Circadian rhythm disorders

Source date: 2026-10-28. Recorded in this review: November 6, 2026.

Evidence: Recovered sponsor-reported regulatory hearing schedule.

What changed: Vanda’s October 28 SEC-filed release says the formal FDA administrative hearing concerning tasimelteon/Hetlioz for jet-lag disorder is expectedDecember 14–18,2026. A separate legal challenge concerning insomnia was awaiting a court decision afterSeptember oral argument.

Limitations: This is a recovered sponsor legal/regulatory schedule, not an approval, improved clinical result or announced court/FDA decision date. Jet lag, DSWPD, Non-24 and insomnia remain distinct indications.

Safety: No new efficacy/harms tables.

U.S. status: Existing Hetlioz indications remain separate; no jet-lag or generalized-insomnia approval follows from scheduling a hearing.

Next milestones: Hetlioz jet-lag administrative hearing: 2026-12-14/2026-12-18 (Sponsor-reported scheduled hearing)

Sources: Primary source.

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 preceding90day/older condition baseline and sustained phase/function evidence remain incomplete. Jet-lag hearing schedule is not approval; court outcome unavailable.

Informal-source coverage: Tasimelteon/Non24/DSPD/shift-work informal-source searches sampled; patient timing experiences do not establish controlled efficacy. Original talk/audio coverage incomplete.

Full coverage record.

Source date: 2026-10-20. Recorded in this review: October 27, 2026.

Penn State/NIA's SmartEnLite / NCT07883291 plans 300 nursing-home residents aged 55+ with dementia and agitation, depression and/or apathy. The randomized crossover compares four weeks of automatic bright daytime/dim nighttime lighting with usual lighting during a 13-week participation period.

Primary measures include agitation, depression, apathy, behavioral symptoms, mood, wearable-derived sleep timing/duration/quality and rest–activity rhythm stability, plus lighting-related adverse effects. These wearable estimates are not PSG REM/deep-sleep measurements, and this is not a disease-modifying dementia or prevention trial.

The record, first public October 20, is not yet recruiting; estimated start is December 1, 2026, with primary/final completion February 2031. It closes an unappraised protocol lead from the previous run rather than representing new clinical results.

U.S. status: Behavioral/environmental device research; no new therapy clearance or disease-modifying indication.

Next milestones: SmartEnLite estimated start: 2026-12-01 (Registry estimate); SmartEnLite primary completion: 2031-02 (Registry estimate).

Sources: primary source.

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.; SmartEnLite protocol now appraised; wearable sleep/rhythm metrics do not establish PSG architecture or dementia disease modification.; Other shift-work, DSPD/Non24 treatment/harm and global registry coverage remains incomplete; no new result inferred from registry timing.

Informal-source coverage: Sampled original DSPD/Non24/shift-work Reddit discussions and interview/talk leads. Patient burden reports are not controlled evidence; no new appraised clinical/program rumor selected.

Full coverage record.

September 29 sponsor release, recovered October 16 — NCT04652882. Vanda reports that adults with delayed sleep-wake phase disorder receiving tasimelteon 20 mg daily for 28 days advanced diary-recorded sleep onset 42.5 minutes, versus 5.4 minutes with placebo: a 37.1-minute difference, p=.022.

The release reports 43 enrolled, but the numerical table covers 20 active and 20 placebo; the remaining three and missing-data handling are unexplained. Confidence intervals are absent. An exploratory ≥30-minute response occurred in 12/20 versus 3/20 (p=.008).

The sponsor says no new safety signals, without adverse-event counts, discontinuations or detailed harms. Small size and short follow-up limit safety and durability. Earlier sleep timing is not proof of normalized circadian biomarkers, better sleep architecture or sustained daytime function.

This closes a saved search gap: the registry still has no posted results, but sponsor topline results do exist. Vanda plans an FDA discussion/supplemental application, with no verified filing or decision date. HETLIOZ’s existing U.S. Non-24/Smith-Magenis uses do not approve DSWPD.

Sources: PR Newswire · news release; ClinicalTrials.gov · NCT04652882.

