# Insomnia

[Home](../README.md) · [Sleep](../WATCHLIST.md#sleep-health) · [Calendar](../MILESTONES.md)

Tags: [Drugs and biologics](../BROWSE.md#drugs) · [Devices and procedures](../BROWSE.md#devices-procedures)

## Current state

Daridorexant has a sponsor-reported pediatric breakthrough designation; approval is still limited to adult insomnia. DARI-DREAM has begun recruiting for a distinct adult study. Guided digital CBT-I results and the SOM001 and CBD programs remain separate; no new durable architecture or safety conclusions follow.

Status: active. Topic ID: `sleep_insomnia`.

## Questions to follow

- Follow difficulty falling asleep, staying asleep and early-morning waking as overlapping symptom patterns; distinguish trial eligibility, approved indication and demonstrated benefit.
- Compare CBT-I, validated digital therapies and medicines through remission, daytime function, durability, adherence and safety, alongside sleep-study measurements.
- Follow measured REM/N3 duration and percentage, fragmentation and within-night timing when reported. More of a stage is not automatically clinical benefit; wearable estimates and EEG-based polysomnography are different evidence.
- Keep orexin antagonists for insomnia separate from orexin agonists for hypersomnolence. Cross-link mental-health-related sleep research rather than merging indications.

## Programs and next milestones

### Focused update — 2026-11-10


<span class="note-anchor" id="note-2026-11-10-daridorexant-pediatric-breakthrough"></span>

#### Idorsia reports pediatric daridorexant breakthrough designation

**Source date:** 2026-11-04. **Recorded in this review:** November 10, 2026. **Evidence:** Newly recovered November 4 sponsor-reported FDA designation; not approval.

**What changed:** Idorsia's November 4 release reports FDA Breakthrough Therapy Designation for daridorexant in insomnia disorder at ages 10 to under 18. This is newly recovered regulatory context, not a November 10 action or fresh efficacy readout. The underlying 165-person Phase 2 trial (NCT05423717) and its first-night polysomnographic sleep-time results are already documented below.

**Limitations and safety:** A development designation supports closer FDA interaction; it does not establish approval or long-term safety. The two-week Phase 2 evidence does not demonstrate durable remission, normal REM/N3 architecture or long-term development and function. Full publication and safety tables remain pending.

**U.S. status:** Adult insomnia approval remains separate. Pediatric use is investigational.

**Next milestone:** The sponsor forecasts starting pediatric Phase 3 in H2 2027; no actual start or new registry ID was verified.

**Sources:** [Source 1](https://www.idorsia.com/investors/news-and-events/media-releases/media-release-details?id=3798577); [Source 2](https://clinicaltrials.gov/study/NCT05423717).

<span class="note-anchor" id="note-2026-11-10-dari-dream-recruiting-start"></span>

#### DARI-DREAM records recruitment and an October start

**Source date:** 2026-11-05. **Recorded in this review:** November 10, 2026. **Evidence:** Newly recovered November 5 Phase 3 registry update; no efficacy readout.

**What changed:** The November 5 NCT07843329 update now lists DARI-DREAM as recruiting and records October 28 as actual start, replacing the elapsed September estimate. Idorsia's October 27 release had already announced first enrollment; preserve the different source dates rather than infer an exact first-dose day. The randomized masked Phase 3 study plans 344 adults with insomnia, compares daridorexant 50 mg with placebo for about three months and measures diary-reported total sleep time at month 3 as primary; daytime symptom and impact questionnaire outcomes are secondary.

**Limitations and safety:** No efficacy or harms tables have posted. Subjective sleep duration and daytime scores are separate from polysomnographic architecture and sustained remission.

**U.S. status:** Adult insomnia approval remains in place; this study does not establish an added daytime-function label claim.

**Next milestones:** November 22, 2027 primary and December 6, 2027 final completion are registry estimates.

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT07843329); [Source 2](https://www.idorsia.com/media/news/news-archive/media-release-details?id=3791556).

### Focused update — 2026-11-06

<span class="note-anchor" id="note-2026-10-29-comisa-guided-digital-cbti-rct"></span>

#### Guided digital CBT-I improves insomnia in a small COMISA trial

**Source date:** 2026-10-29. **Recorded in this review:** November 6, 2026.

**Evidence:** Peer-reviewed randomized human trial; newly recovered original October report.

**What changed:** An AJRCCM accepted manuscript published October 29 (ChiCTR2500099854) randomized 88 people with coexisting insomnia and OSA to six weekly clinician-guided digital CBT-I sessions or sleep-hygiene education. At 3 months, intention-to-treat ISI changes were −9.5 versus −4.0 points (d −1.18, p=0.001), and PSQI−4.9 versus −1.8 (d −0.87, p=0.001). At six-week posttreatment attended polysomnography, AHI changed −6.0 versus+2.0 events/hour (d −0.64, p=0.019).

