Sleep therapies and sleep disorders

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Current state

Sleep now has its own research area. Open Insomnia, Obstructive sleep apnea, Narcolepsy & excessive sleepiness, Circadian rhythm disorders, or Restless legs syndrome. This stable hub retains the original evidence, history and full-note destinations; future condition-specific findings belong in the corresponding topic. The October 3 reorganization does not establish a new complete research check.

A 96-trial evidence synthesis supports digital CBT for insomnia, with variable certainty and limited direct comparisons. Vibrance 3 has closed recruitment; orexin agonists and antagonists address different disorders.

Status: active. Initial baseline completed September 12, 2026. Topic ID: sleep.

Focused update — September 14, 2026: Oveporexton’s pivotal trials were published September 9; this is additional reporting of the existing narcolepsy type 1 evidence, not a new approval. U.S. availability remains sponsor-forecast by November, pending DEA scheduling.

The sleep–wake visualization now also covers established insomnia medicines across histamine, melatonin, GABA-A and orexin pathways, plus clearly labeled off-label antidepressants. These are historical baseline references reviewed October 3, 2026; approval, guideline recommendations and trial safety remain separate.

Questions to follow

• Follow formal human development for insomnia, circadian-rhythm disorders, narcolepsy, idiopathic hypersomnia, restless legs syndrome and obstructive sleep apnea (OSA). Include medicines, CBT-I, validated digital therapeutics, light/timing interventions, devices and clinically useful diagnostic methods.
• Distinguish sleep-onset and maintenance measures, insomnia remission, circadian alignment, restless-legs symptoms, daytime function and durable benefit. Track adherence, next-day impairment, dependence/rebound or withdrawal where relevant, and long-term harms; wearable sleep-stage estimates are not proof of clinical improvement.
• Separate airway obstruction, oxygenation, sleepiness, fatigue, cataplexy, functioning and cardiovascular outcomes. An improved sleep-study number is not automatically a demonstrated reduction in heart attacks or accidents.
• Cross-link obesity-mediated OSA treatment with GLP-1s, and antidepressant-related sleep research with newer antidepressants. Label rumors within this topic under the shared rules.

Programs and next milestones

Established insomnia options — baseline evidence added October 3, 2026

This is a focused baseline expansion, not new October clinical news or a complete sleep-topic monitoring run. Trial doses identify the evidence, not individualized dosing instructions.

• Low-dose doxepin (Silenor 3–6 mg): U.S.-approved for sleep maintenance, distinct from antidepressant doses. In the five-week primary trial, reported night-29 PSG wake time was 40.7 minutes with 6 mg and 60.5 with placebo; the raw mean difference is descriptive and no confidence interval is manufactured. Trial, Tables 1–3 · Label
• Ramelteon (Rozerem): U.S.-approved for sleep onset, acting on melatonin receptors. AASM 2017 weakly suggests it, whereas VA/DoD 2025 finds insufficient evidence for or against it. Label
• Suvorexant (Belsomra): An approved orexin antagonist for sleep onset/maintenance. Different DORAs are not assumed interchangeable. Label
• Trazodone: Off-label for insomnia; both guideline sources weakly suggest against chronic-insomnia use. A small crossover study found sleep effects alongside next-day performance impairment. Primary trial
• Mirtazapine: Off-label. DREAMING reported a week-6 adjusted ISI difference of −6.0 points (95% CI −9.0 to −3.0), with no significant benefit from week 12 onward. MIRAGE supplies additional short-term older-adult evidence and tolerability concerns. DREAMING · MIRAGE

VA/DoD 2025 guideline · AASM 2017 pharmacologic guideline

Baseline evidence; not new trial news. The explorer now distinguishes GABA-A modulation from orexin blockade. Zolpidem immediate release (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata/generics) represent Z-drugs; temazepam (Restoril) and triazolam (Halcion) represent benzodiazepines. Each entry identifies its formulation, approved insomnia use, trial follow-up, selected placebo-controlled adverse-event percentages and limitations. Ambien immediate release has a sleep-initiation indication; its evidence must not be transferred to Ambien CR. Zaleplon primarily addresses onset. Eszopiclone has controlled evidence through six months, which does not establish lasting remission after stopping.

