Shift-Work Related Sleep DisturbancePhase 4NCT05344443
Lemborexant Shift Work Treatment Study
A Phase 4 study testing Lemborexant in people with Shift-Work Related Sleep Disturbance, run by University of California, San Francisco at 1 site in United States.
Trial summary
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Shift-Work Related Sleep Disturbance
- What is being tested?
- Lemborexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 30 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Full-time night shift work (at least 6 hours per shift, 4 days per week or 32 hours per week)
- Employed as a night shift worker for at least 3 months
- Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
Who cannot join
- Pregnancy (verified by urine pregnancy test) or plan to become pregnant in the next 3 months
- Currently breastfeeding
- Inadequate opportunity for sleep during the daytime (< 7 hours opportunity) after overnight shift
- Extreme circadian preference (based on Horne \& Ostberg Morningness-Eveningness Questionnaire)
- Severe depressive symptoms (>25 on CES-D)
- Unwillingness to discontinue sleep aids (prescription or non-prescription) during the study period
Show all 12Show fewer
- Presence of sleep disordered breathing (verified by Apnea link)
- Self-reported diagnosis of narcolepsy, restless legs syndrome
- Self-reported intake of >600mg of caffeine per night shift or use of stimulants during night shift, rotational, or irregular shifts
- Unstable or untreated medical or psychiatric condition based on clinical interview.
- Severe hepatic or renal impairment (based on chemistry panel);
- Self-reported use of digoxin or strong or moderate cytochrome P450 3A4 isozyme inhibitors or cytochrome P450 3A4 isozyme inducers for 6 months prior to or during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
Read the detailed description
Insomnia and daytime sleepiness are common complaints among night shift workers. A meta-analysis on sleep in shift workers indicates that fixed night shift workers sleep, on average, 0.4 hours less than fixed day shift workers, while rotating shift workers sleep on average 1 hour less than fixed day shift workers. While there may be several reasons for sleep difficulties and sleep loss among shift workers, the misalignment of one's sleep preference (i.e., goal of sleeping during the day) and one's circadian rhythm (i.e., endogenous rhythm that signals the body to be awake during the day) is thought to be a primary cause. Insufficient sleep among night shift and rotating shift workers is linked with significant health consequences, including elevated risk for cardiovascular disease and cancer. Effective sleep treatments in shift workers are lacking. However, a recent randomized study of Suvorexant (20mg), a hypocretin/orexin receptor antagonist, produced a significant improvement in daytime total sleep time compared to placebo. Available evidence suggests that the reason Suvorexant is effective is because it blocks the hypocretin/orexin receptors that mediate signaling from the biological clock (suprachiasmatic nucleus of the hypothalamus) attempting to maintain sustained wakefulness during the biological day. As Lemborexant is also a hypocretin/orexin antagonist, it would also be expected to improve daytime sleep in shift workers but would have the advantage over Suvorexant of being highly effective in the dosages available for clinical use. As such, Lemborexant is ideally positioned to be an effective and important treatment of sleep problems in shift workers.
The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist.
- Conditions
- Shift-Work Related Sleep Disturbance
- Being tested
- Lemborexant, Placebo
- Keywords
- Shift Work, Daytime Sleepiness, Lemborexant
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Also called Dayvigo
A dual orexin antagonist
PlaceboDrug
A placebo that looks and tastes like Lemborexant tablets
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Participants randomized into this arm will receive Lemborexant (5-10mg). Receives: Drug: Lemborexant |
| Placebo Treatment | Placebo comparator | Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.
Measured: Two weeks of Treatment
Secondary outcomes (1)
Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was collected using daily actigraphy data from Actiwatches, which participants wore during the two week treatment period.
Measured: Two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start10 Mar 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shift-Work Related Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aric Prather, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344443
- Sponsor's protocol ID
- 20-32763
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2022
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prather AA, Mitgang D, Plaut TC, Ovais T, Krystal AD. Effects of lemborexant vs placebo on total daytime sleep in shift workers: a randomized controlled trial. J Clin Sleep Med. 2026 Oct 7;22(1):185. doi: 10.1007/s44470-026-00199-0.
PubMed 42844407
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05344443
- Acronym / sponsor ID
- 20-32763
- Conditions
- Shift-Work Related Sleep Disturbance
- Keywords
- Shift Work, Daytime Sleepiness, Lemborexant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
Detailed description
Insomnia and daytime sleepiness are common complaints among night shift workers. A meta-analysis on sleep in shift workers indicates that fixed night shift workers sleep, on average, 0.4 hours less than fixed day shift workers, while rotating shift workers sleep on average 1 hour less than fixed day shift workers. While there may be several reasons for sleep difficulties and sleep loss among shift workers, the misalignment of one's sleep preference (i.e., goal of sleeping during the day) and one's circadian rhythm (i.e., endogenous rhythm that signals the body to be awake during the day) is thought to be a primary cause. Insufficient sleep among night shift and rotating shift workers is linked with significant health consequences, including elevated risk for cardiovascular disease and cancer. Effective sleep treatments in shift workers are lacking. However, a recent randomized study of Suvorexant (20mg), a hypocretin/orexin receptor antagonist, produced a significant improvement in daytime total sleep time compared to placebo. Available evidence suggests that the reason Suvorexant is effective is because it blocks the hypocretin/orexin receptors that mediate signaling from the biological clock (suprachiasmatic nucleus of the hypothalamus) attempting to maintain sustained wakefulness during the biological day. As Lemborexant is also a hypocretin/orexin antagonist, it would also be expected to improve daytime sleep in shift workers but would have the advantage over Suvorexant of being highly effective in the dosages available for clinical use. As such, Lemborexant is ideally positioned to be an effective and important treatment of sleep problems in shift workers.
The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: LemborexantParticipants randomized into this arm will receive Lemborexant (5-10mg). |
| Placebo Treatment | Placebo comparator | Drug: PlaceboParticipants randomized into this arm will receive a placebo medication which appears the same as the active treatment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full-time night shift work (at least 6 hours per shift, 4 days per week or 32 hours per week)
- Employed as a night shift worker for at least 3 months
- Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
Key exclusion criteria (12 listed)
- Pregnancy (verified by urine pregnancy test) or plan to become pregnant in the next 3 months
- Currently breastfeeding
- Inadequate opportunity for sleep during the daytime (< 7 hours opportunity) after overnight shift
- Extreme circadian preference (based on Horne \& Ostberg Morningness-Eveningness Questionnaire)
- Severe depressive symptoms (>25 on CES-D)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LemborexantAlso: DayvigoA dual orexin antagonist | Drug | Active Treatment |
| PlaceboA placebo that looks and tastes like Lemborexant tablets | Drug | Placebo Treatment |
Primary outcome
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary
Time frame: Two weeks of Treatment
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.
1 secondary outcome
Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy
Time frame: Two weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42844407Prather AA, Mitgang D, Plaut TC, Ovais T, Krystal AD. Effects of lemborexant vs placebo on total daytime sleep in shift workers: a randomized controlled trial. J Clin Sleep Med. 2026 Oct 7;22(1):185. doi: 10.1007/s44470-026-00199-0.
- Study ScreenerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aric Prather, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lemborexant in people with Shift-Work Related Sleep Disturbance, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary (time frame: Two weeks of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.