**Limitations:** Blinded outcome assessment is specified; the abstract does not explain how participants were blinded to different behavioral packages despite the title. Full methods, arm-specific denominators, CIs, PAP/background care and durability beyond 3 months were not appraised. The AHI measurement is at six weeks, not three months. This does not establish OSA cure or cardiovascular protection.

**Safety:** Transient subjective sleepiness increased at weeks 2–4; the abstract reports no functional impairment or sleepiness-related adverse events. This small trial cannot exclude uncommon harms.

**U.S. status:** Behavioral-delivery evidence, not a newly FDA-cleared app or substitute for individualized OSA treatment.

**Next milestones:** Full methods, longer follow-up and replication: date unknown (No firm date verified)

**Sources:** [Primary source](https://academic.oup.com/ajrccm/advance-article/doi/10.1093/ajrccm/aamag567/9004974); [Primary source](https://pubmed.ncbi.nlm.nih.gov/42958645/).

<span class="note-anchor" id="note-2026-11-05-som001-phase2-protocol"></span>

#### SOM001 enters a short controlled chronic-insomnia study

**Source date:** 2026-11-05. **Recorded in this review:** November 6, 2026.

**Evidence:** New trial-registry protocol.

**What changed:** NCT07920185, first posted November 5, plans 45 adults 18–65 with chronic insomnia in a masked randomized Phase 2 trial. It compares coded oral SOM001 variants with placebo and two established but unnamed comparator drugs at low/high doses. Participants take assigned treatments three nights per week for three weeks in a virtual protocol; treatments change each week despite the summary design calling it parallel. Primary measures are adverse-event safety; secondary outcomes separately assess wake after sleep onset, persistent-sleep latency and total sleep time.

**Limitations:** Drug identities, numeric doses and mechanisms are not disclosed. The short regimen does not establish durable remission, dependence risk or long-term safety. Sponsor website claims of safe long-term use/not habit-forming are promotional, not demonstrated by this protocol.

**Safety:** No results; daytime sleepiness, cognition and alertness are planned assessments.

**U.S. status:** Investigational; an FDA-regulated study is not FDA marketing approval.

**Next milestones:** SOM001 estimated start: 2027-02-01 (Registry estimate); SOM001 estimated primary completion: 2027-10-01 (Registry estimate); SOM001 estimated final completion: 2028-02-01 (Registry estimate)

**Sources:** [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT07920185); [Primary source](https://somnumpharma.com/).

<span class="note-anchor" id="note-2026-11-04-avecho-cbd-insomnia-development-forecast"></span>

#### Avecho forecasts completion of a pharmaceutical CBD insomnia trial

**Source date:** 2026-11-04. **Recorded in this review:** November 6, 2026.

**Evidence:** Sponsor development statement; accompanying full video unappraised.

**What changed:** An official November 4 Avecho post accompanying CEO Paul Gavin’s conversation series describes the ongoing Phase 3 TPM-enhanced CBD capsule insomnia program and forecasts completion by end 2027. The page says aJune interim review permitted continuation.

**Limitations:** Continuation is not a positive efficacy readout or a finding that trial risk is cleared. Full video/transcript, original interim tables and exact primary trial registry were not independently appraised in this pass. The statement is attributable to the dated sponsor post, not a guessed video timestamp.

**Safety:** No quantitative harms or efficacy estimate supplied; no generalization to retail CBD products.

**U.S. status:** Australian pharmaceutical development does not establish FDA approval or U.S. availability.

**Next milestones:** TPM-CBD insomnia trial completion, by year end: 2027 (Sponsor forecast November 4)

**Sources:** [Primary source](https://avecho.com.au/investor-centre/news/2026/11/04/watch-now-what-sandoz-saw-in-our-insomnia-capsule/).

**Coverage and remaining gaps:** focused_incomplete; Focused incomplete appraisal. All pages of specified ClinicalTrials.gov discovery were downloaded, plus all176 unique saved named IDs across these ten topics; retrieval does not equal appraisal. Full worldwide literature/non-U.S.-registry, regulatory-label, harms/hold/discontinuation census and original conference/podcast recordings remain incomplete. Preserve full successful-check timestamps and incomplete sleep baseline flags.; Complete SOM001 drug identities/doses and design inconsistency, full COMISA methods/PAP background and trial safety tables, complete Avecho video/transcript/interim data and exact trial registration remain gaps. Older small CBTI-versus-zolpidem trial is already baseline, not new from recent coverage.

**Informal-source coverage:** Original ENLIGHTEN6/TAK360 fragmentation discussions reread as cross-topic anecdotes. Avecho’s dated CEO-post forecast is sponsor-attributed; full video not reviewed, no invented timestamp.

[Full coverage record](../updates/2026-11-06_scheduled_research_update.md).


### Focused update — 2026-11-03

No additional finding was selected from the checked sources. Coverage remains incomplete; this is not a full-topic “no news” conclusion.