Guidelines and approval remain separate. AASM 2017 gives weak recommendations for these agents in specified symptom patterns. VA/DoD 2025, recommendations 8–10 favors CBT-I as first-line and includes the three Z-drugs among conditional medication options, while suggesting against benzodiazepines for chronic insomnia. The two benzodiazepine labels specify short-term treatment, generally 7–10 days.

Safety context. The FDA Z-drug warning concerns complex sleep behaviors capable of serious injury or death. The benzodiazepine class warning covers abuse/addiction, dependence and potentially life-threatening withdrawal. Label adverse-event percentages are within-trial context and must not become a cross-drug ranking. No new efficacy plot or inferred confidence interval has been added for these five agents.

Sources: Ambien IR label, Lunesta label, six-month eszopiclone randomized trial, 2003, generic zaleplon label, Restoril label, Halcion label. Current labels checked 2026-10-03; individual label revision/posting dates are retained in the explorer.

Additional checked primary sources: Mayer et al., six-month ramelteon trial, March 2009 · Herring et al., two three-month suvorexant trials, 2016 · Trazodone U.S. prescribing information, revised March 2026 · Remeron U.S. prescribing information, revised November 2021

Focused update — 2026-10-02

Digital CBT for insomnia retains the clearest support in a large evidence synthesis

Source/event date: 2026-09-28. Evidence: Peer-reviewed systematic review and network meta-analysis; appraisal of previously flagged lead.

A September 28 network meta-analysis of 96 randomized trials (18,419 adults) compared six types of digital insomnia intervention. Digital CBT reduced Insomnia Severity Index scores by 4.24 points versus pooled controls (95% CI 3.65–4.83 points lower; moderate certainty), reaching the authors' four-point clinically important threshold. The ISI analysis itself included 72 trials and 14,405 people. Some other sleep measures improved statistically without reaching the review's chosen clinical thresholds. Direct comparisons were sparse, rankings imprecise, and populations and control conditions varied. Only two trials were judged low risk of bias; most had some concerns or high risk. This supports digital CBT's evidence base; it does not establish a particular app's clearance, universal remission, superiority to medication, or durable benefit for every patient. This is a synthesis of existing trials, not a new 18,419-person treatment trial.

Next milestone: No specific readout date announced; direct comparisons and durable clinical outcomes remain gaps

Source 1.

Vibrance 3 is now active but no longer recruiting

Source/event date: 2026-09-25. Evidence: Trial registry update.

The September 25 record for Vibrance 3 (NCT06843590) lists active, not recruiting, replacing the notebook's earlier recruiting snapshot. This randomized phase 2 study tests alixorexton (ALKS 2680), an orexin-2 receptor agonist, in idiopathic hypersomnia; planned enrollment remains 126. Primary and final completion remain November 2026 registry estimates. The status change does not establish completion, results, an announced public readout date or U.S. approval.

Next milestone: November 2026 primary/final completion — registry estimates; public readout timing unconfirmed

Source 1.

Coverage: digital insomnia therapy network meta analysis September 28 2026 s12916-026-05129-8; Orzeyful availability November 2026 DEA Federal Register; alixorexton Vibrance 3 ClinicalTrials.gov; restless legs syndrome September 2026 RLS Science Outcomes Summit TOMAC; site:reddit.com/r/Narcolepsy September 2026 new medication Japan Orzeyful.

Remaining gaps: DEA scheduling was searched but not independently established from a final official action. RLS conference full presentations, circadian studies, all new digital products and broad sleep registries were not comprehensively appraised. September 16 venous radiofrequency ablation observational RLS paper full methods not appraised; do not promote as established treatment evidence.

