Belgium· BE-AMP-SAM666418-00
Stilnoct 10 mg
A medicinal product containing zolpidem hemitartrate, registered in Belgium by PI Pharma.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Zolpidem Hemitartrate
- Manufacturer
- PI Pharma
- Country
- Belgium (BE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zolpidem hemitartrate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADORMAAlkaloid - INT d.o.o., Ljubljana - Črnuče
- PolandApo-ZolpinInPharm Sp. z o.o.
- United StatesAmbienCosette Pharmaceuticals, Inc.
- SpainDALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULASanofi Aventis S.A.
- FinlandEanoxDesitin Arzneimittel GmbH
- FranceSTILNOX 10 mg, comprimé pelliculé sécableSANOFI WINTHROP INDUSTRIE
- NetherlandsZolpidemtartraat 10 mg, filmomhulde tablettenSynthon B.V.
- SwedenStilnoct 10 mg Filmdragerad tablettSanofi AB
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Ivadal, Mondeal
- Bulgaria · Адорма, Золcaна
- Cyprus · Stilnox
- Czechia · Adorma, Hypnogen
- Germany · Bikalm, Stilnox
- Denmark · Stilnoct, Zolpidem Actavis
- Estonia · Hypnogen, Stilnox
- Spain · Dagan, Dalparan
- Finland · Somnor, Stella
- France · Oratika, Stilnox
- United Kingdom (Northern Ireland) · Zalzo, Zolpidem
- Greece · Hypnonorm, Oniria
- Croatia · Lunata, Sanval
- Hungary · Hypnogen, Sanval
- Ireland · Nytamel, Stilnoct
- Iceland · Edluar, Stilnoct
- Italy · Belirem, Nottem
- Lithuania · Hypnogen, Stilnox
- Luxembourg · Stilnoct, Zolpeduar
- Latvia · Hypnogen, Stilnox
- Malta · Stilnox, Zolpidem Aurobindo
- Netherlands · Zolpidem Tartrate Ratiopharm, Zolpidemtartraat Aurobindo
- Norway · Stilnoct, Zolpidem Actavis
- Poland · Apozolpin, Hypnogen
- Portugal · Stilnox, Zolpidem Aurovitas
- Romania · Stilnox, Zadobra
- Sweden · Edluar, Stilnoct
- Slovenia · Perluna, Sanval
- Slovakia · Hypnogen, Sanval
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FAMHP / AFMPS (Belgium). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/e61d4456-c329-4508-b39c-503982654c43 GET /v1/drugs/e61d4456-c329-4508-b39c-503982654c43?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Film-coated tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Stilnoct 10 mg",
"name_fr": "Stilnoct 10 mg",
"name_nl": "Stilnoct 10 mg",
"amp_code": "SAM666418-00",
"strengths": [
"10.0000"
],
"pack_count": 4,
"substances": [
"Zolpidem Hemitartrate",
"Lactose",
"Sodium Starch Glycolate (Type A)"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": [
"1637PI0793F003"
]
}See everything about zolpidem hemitartrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.