**Related findings, recorded once:** [A sham-controlled slow-wave study will measure cognition in MCI](../topics/08_alzheimers.md#note-2026-11-03-slowwave-mci-cognition-device-registration) ([source](https://clinicaltrials.gov/study/NCT07911826)).

**Coverage and remaining gaps:** focused_incomplete. Paginated retrieval is not complete appraisal. Not every returned record, all non-U.S. registers, full papers/supplements, conference audio or original podcasts were reviewed; full successful-check timestamps and incomplete baseline flags must remain unchanged.; Selected pediatric daridorexant CTIS aggregation points to August result documents; original EU result PDFs/full pediatric safety tables were not retrieved, so no new efficacy claim selected.; Sleep/slow-wave MCI NCT07911826 is owned under Alzheimer topic and cross-linked here, avoiding duplicate events. Complete digital/behavioral/drug harms baseline remains incomplete.

**Informal-source coverage:** Original saved Reddit/statement chains selectively revisited; no distinct new source-grounded rumor or material status transition selected. Long-form podcasts and talks were not exhaustively reviewed.

[Full coverage record](../updates/2026-11-03_scheduled_research_update.md).


### Focused update — 2026-10-30

<span class="note-anchor" id="note-2026-10-29-lemborexant-neurosurgery-protocols"></span>

#### Two trials will test single-dose lemborexant before neurosurgery

**Source date:** 2026-10-29. **Recorded in this review:** October 30, 2026.

Two randomized placebo-controlled Phase 2 trials first posted October 29 will test a **single lemborexant 5 mg dose on the night before surgery**: **NCT07903038**, planning 128 people with Parkinson's disease undergoing deep-brain stimulation, and **NCT07903051**, planning 112 people undergoing brain-tumor surgery.

The primary endpoint is preoperative **total sleep time measured by a wrist-worn Huawei device**, not polysomnography. Secondary sleep or surgical measures must be interpreted individually; more device-estimated sleep does not establish normal REM/N3 architecture, durable insomnia remission, or improved postoperative function.

Both records are **not yet recruiting**, with estimated starts **November 1, 2026** and primary completions **December 31, 2027**. These are distinct perioperative-use questions and should not be treated as new chronic-insomnia efficacy results or a new approved surgical indication.

**U.S. status:** Lemborexant has an existing U.S. adult-insomnia indication; these specific perioperative uses are investigational.

**Next milestones:** Perioperative lemborexant trial starts: 2026-11-01 (Registry estimates); Perioperative lemborexant primary completions: 2027-12-31 (Registry estimates).

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT07903038); [Source 2](https://clinicaltrials.gov/study/NCT07903051).

<span class="note-anchor" id="note-2026-09-16-lemborexant-online-experience-baseline"></span>

#### Patient-review analysis highlights tolerability concerns without estimating population rates

**Source date:** 2026-09-16. **Recorded in this review:** October 30, 2026.

**Baseline publication recovered during this review; not an October 29 clinical-trial readout.** A September 16 Sleep Medicine article (DOI **10.1016/j.sleep.2026.109264**) analyzed **260 self-selected Drugs.com lemborexant reviews from 2020–2023**. Rutgers publicized the work October 29.

Seventy reviewers said they had stopped or planned to stop. Perceived benefit and adverse-effect descriptions varied; sleep paralysis was reported more often among discontinuers. These are reviewer reports with selection and reporting bias, not a representative prescribed-patient cohort, verified adherence assessment, controlled comparison, or incidence estimate. They must not be displayed as “27% of all patients discontinue” or as a new clinical-trial adverse-event rate.

This adds a patient-experience research question alongside controlled-trial safety, especially why patients stop and whether distressing parasomnias outweigh perceived benefit for some people. It does not demonstrate a new regulatory safety action or a change to the adult-insomnia indication.

**U.S. status:** Existing adult-insomnia approval unchanged; no newly verified FDA action.

**Sources:** [Source 1](https://pubmed.ncbi.nlm.nih.gov/42822395/); [Source 2](https://www.rutgers.edu/news/why-some-patients-quit-newer-insomnia-medication).

**Coverage and remaining gaps:** Focused partial appraisal through October 30, 2026. Complete retrieval of the specified query and saved named records; incomplete worldwide review. No full successful-check or baseline-completion claim.. Focused appraisal only. All pages of the specified ClinicalTrials.gov query were retrieved, but not every returned record underwent full results/harms appraisal. This is not complete worldwide coverage.; Independent non-U.S. registry searches, a comprehensive publication/hold/discontinuation census, and complete original conference/podcast audio and transcripts remain incomplete. Full successful-check timestamps and incomplete sleep baseline flags must remain unchanged.; Recovered online-review research is self-selected, not a controlled incidence estimate or new FDA safety action.; Insomnia registry terms yield many incidental/perioperative records; complete screening and human-device/digital-therapy safety appraisal remain incomplete.; Perioperative lemborexant wearable total sleep time does not establish polysomnographic architecture or durable insomnia remission.

