Brief · Use case · Innovation
Insomnia DTx Comparison.
LiveComparisonCompare FDA-cleared software treatments for insomnia on status, population, endpoint, effect size, duration, prescription and reimbursement.
Insomnia DTx Comparison is a ready-made use case for Innovation. It ships under the Comparison template.
For digital health and market access leads. You get the products and criteria stated first, one sourced table, where the products differ and where their endpoints are not comparable. Cells are cited to FDA records, labeling or payers, or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
How do Somryst, SleepioRx and one other FDA-cleared software treatment for insomnia compare on regulatory status, population, primary endpoint and effect size, duration of use, prescription requirement and reimbursement?
What is compared
The comparison starts from FDA’s own records, so regulatory status is a fact with a date and a number, and the rest is read against the labeling.
| Item | What it is | Where its cells come from |
|---|---|---|
| Somryst | Cleared by FDA on 23 March 2020 under 510(k) K191716 for Pear Therapeutics, product code QVO, regulation 882.5801.1 | The FDA 510(k) record and the cleared labeling. The product’s current owner and availability must be checked before any client use. |
| SleepioRx | FDA’s 510(k) record K233577 lists the device as Sleepio for Big Health, with a decision of substantially equivalent on 5 August 2024, product code QVO and regulation 882.5801. The link between that record and the name SleepioRx rests on the matching applicant and product code and on the company’s announcement.2 | The FDA 510(k) record and the company’s labeling. Confirm the name against the labeling. |
| A third software treatment | The comparison picks one only from the same product code and says why.1,2 | The FDA 510(k) database for product code QVO. |
What the comparison does
Regulatory status as a fact. Both records carry the same product code and regulation number, so the products are cleared as the same type of device. The comparison shows each record’s number, date and decision, and does not infer anything the record does not say.1,2
Endpoints that cannot be lined up. Different products measure insomnia with different instruments and over different periods. The comparison puts each primary endpoint and effect size in its own cell with its source, and the caveats say where the values are not comparable.
Prescription and reimbursement. The requirement to prescribe and the payer position are read from labeling and payer documents. Where a payer position is not public, the cell is a gap.
Recommended length
Standard
Three products on six criteria fit one table. Standard adds where the difference matters and a chart in about 1,200 words.
You can pick another length on the form. The other two stay available.
Assumptions the comparison checks
The comparison states the assumptions that make the cells comparable and says where they fail. Examples for this subject:
- The product name in the cleared labeling matches the name on the FDA record.
- The product is still on the market under its current owner.
- The studies behind each product used instruments that can be read side by side.
Standards, guidance and sources
FDA records
The decision practice behind the memo itself is on the template page.
What gets flagged
Any cell without a source, any effect size measured on a different instrument or period, any reimbursement position that is not public, and the link between a record and a product name.
What arrives
- What is compared, and on what criteria
- The comparison
- Where the difference matters
- Where they do not differ
- Caveats on comparability
What it will not do
It does not recommend an item. A comparison shows how the items differ and where they do not; if you need a recommendation, run a Decision Memo on the same items.
It does not assess clinical quality beyond what the sources report, and it does not say which product a clinician should prescribe.
It does not recommend an item. A comparison shows differences; a Decision Memo recommends.
It does not handle more than five items. Beyond five, the table stops being readable and a Landscape or a Scan is the better template.
It does not invent a cell. A cell without a source is a gap, and the caveats say how many there are.
References
- [1] U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020. Read on 9 October 2026: name, applicant, date, product code, regulation number and decision. The indications summary was not read.
- [2] U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024. Read on 9 October 2026. The record names the device Sleepio; the tie to SleepioRx comes from the company’s announcement and the matching applicant and product code.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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