Informal-source coverage: https://www.reddit.com/r/Narcolepsy/comments/1wr7at2/new_medication_made_in_japan/; September 27 discussion repeats expected November access, with no independently verified new U.S. price or launch. https://www.reddit.com/r/Narcolepsy/comments/1whl8i0/did_anyone_here_participate_in_the_clinical/; Trial-participant anecdotes were not treated as efficacy or population safety results.

Next update: Vibrance 3 completion November 2026 registry estimate; Orzeyful launch conditional on scheduling; AD109 FDA target February 28, 2027.

Full coverage record.

Focused update — 2026-09-27

No additional finding was verified in the reviewed sources. Coverage remains partial; this is not a full-topic “no news” conclusion.

Coverage: Orzeyful availability checked and three Brilliance orexin-agonist registry records refreshed; selected insomnia, apnea and hypersomnolence news searches.

Remaining gaps: No complete insomnia, CBT-I/digital therapy, circadian or restless-legs study refresh. Orzeyful actual launch and DEA scheduling not verified; manufacturer still describes forthcoming availability. Full conference abstracts and safety-label changes not comprehensively reviewed.

Informal-source coverage: September 27 narcolepsy discussion repeats a November expectation pending scheduling, not verified launch: https://www.reddit.com/r/Narcolepsy/comments/1wr7at2/new_medication_made_in_japan/. No separate alert for repeated forecast.

Full coverage record.

Focused update — 2026-09-22

Vornorexant long-term insomnia study published

Source date: 2026-09-09. Event date: 2026-09-09. Evidence: Peer-reviewed randomized-dose, open-label study; new publication of established program.

A Japanese 52-week study adds longer-term tolerability data for the dual orexin antagonist vornorexant. 371 participants randomized to 5 or 10 mg; 26-week treatment plus optional 26-week extension. Week-52 subjective sleep-latency change: −31.8 and −44.0 minutes; sleep-efficiency change +15.56 and +20.40 percentage points, respectively.

Limitations: Within-arm change, not placebo-adjusted benefit: no placebo treatment comparator. Optional extension, subjective diaries and unavailable full safety tables limit inference about durable remission, function or comparative effectiveness.

Safety: Somnolence 5.4% (5 mg) and 12.0% (10 mg); nasopharyngitis 10.9% and 8.2%. No withdrawal/rebound of clinical concern detected in one-week run-out. Initial/extension discontinuations 38/8; complete extension denominators not in abstract.

U.S. status: Approved in Japan as Vorzzz on August 25, 2025 (historical context); no U.S. approval verified. Antagonist for insomnia, distinct from orexin agonists for hypersomnolence.

Next milestone: No new dated efficacy readout verified.

Original study abstract; Study DOI; Taisho Japanese approval announcement, September 1, 2025; PMDA approvals listing.

Coverage: Read full topic and Sep18/Sep19 updates. Verified new vornorexant publication/Japan approval context; rechecked Orzeyful official pending-availability language, FDA label and Federal Register API for scheduling; inspected current original Brilliance3/Vibrance3/Neuro-DORA registry records. Targeted insomnia, OSA, hypersomnolence, circadian and RLS searches.

Remaining gaps: Federal Register exact-name API searches returned no oveporexton/Orzeyful records; this is a negative search, not proof that no regulatory action exists. November launch remains sponsor forecast pending DEA. Exact vornorexant long-term trial registry/full safety tables not matched. Daridorexant daytime-function study registry/start and tasimelteon hearing outcome remain unresolved. Complete CBT-I/digital/circadian/RLS registry refresh and RLS conference late-breakers incomplete. Wearable insomnia meta-analysis identified as secondary synthesis, not a new drug trial; no new primary-result claim promoted.

Informal-source coverage: Recent Reddit Orzeyful threads mostly repeat pending launch, access concerns and individual experiences; no independently supported new launch/scheduling rumor extracted. Seltorexant gray-market material excluded. Original podcast sweep incomplete.

Full coverage record.

Next update: Orzeyful scheduling/launch remains unverified; AD109 FDA target February 28, 2027. Vornorexant next comparative or U.S. development milestone undated.