**Informal-source coverage:** Re-read the existing ENLIGHTEN-6 and TAK-360 original experience threads that overlap insomnia. Symptoms remain unverified individual accounts. The lemborexant online-review paper is a formal analysis of self-selected reports, not an independent confirmation of those trial anecdotes.

[Full coverage record](../updates/2026-10-30_scheduled_research_update.md).


### Focused update — 2026-10-27

<span class="note-anchor" id="note-2026-10-23-daridorexant-pediatric-detailed-phase2"></span>

#### Daridorexant pediatric Phase 2 abstract supplies numerical results

**Source date:** 2026-10-23. **Recorded in this review:** October 27, 2026.

The original Sleep Europe abstract for NCT05423717 provides detail beyond the March sponsor topline. **165 children/adolescents aged 10 to <18 received at least one dose** of daridorexant 10, 25 or 50 mg or placebo for **14 days**; 87 had confirmed or subthreshold ADHD/ASD.

The primary first-dose polysomnographic total-sleep-time dose-response test was positive (p=.02). For 50 mg versus placebo, LS mean increases were **49.6 minutes (95% CI 32.7–66.5)** versus **20.1 (2.8–37.3)**, with a reported between-arm difference **29.6 minutes (5.4–53.7), p=.02**. In the neurodevelopmental-disorder/traits subgroup, the reported difference was **36.3 minutes (3.1–69.5)**. Rounded within-arm estimates should not be recomputed to replace the reported contrasts.

Adverse events were reported in **28%, 17%, 24% and 24%** across 10/25/50 mg/placebo; arm denominators were not supplied in the abstract. Two-week exposure and a first-night primary endpoint cannot establish durable remission, developmental outcomes, rare harms or normal REM/deep-sleep architecture. Idorsia says a manuscript is under review and forecasts pediatric Phase 3 initiation in **H2 2027**. This remains an unstarted forecast, not pediatric approval.

**U.S. status:** Pediatric daridorexant is investigational, separate from adult QUVIVIQ approval.

**Next milestones:** Pediatric Phase 3 initiation: 2027-H2 (Sponsor forecast).

**Sources:** [Source 1](https://www.idorsia.com/media/news/news-archive/media-release-details?id=3790219); [Source 2](https://distribute.congrex.com/from.storage?image=rzbEdMnveFQUKBvWTFZ8145Jeuppjn-YAje6CCr6Bv0R6YMg4HbnSXEoGb6VRnkg0); [Source 3](https://clinicaltrials.gov/study/NCT05423717).

**Coverage and remaining gaps:** Focused partial review; all pages of specified ClinicalTrials.gov discovery retrieved and selected relevant records appraised. Worldwide full-topic review and baseline completion are NOT claimed.. Focused partial appraisal only. Complete ClinicalTrials.gov query retrieval is not exhaustive worldwide evidence review; independent non-U.S. registries, full conference audio/slides, all publications and a complete holds/discontinuations/harms census remain incomplete. Do not advance full successful-check timestamps or sleep baseline-complete flags.; Detailed pediatric abstract recovered; manuscript remains under review, full arm denominators and durable developmental/remission/safety outcomes unknown.; Broad insomnia query includes many incidental sleep references; all1788 retrievals were not clinically appraised. Full architecture/long-term harms and complete conventional-drug/digital-therapy literature remains incomplete.

**Informal-source coverage:** Targeted Reddit and talk/interview leads sampled daridorexant, conventional insomnia drugs and sleep maintenance/onset. No new original informal program or safety signal was selected beyond formal pediatric results; this is not a full transcript or adverse-event census.

[Full coverage record](../updates/2026-10-27_scheduled_research_update.md).


### Focused update — 2026-10-23

<span class="note-anchor" id="note-2026-10-13-daridorexant-comorbid-harms"></span>

#### Small daridorexant clinic cohort highlights tolerability and mood monitoring

An October 13 peer-reviewed Newcastle case-note review followed 38 patients prescribed daridorexant in April 2024–January 2025, through August 31, 2025; 36 had comorbid conditions. Twenty-one (55%) had sustained benefit and wished to continue after 12 weeks. Twenty-one initially reported side effects; 16 discontinued, including nine (24%) because of adverse effects and seven for lack of benefit.

Dreams/hallucinations occurred in seven, fatigue in five, and anxiety, cognitive problems and daytime drowsiness in four each. Three had worsening mood. One patient developed suicidal ideation 2–3 days after initiation with recurrence on rechallenge; this is clinically notable, but the study cannot estimate causal excess risk. A symptom-score improvement reported among selected responders with paired data should not be presented as the whole-cohort effect.

This small uncontrolled retrospective comorbid sample cannot provide population incidence or be ranked against pivotal randomized-trial adverse-event rates. It supplies practical tolerability context, not a new FDA warning, indication or sleep-architecture result.

