Melatonin: where the agencies disagree
This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.
What the record shows
AWMSG (Wales) and CHUIKYO (Japan) recommended or restricted melatonin, while CIPM (Spain) and SMC (Scotland) did not recommend it.
TLV (Sweden) has been harder on melatonin than on its own caseload: it refused 4 of 11 decisive submissions here (36%), against a base rate of 16% across everything it has assessed.
The file has been open for more than a decade: 17.9 years separate the first record, 4 Jun 2008 at AWMSG (Wales), from the most recent, 20 May 2026 at CIPM (Spain).
TLV (Sweden) changed its position: not recommended on 16 Dec 2013, restricted by 30 Jan 2023, after a resubmission.
No assessment is on file from G-BA (Germany), which is among the eight highest-volume agencies here.
Not every gap is a refusal: for melatonin, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 12 of 35 records date from 2023 or later.
7 distinct indication wordings are recorded for melatonin by the agencies that label one in English (AWMSG, PBAC and SMC).
4 of these 35 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
AWMSG (Wales) was first to assess melatonin, on 4 Jun 2008; PBAC (Australia) did not open a file until 2021 — an unusually long tail of 13.1 years between the earliest and latest system to look at it.
The record arrives in waves: 9 separate years each carry two or more decisions, spread across 11 years in total.
7 of the 8 agencies here assessed melatonin more than once, TLV (Sweden) most often at 11 entries — repeat review is the norm for this molecule rather than the exception.
8 of the 18 agencies in this archive hold a record for melatonin.
The full ledger for melatonin reads 13 not recommended, 13 recommended, 5 restricted and 2 deferred, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 6 May 2026 | Listing (Transparency Committee) | SMR low · ASMR V | source |
| CIPM (Spain) | 25 Feb 2026 | Indicación terapéutica autorizada: Tratamiento del insomnio en niños y adolescentes de 2 a 18 años de edad con trastorno… | not financed by the SNS · art. 92 d, e | source |
| SMC (Scotland) | 10 Nov 2025 | Treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient… | not recommended | source |
| PBAC (Australia) | 2023 | Smith-Magenis syndrome | The PBAC deferred this item. It will be considered at the December 2023 PBAC intracycle me… | source |
| TLV (Sweden) | 30 Jan 2023 | Melatonin Evolan oral lösning ingår i högkostnadsskyddet med begränsning | restricted subsidy | source |
30 further decisions for melatonin, across 8 agencies, are not shown here. They include the most recent record on file, 20 May 2026 from CIPM (Spain); its outcome is in the subscriber dataset. They link to 24 further source documents.
Related molecules
- midazolam — same ATC class N05C — Psycholeptics
- dexmedetomidine — same ATC class N05C — Psycholeptics
- daridorexant — same ATC class N05C — Psycholeptics
- remimazolam — same ATC class N05C — Psycholeptics
- zolpidem — same ATC class N05C — Psycholeptics
- vutrisiran — also decided by CIPM in 2026Q2
Coverage: 35 decisions for melatonin from 8 agencies, 2008 to 2026. Data to 7 Sep 2026. ATC class N05C — Psycholeptics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.