September 19, 2026 — Sleep–wake explorer source check

Focused source verification for a two-condition explainer: adult insomnia and narcolepsy type 1. This does not constitute a complete sleep-topic review or advance the last successful all-topic check.

• Oveporexton regulatory precision: The August 5 FDA approval letter says that the statutory approval date and marketing depend on the DEA scheduling notice and amended labeling. The live U.S. product page still forecasts availability by November 2026, pending scheduling. Prefer “FDA approval announced; scheduling pending” to an unqualified availability claim. No actual launch was verified.
• Plot anchors: Selected month-3 daridorexant nighttime wakefulness and week-12 oveporexton daytime wakefulness results were checked directly against their labels. Endpoints, dose, sample, placebo difference and confidence interval are recorded in the explorer evidence file. These are separate within-trial examples, not a ranking. Daridorexant label; oveporexton label.
• Mechanism and alternatives: Rechecked current lemborexant and pitolisant labels. DORA clinical-mechanism wording remains “presumed”; pitolisant's exact clinical mechanism remains unclear. Retained the AASM recommendation for multicomponent CBT-I and distinction from sleep hygiene alone.
• Alixorexton limit: The August 24 sponsor announcement confirms phase 3 development and describes the phase 2 publication. Full journal text and original registry API fields were inaccessible in this check; no new registry status, approval or comparative safety claim is inferred.

Coverage is limited to the named primary labels, regulatory letter, guideline and sponsor sources. Existing OSA, circadian and restless-legs coverage is unchanged; no new broad surveillance claim is made.

Focused update — 2026-09-18

Neuro-DORA studies sleep treatment and neurodegeneration biomarkers

Source date: 2026-09-18. Evidence: recovered baseline; current registry update.

New to this notebook, Neuro-DORA is an existing small trial of lemborexant and blood biomarkers, not a newly launched dementia-prevention trial. NCT06823752, Woolcock Institute Australia; 20 planned adults with insomnia, randomized masked crossover, two weeks lemborexant versus placebo separated by washout. Primary pTau181 ratio; pTau217, amyloid, NfL and GFAP secondary. Actual start May 13, 2025; September 18 record recruiting, no results.

Limitations: Brief biomarker experiment, not dementia incidence, cognitive function or durable insomnia benefit; update alone does not establish a substantive protocol change.

Safety: No results posted; do not infer neuroprotection from study rationale.

U.S. status: Lemborexant/Dayvigo is an insomnia medicine; this study does not add an Alzheimer-prevention indication.

Next milestone: Registry estimate: Completion December 2027; no promised publication date.

Neuro-DORA registry.

Coverage: Read topic; checked narcolepsy/OSA, insomnia drug/CBT-I, circadian and RLS searches. Verified Orzeyful conditional availability and Apnimed September 8 status. Direct Brilliance3 studies, Vibrance3, SynAIRgy and Neuro-DORA records inspected; sleep–Alzheimer biomarker program recovered. This is a focused review, not a complete re-review of every program.

Remaining gaps: No completed DEA scheduling/launch verified; official sponsor still November pending DEA. Daridorexant daytime-function study actual start/registration and tasimelteon hearing outcome remain unresolved after targeted searches. CBT-I/digital/circadian/new RLS coverage selective, not full registry refresh. September 9 daridorexant abstracts are exploratory reanalyses of older trials; full current analysis not appraised. Vibrance3 registry June 24 lists recruiting with November 2026 completion estimate, no results; cannot infer actual current enrollment from stale record. RLS conference September 23–26 newly identified scheduled forum, not guaranteed readout.

Informal-source coverage: Reddit DORA/narcolepsy/RLS queries found personal experiences and repeated reviews, not new trial or approval evidence. Gray-market DORA sourcing result excluded. Original sleep podcast sweep incomplete.

Full coverage record.

Next expected update: Orzeyful availability expected by November 2026, pending DEA scheduling (sponsor forecast); AD109 FDA target February 28, 2027. Other insomnia, circadian and RLS milestones remain undated or need status verification.