**Sources:** [Source 1](https://www.cambridge.org/core/journals/bjpsych-bulletin/article/longterm-outcomes-of-daridorexant-in-those-with-comorbid-insomnia/2A88D0A38B9E173FA7FDD18BFF12DE96); [Source 2](https://pubmed.ncbi.nlm.nih.gov/42864752/).

<span class="note-anchor" id="note-2026-10-20-suvorexant-oud-results"></span>

#### Suvorexant OUD recovery trial results: mixed sleep endpoints and more non-serious adverse events

Johns Hopkins NCT04287062 first posted results October 20; the study completed August 15, 2025. Adults in early opioid-use-disorder recovery with sleep disturbance and receiving methadone, buprenorphine or extended-release naltrexone were assigned suvorexant 20 mg nightly (self-titration to 10 mg permitted) or placebo for eight weeks. The registry clarifies **249 screened, 137 entered and assessed for safety, and 131 included in baseline efficacy analyses**; its flow stages and preassignment wording are not fully consistent, so do not report 249 randomized.

Coprimary mixed-model treatment-by-time tests were total sleep time p=.04, wake after sleep onset p=.10, and perceived stress p=.27. Only 101 had week-eight sleep observations. The table gives raw means and standard errors, not an adjusted between-arm minutes benefit with confidence interval; multiplicity and missingness limit a blanket positive interpretation. Reported non-serious adverse events occurred in 36/69 active versus 22/68 placebo recipients, including drowsiness 12/69 versus 6/68 and abnormal dreams 10/69 versus 2/68, through nine weeks; no serious events or deaths were reported.

Actigraphy/diaries do not measure REM/N3 architecture. These results do not establish reduced relapse or a new OUD indication. General insomnia approval and use alongside opioid treatment remain separate clinical questions.

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT04287062).

<span class="note-anchor" id="note-2026-10-19-ai-bbti-registration"></span>

#### AI-assisted brief behavioral insomnia treatment pilot registered

NCT07880561 first posted October 19. Taipei Medical University plans a 60-person randomized, unmasked four-week study. Both groups receive a digital brief behavioral treatment for insomnia app and sleep diary; the experimental group also accesses an independent AI website for personalized sleep education and questions. Chinese Insomnia Severity Index immediately after four weeks is the primary outcome.

The October 20 record was not yet recruiting, with an estimated November 1, 2026 start, July 31, 2027 primary completion and August 31 final completion. This is a test of an AI add-on to a shared behavioral intervention, not evidence that AI replaces CBT-I or improves durable remission, daytime function or safety. The phrase digital therapeutic in a protocol does not establish U.S. FDA clearance or prescription availability.

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT07880561).

**Coverage and remaining gaps:** Focused incomplete coverage. All pages of the specified ClinicalTrials.gov discovery query and saved named records were retrieved on 2026-10-20; retrieval is not exhaustive appraisal of every record or worldwide evidence. Do not advance full successful-check timestamps. Original source dates remain unchanged. Independent non-US registries, complete conference tables/audio, and a comprehensive harms/discontinuation census remain incomplete.; ClinicalTrials.gov discovery: 294 records across 3 retrieved pages; final retrieval errors: []. Named records also retrieved successfully.; Sleep incomplete baselines used 90-day context through October 20; other topics used the last full successful check minus seven days. Earlier October 16 focused checks did not reset that window.; October 23 was a bounded source follow-up only; broad registry discovery remains the October 20 snapshot. No full successful check is claimed.; October 23 bounded follow-up did not retrieve actual tables for the scheduled daridorexant pediatric ECNP presentation. The elapsed schedule is not proof of delivery/results. Full baseline and comparative sleep-architecture coverage remain incomplete.

**Informal-source coverage:** Original informal sources were sampled on October 20; not a comprehensive podcast, social-media, or anonymous-source search. Reposts were not treated as independent confirmation. No resolved claim was inferred from source silence. Sampled DORA/architecture patient discussion; no verified PSG result or new general safety conclusion adopted. Personal responses are not causal trial evidence.

[Full coverage record](../updates/2026-10-23_scheduled_research_update.md).


### Focused update — 2026-10-16

<span class="note-anchor" id="note-2026-10-15-enightfall-cbti-registration"></span>

#### eNightfall will compare stepped digital CBT-I with standard treatment

**eNightfall / NCT07876661, first posted October 15.** Vrije Universiteit Brussel plans a three-arm randomized study in **140 adult cancer survivors with insomnia in Belgium**, comparing guided stepped web-based CBT-I, a standard 10-week web-based CBT-I program, and usual care with a sleep-hygiene leaflet.

Stepped treatment begins with four weeks of lower-intensity coaching; persistent symptoms trigger six more weeks of fuller CBT-I. Primary measures are **ISI severity and protocol-defined remission** after treatment and at **6 and 12 months**. Fatigue, quality of life, healthcare use and productivity are secondary. This tests scalable access and sustained clinical outcomes, not sleep-stage proportions.

