Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Zolpidem
Also marketed in the EU under the name(s): Adorma, APO-ZOLPIDEM, Apo-Zolpin, Bikalm, Cymerion, DALPARAN, Dodorest, Edluar, Hypnogen, HYPNOGEN, HYPNONORM, Insom, Ivadal, KALINICTA, Lunata, Mondeal, Nasen, NOTTEM, Noxizol, Nytamel, Onirex, ONIRIA, OPSYCON, Perluna, PIDEZOL, Polsen, Sanval, SOMNOGEN, Somnor, Sonirem, Stella, Stilnoct, Stilnox, Xentic, ZADOBRA, Zoldem, ZOLEP, Zolnod, Zolpeduar, Zolpi-Lich, Zolpi-Q, Zolpic, Zolpidem 1A-Pharma, Zolpidem Actavis, Zolpidem AL, ZOLPIDEM ALMUS, ZOLPIDEM ALTER, ZOLPIDEM APOTEX, Zolpidem Aristo, ZOLPIDEM ARROW, ZOLPIDEM ATB, Zolpidem Aurobindo, ZOLPIDEM BAYER, ZOLPIDEM BEXAL, ZOLPIDEM BEXALABS, ZOLPIDEM BIOGARAN, Zolpidem Cinfa, ZOLPIDEM CRISTERS, Zolpidem CT, ZOLPIDEM CTRS, ZOLPIDEM DESGEN, ZOLPIDEM DOC GENERICI, Zolpidem dura, ZOLPIDEM EDIGEN, Zolpidem EG, Zolpidem Eurogenerics, ZOLPIDEM FARMALIDER, Zolpidem G.L., Zolpidem Generis, Zolpidem Genthion, Zolpidem Genthon, ZOLPIDEM GNR, Zolpidem Heumann, Zolpidem Hexal, Zolpidem IPCA, ZOLPIDEM KIRION, Zolpidem Labesfal, Zolpidem LYFIS, Zolpidem Mylan, Zolpidem neuraxpharm, ZOLPIDEM NORMON, Zolpidem Orifarm, Zolpidem Orion, Zolpidem Pfizer, ZOLPIDEM PHARMAGENUS, Zolpidem Ranbaxy, Zolpidem Ratiopharm, Zolpidem real, ZOLPIDEM RPG, Zolpidem Sandoz, Zolpidem Sanofi-Aventis Belgium, Zolpidem STADA, Zolpidem TAD, Zolpidem Tartrate, Zolpidem Teva, ZOLPIDEM TEVAGEN, Zolpidem Vitabalans, Zolpidem Wynn, ZOLPIDEM ZYDUS, Zolpidemtartaat Actavis, Zolpidemtartraat, Zolpidemtartraat ADOH, Zolpidemtartraat Apotex, Zolpidemtartraat CF, Zolpidemtartraat Mylan, Zolpidemtartraat PCH, Zolpidemtartraat ratiopharm, Zolpidemtartraat ratiopharm, Zolpidemtartraat Sandoz, Zolpidemtartraat Stada, ZolpiGen, Zolpinox, Zolpitop, ZOLPREM, Zolsana, Zonadin, Zonoct
Active substance: zolpidem
Indication: Zolpidem is a hypnotic agent with the indication of short-term treatment of insomnia in the situations where insomnia is debilitating or is causing severe distress for the patient.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/06/2014 Referral EMEA/H/A-31/1377 (2014)4351 of 23/06/2014