September 14, 2026 — focused update

September 9 publication — oveporexton / Orzeyful. Takeda announced NEJM publication of FirstLight and RadiantLight, the 12-week randomized narcolepsy type 1 trials already underlying the approval (168 and 105 participants). This adds peer-reviewed reporting for wakefulness, sleepiness, cataplexy and quality-of-life analyses. Frequent insomnia and urinary symptoms remain important; brief controlled follow-up does not establish long-term comparative benefit. The sponsor announcement and indexed journal abstract were checked, but full text and supplements were inaccessible for independent detailed appraisal. No additional numeric efficacy claims are inferred from the blocked paper. September 9 publication announcement; NEJM paper.

The official U.S. product page still gives expected availability by November 2026, pending DEA scheduling, checked September 14. No completed scheduling action or actual launch was established. This preserves the distinction between publication, approval and practical availability.

Initial evidence brief — September 12, 2026

Current position. This category has two distinct advances: a potential oral treatment targeting airway neuromuscular control in OSA, and an orexin agonist with FDA approval announced for narcolepsy type 1, with statutory approval and marketing contingent on DEA scheduling. They address different disorders and cannot be treated as interchangeable ways to improve everyday sleep. The important research questions now include sustained function, treatment adherence, adverse effects and the populations that benefit.

AD109 / proposed Oxnimbi — Apnimed, OSA. The peer-reviewed SynAIRgy Phase 3 trial, NCT05813275, randomized 646 adults with mild-to-severe OSA who could not tolerate or refused positive airway pressure to aroxybutynin/atomoxetine or placebo for 26 weeks. The main analysis found an apnea–hypopnea index (AHI) difference of −4.0 events/hour (95% CI −6.4 to −1.6), with model-estimated reductions of 44.1% versus 17.6%. Oxygenation improved, but the PROMIS-Fatigue comparison was not significant. Adverse events caused treatment discontinuation in 21.2% versus 3.1%; dry mouth, nausea, insomnia and urinary hesitation were common. This is physiological efficacy with meaningful tolerability limitations, not a cardiovascular-outcomes trial. Published trial / PMID 42148495.

The sponsor's larger 55.6% AHI reduction headline uses an on-treatment analysis; it should not replace the main treatment-policy estimate above. FDA accepted the application on July 14, 2026; Apnimed's September 8 update reconfirms an FDA action target of February 28, 2027. It remains investigational in the U.S.; an accepted filing and proposed brand are not approval. Publication announcement explaining the estimand, current SEC-filed status.

Orzeyful / oveporexton / TAK-861 — Takeda, narcolepsy type 1. FDA announced approval of this oral selective orexin-2 receptor agonist on August 5, 2026. The approval letter makes the statutory approval date and marketing dependent on DEA scheduling; see the September 19 clarification above. The pivotal placebo-controlled, 12-week FirstLight and RadiantLight trials enrolled 168 and 105 participants respectively: NCT06470828, NCT06505031. Its approval concerns adult narcolepsy type 1, not general fatigue, insomnia, narcolepsy type 2 or idiopathic hypersomnia. FDA approval listing, trial design and conference findings.

FDA's label documents better objective wakefulness, subjective sleepiness and cataplexy. In FirstLight, placebo-adjusted Maintenance of Wakefulness Test improvements were 13.8 and 17.2 minutes for the two doses. Important limitations include frequent insomnia and urinary symptoms, creatine-phosphokinase elevations and increased LDL cholesterol. Longer follow-up is needed beyond the controlled 12-week period. Approval and availability are separate: Takeda expected launch after DEA scheduling, which its August 5 announcement anticipated within 90 days. A completed scheduling action or actual launch was not verified here. FDA label, approval and conditional launch statement.