The protocol has a threshold inconsistency: the escalation description uses **ISI <11**, while the primary remission definition says **≤11**. Do not silently harmonize these cutoffs. Participants cannot be fully blinded to behavioral content despite the registry’s masking label.

Status remains **not yet recruiting** after an estimated **October 15 start**. Estimated primary completion is **January 1, 2030**, final **April 1, 2030**. No results or superiority claim; this does not establish a new U.S. cleared digital product.

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT07876661).

**Remaining gaps:** Read current canonical scope, shared summaries, state and assigned topic notes. Bounded registry discovery covered July 18–October 16, 2026; prior October 13 findings were deduplicated. Full-topic successful-check dates remain unchanged.; Retrieved all 291 records across 3 pages of the bounded ClinicalTrials.gov query, plus 6 named records. Selected relevant new/changed protocols were appraised; downloading all records does not establish exhaustive safety/results review.; Europe PMC original-literature discovery failed with HTTP 503 for this topic. Targeted primary-source web searches supplied a partial fallback. Worldwide literature, regulators, international registries and complete original conference/podcast recordings remain incomplete.; The new condition baseline remains incomplete. Preceding 90-day registry discovery and selected inherited pivotal context were checked; the full older clinical, label and behavioral/device evidence corpus has not been completed.; Selected eNightfall because it assesses clinical remission and follow-up rather than only laboratory physiology. Prior SMART, DARI-DREAM, COMISA-PEC and BELL-001 entries retained. Established medicine labeling, architecture endpoints and complete CBT-I/digital durability baseline remain incomplete.

**Informal-source coverage:** Targeted insomnia informal searches returned personal experiences and general prescribing discussions, without a distinct new formal development claim selected. TAK-360 nighttime-sleep account is recorded once under hypersomnolence. No rate or architecture effect inferred; full podcast/talk census incomplete.

[Full coverage record](../updates/2026-10-16_scheduled_research_update.md).


### Focused update — 2026-10-13

<span class="note-anchor" id="note-2026-10-13-bell001-registration"></span>

#### A breathing-linked sound application registers a sham-controlled laboratory study

**NCT07872007, newly posted October 13.** Korean investigators list a completed **72-person** randomized participant/investigator-masked study of smartphone **BELL-001 breathing-linked sounds** versus a sham app in adults with insomnia symptoms.

The single laboratory recording lasted **70 minutes**, with rest, active-use and passive stages. Primary outcomes are scalp EEG power and source-estimated connectivity across several frequency bands; heart-rate/variability measures are secondary. These are immediate physiology measurements, not overnight polysomnographic stage proportions, insomnia remission, daytime function or durable clinical benefit. Multiple EEG bands/connections also require a prespecified analysis and multiplicity appraisal.

Actual conduct was **November 18, 2025–February 18, 2026**; primary completion **February 11, 2026**. Registration happened after completion, with **no posted results** or harms rates. “Digital therapeutic” in the record is a product descriptor, not independently verified FDA authorization. Next: primary protocol chronology, full sham comparisons and clinically meaningful follow-up; no release date.

**Sources:** [Source 1](https://clinicaltrials.gov/study/NCT07872007).

**Remaining gaps:** Read current canonical scope, shared summaries/state and assigned topic notes. September 5–October 13 overlap preserves the September 12 full-review dates; October 6/9 entries were deduplicated. All pages of each bounded ClinicalTrials.gov query were downloaded, and named records plus selected relevant new/changed protocols were appraised. This is focused partial review, not a worldwide full literature/regulator/safety census; successful full-topic dates must remain unchanged.; Bounded query retrieved 136 records across 2 pages; incidental studies excluded. Named topic records refreshed: 5. Full older evidence, international registries, comprehensive harms and all original conference/podcast recordings remain gaps.; New condition-specific baseline remains incomplete. Selected inherited older pivotal sources and newly recovered formal programs were reviewed, without declaring the preceding 90-day/older trial corpus complete.

**Informal-source coverage:** Original ENLIGHTEN-6 anonymous fragmented-sleep account is saved once in GLP-1 with cross-link; no incidence inference. Exact-date insomnia Reddit searches produced irrelevant pregnancy/old matches and no distinct formal-development rumor selected. Insomnia podcast/talk full recordings and broader informal safety census remain incomplete.

[Full coverage record](../updates/2026-10-13_scheduled_research_update.md).


### Focused update — 2026-10-09

<span class="note-anchor" id="note-2026-09-16-smart-insomnia-baseline"></span>

#### Large pragmatic trial compares commonly used insomnia medicines

**Baseline context recovered October 9 — SMART, NCT07542756.** University of Pennsylvania/PCORI plans **1,200 adults with chronic insomnia** in a double-blind sequential multiple-assignment randomized trial. The registry reports **recruiting**, actual start **May 1, 2026**, and last update **September 16**; a mirror's later synchronization date is not a new recruitment event.

