours, 10 mg impaired selected attention and memory measures; 5 and 10 mg increased body sway. At eight hours, group means no longer differed from placebo on those measures.

Participants / model: 56 healthy older volunteers
Follow-up: Single bedtime doses with four- and eight-hour testing
Study design: Randomized double-blind four-period crossover
Funding: Sponsor-run clinical study.

Morning group-average null results do not guarantee individual safety, and the four-hour result directly measures an impairment window.

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On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers.

Primary human randomized study

Vermeeren A et al. Sleep. 2019. PMID 30597112.

At about nine hours after dosing, placebo-adjusted lane-weaving means stayed below the prespecified impairment boundary for all lemborexant conditions; zopiclone confirmed assay sensitivity.

Participants / model: 48 healthy good sleepers aged 23 to 78
Follow-up: Eight consecutive nights per condition
Study design: Randomized double-blind incomplete four-period crossover with active and placebo controls
Funding: Sponsor-run clinical study.

Controlled group means cannot guarantee unimpaired driving after short sleep, alcohol, interacting drugs or later dosing.

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Acute Cognitive Effects of the Dual Orexin Receptor Antagonist Lemborexant Compared With Suvorexant and Zolpidem in Recreational Sedative Users.

Primary human randomized study

Landry I et al. Journal of Clinical Psychopharmacology. 2022. PMID 35748777.

Single 10 to 30 mg doses slowed recognition/motor reaction time and reduced divided attention versus placebo through the active window.

Participants / model: 32 healthy nondependent recreational sedative users
Follow-up: Single-dose periods with testing through eight hours
Study design: Randomized double-blind six-way crossover
Funding: Sponsor-run clinical study.

The selected population and supratherapeutic comparator doses make this a pharmacodynamic/abuse-potential study, not an insomnia-benefit comparison.

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Efficacy of lemborexant on sleep quality and neurocognitive outcomes among hospital rotating shift workers.

Primary human randomized study

Taweepunturat T et al. Sleep Medicine. 2026. PMID 42284966.

In 47 sleep-impaired rotating-shift workers, 5 mg improved MoCA, DSST and grooved-pegboard changes versus placebo; somnolence and nightmares were more frequent.

Participants / model: 47 hospital rotating-shift workers with poor sleep quality and inadequate sleep opportunity
Follow-up: Source reports three weeks with six-week follow-up in one place and a 42-day treatment interval elsewhere
Study design: Single-center randomized double-blind placebo-controlled trial

The article conflicts on the sign of placebo DSST change and on duration; small sample, multiple endpoints, Fitbit sleep and practice effects limit transfer.

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Safety and Efficacy of Lemborexant in Patients With Irregular Sleep-Wake Rhythm Disorder and Alzheimer's Disease Dementia: Results From a Phase 2 Randomized Clinical Trial.

Primary human randomized study

Moline M et al. Journal of Prevention of Alzheimer’s Disease. 2021. PMID 33336219.

Selected rest-activity measures improved over four weeks; MMSE and ADAS-Cog did not worsen, and cognitive improvement was not established.

Participants / model: 62 people with Alzheimer dementia and irregular sleep-wake rhythm disorder
Follow-up: Four weeks
Study design: Randomized placebo-controlled phase 2 dose-ranging trial

Absence of short cognitive worsening does not show dementia treatment, prevention or longevity.

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Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea.

Primary post-hoc human analysis

Gottschalk R et al. Sleep Medicine: X. 2026. PMID 42088939.

In a SUNRISE-1 mild-OSA subgroup, 10 mg improved insomnia severity nominally; next-morning cognition and alertness did not significantly differ.

Participants / model: 410 SUNRISE-1 participants with insomnia and mild untreated OSA
Follow-up: One month
Study design: Post-hoc subgroup analysis of an existing randomized trial

This is not an independent trial and cannot override individual impairment warnings.

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Effect of alcohol coadministration on the pharmacodynamics, pharmacokinetics, and safety of lemborexant: A randomized, placebo-controlled crossover study.

Primary human randomized interaction study

Landry I et al. Journal of Psychopharmacology. 2022. PMID 35634694.

Alcohol plus lemborexant worsened several cognitive measures versus lemborexant alone; the prespecified complete four-treatment analysis included 18 participants.

Participants / model: 32 healthy adults enrolled; 18 completed all four treatments for the prespecified pharmacodynamic set
Follow-up: Single-dose conditions
Study design: Randomized placebo-controlled crossover interaction study
Funding: Sponsor-run clinical study.

The body-sway comparison versus alcohol alone did not separate, but the cognitive interaction and label warning remain relevant.

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Why is Lemborexant in A tier?

A applies to adult insomnia, backed by replicated phase 3 sleep outcomes and regulated products. A small shift-worker cognition signal needs replication; healthy-rested enhancement, dementia prevention, strength and longevity have not been shown.