Alixorexton / ALKS 2680 — Alkermes, broader hypersomnolence development. The 92-person Vibrance-1 Phase 2 trial, NCT06358950, had six blinded weeks and an optional seven-week open-label extension. Its publication was announced August 24, 2026: wakefulness and sleepiness improved; cataplexy reduction reached significance in the 6 mg group. Exploratory cognition/fatigue findings need confirmation. Brilliance Phase 3 studies are underway in narcolepsy types 1 and 2 (NCT07455383, NCT07502443, NCT07540897); Vibrance-3 studies idiopathic hypersomnia (NCT06843590). This remains investigational, and a positive extension cannot establish blinded long-term comparative benefit. Publication announcement, program identifiers and extension limitations.

Detection and broader sleep research. Track prospective validation of home tests and wearable alerts against suitable reference testing, including missed cases, false alerts, repeatability and whether detection improves patient outcomes. Keep detection, diagnosis and treatment selection separate. This initial pass did not establish a new diagnostic device or a population-screening benefit. Insomnia-specific development is expanded below; seltorexant's MDD-with-insomnia program remains cross-linked above rather than presented as a general-insomnia approval.

Expanded sleep-therapy baseline — September 12, 2026

This selective expansion adds established treatment anchors and active human-development questions. Older studies and approvals below are baseline context, not new September 2026 news. The original apnea and narcolepsy evidence above is retained.

CBT-I and prescription digital therapy — SleepioRx. Multicomponent cognitive behavioral therapy for insomnia has a strong AASM recommendation; sleep hygiene alone is not an equivalent treatment. FDA cleared prescription Sleepio under K233577 on August 5, 2024, as an adjunct to usual care for chronic insomnia/insomnia disorder in adults. Its clearance summary includes the 336-person CrEDIT randomized trial, comparing digital CBT-I with online sleep-hygiene education, with a primary assessment at 10 weeks and follow-up through 24 weeks. This establishes an adult prescription-product baseline, not evidence for every consumer sleep app. Next: comparative delivery, remission, completion/adherence, durable daytime benefit and access; no firm new readout date verified. AASM guideline, FDA clearance and trial summary, current product description.

Insomnia medicines — daridorexant/Quviviq and the orexin-antagonist class. Daridorexant is U.S.-approved for adult insomnia involving sleep onset and/or maintenance and remains Schedule IV in the current label. Orexin antagonists reduce wake signaling; keep them separate from the orexin agonists being developed for pathological sleepiness. Pediatric use remains investigational. The March 30, 2026 sponsor topline for Phase 2 NCT05423717 included 165 treated children aged 10 to under 18, randomized to three doses or placebo for two weeks; the day-1 polysomnography total-sleep-time dose-response was significant (p=0.0185). This brief, sponsor-reported result cannot establish durable pediatric safety or benefit. Next: full results and the pediatric regulatory pathway. A July 30 sponsor update also forecast a U.S. daytime-functioning label-enabling study starting in the coming weeks; actual start/registration was not verified, and no firm next readout is established. Track new drugs and meaningful comparative results across the class, alongside dependence/rebound, next-day impairment and falls. Current U.S. label, pediatric topline, July development update.

Circadian-rhythm treatment — timing, light and melatonin. Track human studies of appropriately timed light/dark exposure, melatonin-based treatments and phase-guided delivery for defined circadian disorders. A 2024 randomized active-strategy trial, NCT03715465, studied 40 adults with delayed sleep-wake phase disorder for four weeks. Both groups received low-dose melatonin plus evening dim light and sleep scheduling; timing used measured versus estimated dim-light melatonin onset. Several measures improved over time, but measured-phase scheduling was not superior and total sleep time did not meet the multiplicity-adjusted significance threshold. This small study did not compare the entire package with placebo, and its findings do not independently establish bright-light-only efficacy. Next: larger comparisons, sustained phase alignment and daytime function; no dependable new result date verified. Original human study, trial registry.

Circadian drug development — tasimelteon/Hetlioz. Existing U.S. indications are adult Non-24-Hour Sleep-Wake Disorder and defined Smith-Magenis sleep-disturbance populations: capsules at age 16+ and suspension at ages 3–15. This is not a general insomnia or jet-lag approval. An FDA June 3, 2026 hearing notice concerns the proposed refusal of a jet-lag supplemental application; it scheduled a July 20 prehearing conference with the hearing date to follow. Next: verified docket/hearing outcome; the elapsed conference date does not establish completion, a decision or approval. No completed hearing or new firm date was verified in this bounded check. FDA label, internally revised January 2024, official hearing notice.