Arms include doxepin **3/6 mg**, zolpidem **5/10 mg**, trazodone **50/100 mg**, immediate-release melatonin **3/5 mg**, diphenhydramine **25/50 mg**, and placebo. Participants aged 64+ are excluded from the diphenhydramine arm. All receive sleep-hygiene education.

At one month, primary outcomes include **ISI response of at least eight points**, side-effect frequency/severity, and **FOSQ-10 daytime function**; responders are followed for durability/harms through six months. No results are posted. This trial does not endorse every studied medicine or erase off-label/guideline distinctions; symptoms and function are separate from sleep architecture. Estimated primary/final completion is **January 1, 2032**, not a guaranteed publication date.

**Sources:** [Primary source 1](https://clinicaltrials.gov/study/NCT07542756).

**Remaining gaps:** New condition baseline remains incomplete. Reviewed inherited hub, preceding 90-day development leads and selected older pivotal/contextual sources; October 6 findings deduplicated.; 93 named NCT records across the ten topics and ten discovery queries downloaded successfully through the ClinicalTrials.gov public API. Download is not a claim that all fields/safety/results were exhaustively appraised.; Focused review only. Do not advance full successful-check timestamps or label incomplete remaining searches as no news.; Broad insomnia discovery returned 673 records, first 100 downloaded; selected relevant records screened; much incidental oncology/psychiatry symptom language remains. Older drug label, CBT-I/digital durability and sleep-architecture safety census incomplete. Prior DARI-DREAM and COMISA-PEC not re-reported.

**Informal-source coverage:** Oct8 SOLIS-1 participant self-report and Oct2 Eloralintide weekly-trial posts contain insomnia/fatigue anecdotes; no population safety estimates or independent insomnia-drug milestone inferred. Original insomnia podcast/talk transcripts incomplete.

[Full coverage record](../updates/2026-10-09_scheduled_research_update.md).


### Focused update — 2026-10-06

<span class="note-anchor" id="note-2026-09-28-daridream"></span>

#### DARI-DREAM registration resolves the missing daytime-function study identifier

**Source/event date: September 28, 2026. Evidence: new trial registration recovered October 6.** DARI-DREAM / ID-078A306 supplies the missing daridorexant daytime-functioning study identifier. It plans 344 adults/older adults with insomnia, randomized 1:1 to daridorexant 50 mg or placebo for approximately three months, with triple masking and ten-day safety follow-up. Primary: subjective total sleep time at month 3. IDSIQ sleepiness and total daytime-impairment scores are secondary; home EEG is used to verify entry criteria.

NOT_YET_RECRUITING. September 2026 start remains estimated; November 2027 primary and December 2027 final completion are registry estimates. No results or trial safety estimates are posted. This closes registration uncertainty but does not verify the July forecast actual start or a new U.S. daytime-function claim. Adult insomnia approval is separate from this label-enabling research.

[Source 1](https://clinicaltrials.gov/api/v2/studies/NCT07843329) · [Source 2](https://clinicaltrials.gov/study/NCT07843329)

<span class="note-anchor" id="note-2026-10-05-comisapec"></span>

#### COMISA-PEC begins studying daridorexant before CPAP

**Source date: October 5, 2026; actual start: September 30. Evidence: registry recruitment update.** COMISA-PEC plans 150 French adults with AHI≥15 and ISI≥15, newly diagnosed and previously untreated with PAP/daridorexant. The open-label single-group strategy starts daridorexant before CPAP; the primary measure is nightly PAP use at four months, with 12-month use and daytime IDSIQ scores secondary. RECRUITING; estimated primary completion September 2028 and final September 2029. No efficacy/safety results. The outcome wording references untreated comparators, although the registered allocation is single-group; causal comparison and comparator selection need protocol clarification. This is not a randomized demonstration that medication improves adherence or treats airway obstruction, and creates no new U.S. indication.

[Source 1](https://clinicaltrials.gov/api/v2/studies/NCT07743931) · [Source 2](https://clinicaltrials.gov/study/NCT07743931)

<span class="note-anchor" id="note-2026-08-18-sleepymed"></span>

#### Small digital CBT-I versus zolpidem trial is older baseline context

**Historical baseline addition: online publication August 18, 2026; December issue date is not publication date.** jRCT2032230353 randomized 24 Japanese adults with persistent sleep-onset insomnia after sleep education to five weeks of unguided “IIIP MED: Sleepy Med” or zolpidem, followed for five more weeks. Subjective sleep-onset latency changed −20.65 minutes (95% CI −32.05 to −9.65; n11) versus −22.42 (−29.37 to −15.46; n13) at week 5; between-group P=.7729. Week-10 improvement persisted in nine digital participants, but the between-group comparison was also nonsignificant. No treatment-related AE was reported with the app; one zolpidem participant reported somnolence.

The tiny exploratory trial was underpowered: nonsignificance does not establish equivalence/noninferiority, remission or broad daytime benefit. A developer holds copyright on the app. No U.S. clearance was verified. Next confirmatory study/date is unannounced.

