# Sleep therapies scope expansion — September 12, 2026

[Home](../README.md) · [Sleep therapies](../topics/12_sleep.md) · [Research log](README.md)

## Scope decision

The sleep research category was expanded. An active sleep topic already existed, so its scope and title were expanded to **Sleep therapies and sleep disorders**, keeping stable ID `sleep`, path `topics/12_sleep.md`, and the 25-topic total.

Explicit coverage: insomnia medicines, CBT-I and validated digital therapeutics; circadian-rhythm treatments; narcolepsy and idiopathic hypersomnia; restless legs; apnea medicines/devices and clinically useful detection. Drugs, behavioral treatments and devices remain distinct. Sleep measurements are separated from remission, daytime function, durability and harms.

## Selective baseline and findings

- Added SleepioRx/digital CBT-I and the AASM behavioral-treatment guideline as established-care context.
- Added daridorexant adult approval and sponsor-reported pediatric Phase 2 development; actual start/registration of a forecast daytime-functioning study remains unverified.
- Added a small delayed sleep-wake phase treatment trial, with its active-comparator and sample-size limits.
- Added tasimelteon indication-specific labeling and the contested jet-lag application hearing; the elapsed prehearing date is not proof of completion.
- Added FDA-authorized Nidra/NTX100 and RESTFUL/extension evidence for refractory restless legs, distinguishing short blinded results from open-label follow-up.
- Verified that the live Orzeyful brand page forecasts availability by November 2026, pending DEA scheduling. This is an undated live sponsor statement observed during this check; actual launch is not established.

Historical clearances, approvals and publications are baseline context, not new September 2026 news.

## Coverage and gaps

**Sleep:** targeted scope expansion and selective primary-source review only. The earlier apnea/narcolepsy baseline was preserved; this pass did not repeat the entire category search or complete informal-source/rumor coverage. No new rumor is asserted, and no inference of absence is made. Retry unresolved daridorexant start/registration, tasimelteon hearing status, Orzeyful scheduling/launch and broader orexin milestones in the next scheduled run.

**Other active topics:** no research performed in this scope update; their notes, event records and successful-check timestamps remain unchanged: whole_body_mri, galleri, glp1, muscle, longevity, localized_fat, cardiovascular, alzheimers, psychedelics, ssri_antidepressants, cancer_vaccines, autoimmune, liver, kidney, joint_preservation, pain, hearing_vision, hair_loss, skin_aging, facial_volume, scars, pigmentation, acne_rosacea, dental.

## Integration and validation

Updated topic title and scope, catalog, watchlist, tag index, home preview, current landscape, milestone calendar, latest-library update and log index. The saved automation was updated through the scheduled-task tool and read back: same active Tuesday/Friday 9 a.m. Eastern schedule, original task, website workflow and meaningful-change notification policy.

The original topic notes, historical logs, initial brief and previously seen events were retained. Global research-run and all existing full-topic successful-check timestamps remain unchanged. Scope-expansion metadata and distinct baseline/live-forecast records are stored after notebook readback. The concurrently active Therapy Atlas site task owns the final export, validation and private publication; publication success is verified there before claiming the site is current.

## Sources checked

- https://pmc.ncbi.nlm.nih.gov/articles/PMC7853203/
- https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233577.pdf
- https://www.bighealth.com/faqs
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef
- https://www.idorsia.com/investors/news-and-events/media-releases/media-release-details?id=3653864
- https://www.idorsia.com/media/news/news-archive/media-release-details?id=3733312
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11217625/
- https://clinicaltrials.gov/study/NCT03715465
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205677Orig1s013lbl.pdf
- https://www.govinfo.gov/content/pkg/FR-2026-06-03/pdf/2026-11046.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220059
- https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN220059.pdf
- https://pubmed.ncbi.nlm.nih.gov/37458698/
- https://pubmed.ncbi.nlm.nih.gov/37439365/
- https://www.orzeyful.com/