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 345 records across 4 pages of the bounded ClinicalTrials.gov query, plus 4 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.; Recovered September 29 tasimelteon sponsor topline closes a specific saved publication-access gap. Actual September completion and no registry results remain valid statements; saying no topline exists is no longer accurate. SUSTAIN and ICU studies refreshed without new results. Jet-lag hearing outcome, sustained phase/function evidence and full older baseline remain incomplete.

Informal-source coverage: Original Non-24/DSPD discussions include disability/access burden and personal timing responses, not new controlled efficacy or regulatory evidence. September tasimelteon topline was verified at the sponsor release rather than inferred from Reddit. Jet-lag hearing speculation remains unconfirmed; full audio incomplete.

Full coverage record.

Status reconciliation, checked October 13 — NCT04652882. Vanda's randomized masked Phase 3 tasimelteon-versus-placebo trial in delayed sleep-wake phase disorder now lists completed, 43 actual participants, with September 4, 2026 actual primary/final completion. The October 9 update was already retrievable at the prior run but not reconciled into the topic's elapsed-estimate description; this is a coverage correction, not newly released results.

Primary is diary-measured change in sleep-onset over 28 days. No results are posted; completion does not prove improved circadian phase, daytime function or generalized insomnia benefit. Existing tasimelteon indications do not establish U.S. approval for DSWPD. A separate jet-lag hearing remains unresolved. Next: primary outcomes/harms and any sponsor readout; no date announced.

Sources: ClinicalTrials.gov · NCT04652882.

NCT07869901, first posted October 13. A recruiting nonrandomized unmasked 70-person ICU study compares a multicomponent sleep/circadian package with usual care: reduced nighttime light/noise/care disruptions, daytime light/mobility and orientation.

Primary outcomes through day 3 are recruitment, retention, data completeness and adherence. Secondary measures include timed melatonin/cortisol, subjective sleep, actigraphy and night 2 polysomnographic total sleep, N3 and REM percentages. These are useful architecture/phase measures, but their improvement would not independently prove recovery, remission of a circadian disorder or better survival. Nonrandom allocation and the combined package limit causal/component interpretation.

Actual start August 1, 2026; estimated primary completion June 30, 2027, final December 31, 2027. No results or harms rates. This is hospital research, not a U.S. approved device/drug or an established at-home protocol.

Sources: ClinicalTrials.gov · NCT07869901.

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 161 records across 2 pages; incidental studies excluded. Named topic records refreshed: 3. 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: Targeted original DSPD, Non-24 and shift-work informal searches did not yield a distinct sourced development signal selected for inclusion. Some exact-date searches failed to return relevant posts. Full talks/audio, the jet-lag hearing outcome and disorder-specific patient-experience coverage remain incomplete.

Full coverage record.

Historical baseline addition reviewed October 6, 2026. NCT04652882 is a randomized quadruple-masked placebo-controlled phase 3 tasimelteon study in delayed sleep-wake phase disorder, 70 planned adults. Primary endpoint: sleep-diary onset change over 28 days. ACTIVE_NOT_RECRUITING in the July 27 record; actual start December 9, 2020. September 2026 primary/final completion is still an estimate after that month elapsed, with no posted results. Existing Non-24/Smith-Magenis indications do not establish DSWPD, general insomnia or jet-lag approval. This is an older program newly added to the condition page; sustained phase alignment/daytime function and safety remain pending.

ClinicalTrials.gov · NCT04652882 · ClinicalTrials.gov · NCT04652882

Historical baseline addition reviewed October 6, 2026. SUSTAIN plans 520 adults with excessive sleepiness associated with shift-work disorder, randomized double-blind to two solriamfetol regimens or placebo for 12 weeks. Coprimary outcomes are MWT sleep latency and clinician-rated sleepiness severity during night shifts. RECRUITING in the July24 record, actual start August1,2024; primary/final completion is estimated December2026. No results posted. This measures alertness during shift work, not proven correction of circadian phase. Existing solriamfetol indications do not establish a shift-work approval. Safety, blood-pressure/heart-rate effects and longer-term real-work performance need result/label appraisal.

ClinicalTrials.gov · NCT06568367 · ClinicalTrials.gov · NCT06568367