[Source 1](https://pubmed.ncbi.nlm.nih.gov/42623797/) · [Source 2](https://doi.org/10.1016/j.sleep.2026.109222)

**Coverage:** 2026-10-06: daridorexant daytime-function study October2026; direct named-drug registry search (30latest); 2026-10-06: insomnia digital CBT trial SeptemberOctober2026, PubMed42623797; 2026-10-06: Reddit DARIDREAM/insomnia trial leads

**Remaining gaps:** Pending condition baseline partially refreshed across preceding90days, new DARI-DREAM protocol, COMISA and older digital pilot. Existing ten-drug baseline and digital meta-analysis retained; no completed comprehensive baseline.; Full DARI-DREAM protocol/daytime-label intent and actual dosing remain unverified; full digital-pilot text blocked, PubMed XML read. Device/new-drug/digital worldwide census and original podcast sweep incomplete.

**Informal-source coverage:** No noteworthy attributable DARI-DREAM leak found; personal medication/CBTi discussion is not trial efficacy. Podcast recordings and all trial-participant threads incomplete.

[Full coverage record](../updates/2026-10-06_scheduled_research_update.md).


### CBT-I and validated digital therapy

**Development / U.S. status:** CBT-I has a strong AASM recommendation. Prescription Sleepio was cleared under K233577 on August 5, 2024, as an adjunct to usual care for chronic insomnia in adults; this does not validate every consumer app.

**Evidence / limitations:** The 336-person CrEDIT randomized trial had a 10-week primary assessment and follow-up through 24 weeks. The September 28, 2026 network meta-analysis included 96 randomized trials and found a 4.24-point ISI reduction with digital CBT versus pooled controls (95% CI 3.65–4.83 lower; moderate certainty). Direct comparisons and many study-quality assessments limit stronger rankings. [AASM guideline](https://pmc.ncbi.nlm.nih.gov/articles/PMC7853203/) · [FDA clearance](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233577.pdf) · [Evidence synthesis](https://doi.org/10.1186/s12916-026-05129-8)

**Next milestone:** Comparative delivery, durable remission/function and access; no firm readout date verified. [Original detailed coverage](12_sleep.md#digital-cbt-for-insomnia-retains-the-clearest-support-in-a-large-evidence-synthesis).

### Established insomnia medicines

**Development / U.S. status:** The selected baseline distinguishes approved formulations of doxepin, ramelteon, daridorexant, lemborexant, suvorexant, zolpidem, eszopiclone, zaleplon, temazepam and triazolam from off-label trazodone and mirtazapine. Approval and guideline recommendation are separate.

**Evidence / limitations:** Low-dose doxepin addresses maintenance, ramelteon addresses onset, and some other medicines have evidence for both. Historical controlled trials, formulation-specific labels, dependence/withdrawal, next-day impairment and serious class warnings remain in the [full medication baseline](12_sleep.md#sleep-insomnia-baseline). The baseline review date is October 3; it is not a complete surveillance check.

**Next milestone:** Meaningful comparative and longer-term results; no common next date verified. [AASM pharmacologic guideline](https://aasm.org/wp-content/uploads/2017/07/PharmacologicTreatmentofInsomnia.pdf) · [VA/DoD 2025 guideline](https://healthquality.va.gov/HEALTHQUALITY/guidelines/CD/insomnia/I-OSA-CPG_2025-Guideline_final_20250915.pdf)

### Investigational and non-U.S. programs

**Daridorexant pediatric / daytime-function studies:** Pediatric phase 2 NCT05423717 has a March 30 sponsor topline, not a pediatric approval or established durable safety result. The July 30 forecast daytime-functioning study was not matched to a verified start/registration in the earlier checks. [Full program details](12_sleep.md#expanded-sleep-therapy-baseline-september-12-2026).

**Vornorexant / Vorzzz:** Japanese approval and a published 52-week randomized-dose, open-label study do not establish U.S. approval or placebo-adjusted long-term benefit. No firm next U.S. milestone verified. [Full findings and safety](12_sleep.md#vornorexant-long-term-insomnia-study-published) · [Primary publication](https://pubmed.ncbi.nlm.nih.gov/42731338/).

**Neuro-DORA / lemborexant:** NCT06823752 measures short-term neurodegeneration biomarkers, not dementia prevention or long-term cognitive outcomes. Registry-estimated completion December 2027 is not a publication promise. [Full notes](12_sleep.md#neuro-dora-studies-sleep-treatment-and-neurodegeneration-biomarkers) · [Registry](https://clinicaltrials.gov/study/NCT06823752).

## Dated history

### October 3, 2026 — Topic organization

Created this condition-specific entry from existing sleep coverage. Earlier sources, program dates, historical findings and successful research-check timestamps were preserved. See the [organization record](../updates/2026-10-03_sleep_category_organization.md) and [original history](12_sleep.md#dated-history). This is a navigation and baseline projection, not a new medical-news event.