Restless legs — Nidra/NTX100 nerve stimulation. FDA granted De Novo DEN220059 on April 17, 2023 for a prescription device for medication-refractory moderate-to-severe primary restless legs syndrome. In the 133-person RESTFUL trial, NCT04874155, four blinded weeks produced CGI-I response rates of 45% versus 16% with sham and an IRLS difference of −3.4 points. Discomfort and skin irritation were generally mild; the trial reported no severe or serious device-related adverse events. The extension NCT05196828 was open-label and cannot establish long-term blinded comparative effectiveness. Next: durability, sleep/function, adherence, harms and access; no firm next event date verified. Also discover meaningful human drug and other device developments for RLS rather than limiting the scope to this anchor. FDA authorization, FDA indication review, RESTFUL publication, extension.

Orzeyful availability clarification — checked September 12, 2026. The official U.S. product page states expected availability by November 2026, pending DEA scheduling. This refines the earlier forecast above; it does not verify completed scheduling or launch. The page is a live sponsor statement, not a newly dated approval announcement.

Expected next updates

Dated history

2026-10-02 — Scheduled focused review

2 newly recorded findings or milestones; primary evidence, uncertainty and incomplete coverage are detailed above and in the run record. Full-topic successful-check dates remain unchanged.

• 2026-09-27: 0 sourced entries and 0 cross-topic links from a focused scheduled check. Coverage and remaining gaps.

• 2026-09-22: Focused scheduled research retry; 1 sourced entries and 0 cross-topic links. Coverage and gaps.

September 14, 2026 — focused ad-hoc review

Added the September 9 pivotal oveporexton publication milestone with the full-text access limitation and rechecked the conditional product-availability statement. See the focused update.

Unresolved procedural milestones: Specific searches did not verify a completed tasimelteon jet-lag hearing or a new hearing date; the July 20 prehearing date in the June 3 notice cannot be treated as an outcome. Daridorexant’s forecast U.S. daytime-function study was not matched to a confirmed registration/start.

Coverage: Checked Takeda/product materials, Idorsia/Vanda program searches, DEA-scheduling and hearing leads. CBT-I/digital/circadian/RLS and individual alixorexton/AD109 registries were not comprehensively refreshed. An insomnia discussion of orexin antagonists mainly repeated review findings and anecdotes; no new program rumor was established. This is a focused update, not a full sleep-field census.

Dated findings and coverage

• Checked September 12, 2026: Established this selective baseline using regulator records, original trial abstracts and dated sponsor releases. Some full-text access was unreliable; numerical AD109 findings use the published abstract, while alixorexton uses the sponsor's publication summary. No new rumor was added from incidental search results without further contextual review; this does not imply no rumors exist. Longer-term safety, comparative effectiveness and diagnostic validation remain active follow-ups.

• Selective expansion checked September 12, 2026: Added CBT-I/digital, insomnia-drug, circadian and restless-legs anchors with primary-source links; clarified the live Orzeyful availability forecast. Historical approvals/studies are baseline, not new news. This was not a full refresh of all apnea/orexin programs or a complete rumor search. Follow up daridorexant study-start/registration and tasimelteon hearing status; preserve prior successful full-topic timestamps. See the expansion coverage record.

2026-09-18 — Scheduled focused review

Read topic; checked narcolepsy/OSA, insomnia drug/CBT-I, circadian and RLS searches. Verified Orzeyful conditional availability and Apnimed September 8 status. Direct Brilliance3 studies, Vibrance3, SynAIRgy and Neuro-DORA records inspected; sleep–Alzheimer biomarker program recovered. Original event dates, safety and limitations are retained in the September 18 update above. The complete-topic successful-check date was not advanced because the listed gaps remain. Run record.