Active substance
Zolpidem
- SFDA 4
- US FDA 43
- Health Canada 12
- US price lines 10
- NHS prices 2
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ZOLONIA 10 mg Film Coated Tablet | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 36.85 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ZOLONIA 5 mg Film Coated Tablet | 5 mg | Film-coated tablet · Oral use | 28 Blister | SAR 18.40 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ZOLPIGEN | 10 mg | Film-coated tablet · Oral use | 20 Blister | SAR 27.70 | Generic · Prescription | RIYADH PHARMA | Valid |
| STILNOX 10MG F-C TABS | 10 mg | Film-coated tablet · Oral use | 20 Blister | SAR 27.70 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ALZHEIMER / DEMENTIA; INSOMNIA; JET LAG - INSOMNIA; SCHIZOPHRENIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AMBIEN | 5MG; 10MG | tablet · oral | COSETTE | Prescription | 16 Dec 1992 |
| AMBIEN CR | 12.5MG; 6.25MG | tablet, extended release · oral | COSETTE | Prescription | 2 Sep 2005 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | PHARMAZONE | Prescription | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | SANDOZ | Prescription | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | AUROBINDO PHARMA | Prescription | 4 May 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | TORRENT PHARMS | Prescription | 17 Aug 2007 |
| EDLUAR | 5MG; 10MG | tablet · sublingual | VIATRIS | Prescription | 13 Mar 2009 |
| ZOLPIDEM TARTRATE | 6.25MG; 12.5MG | tablet, extended release · oral | SANDOZ | Prescription | 1 Jul 2011 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | CHARTWELL MOLECULAR | Prescription | 30 Jul 2012 |
| ZOLPIDEM TARTRATE | 6.25MG; 12.5MG | tablet, extended release · oral | LUPIN | Prescription | 11 Sep 2013 |
| ZOLPIDEM TARTRATE | 1.75MG; 3.5MG | tablet · sublingual | NOVEL LABS INC | Prescription | 3 Jun 2015 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · sublingual | PH HEALTH | Prescription | 1 Aug 2016 |
| ZOLPIDEM TARTRATE | 1.75MG; 3.5MG | tablet · sublingual | DR REDDYS | Prescription | 18 Nov 2016 |
| ZOLPIDEM TARTRATE | 6.25MG; 12.5MG | tablet, extended release · oral | SUN PHARM | Prescription | 24 Jan 2017 |
| ZOLPIDEM TARTRATE | 1.75MG; 3.5MG | tablet · sublingual | PH HEALTH | Prescription | 11 Sep 2017 |
| ZOLPIDEM TARTRATE | 6.25MG; 12.5MG | tablet, extended release · oral | BRECKENRIDGE | Prescription | 4 Jun 2020 |
| ZOLPIDEM TARTRATE | 7.5MG | capsule · oral | ALMATICA | Prescription | 9 May 2023 |
| ZOLPIDEM TARTRATE | 7.5MG | capsule · oral | UMEDICA LABS PVT | Prescription | 12 May 2026 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | STRIDES PHARMA | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | TEVA | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | RISING | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | WATSON LABS | Discontinued | 23 Apr 2007 |
| ZOLPIDEM TARTRATE | 5MG; 10MG | tablet · oral | APOTEX INC | Discontinued | 23 Apr 2007 |
18 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-ZOLPIDEM ODT | 02434946 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | APOTEX INC |
| APO-ZOLPIDEM ODT | 02436159 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | APOTEX INC |
| JAMP ZOLPIDEM ODT | 02540592 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | JAMP PHARMA CORPORATION |
| JAMP ZOLPIDEM ODT | 02540606 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | JAMP PHARMA CORPORATION |
| MINT-ZOLPIDEM ODT | 02472821 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | MINT PHARMACEUTICALS INC |
| MINT-ZOLPIDEM ODT | 02472848 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | MINT PHARMACEUTICALS INC |
| PMS-ZOLPIDEM ODT | 02436175 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | PHARMASCIENCE INC |
| PMS-ZOLPIDEM ODT | 02436183 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | PHARMASCIENCE INC |
| PRO-ZOLPIDEM ODT | 02537346 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | PRO DOC LIMITEE |
| PRO-ZOLPIDEM ODT | 02537354 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | PRO DOC LIMITEE |
| SUBLINOX | 02370433 | 10 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | BAUSCH HEALTH, CANADA INC. |
| SUBLINOX | 02391678 | 5 MG | TABLET (ORALLY-DISINTEGRATING) · SUBLINGUAL | BAUSCH HEALTH, CANADA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AMBIEN 10 MG TABLET | $22.61381 | per EA | 23 Sep 2026 |
| US NADAC | AMBIEN CR 12.5 MG TABLET | $22.57257 | per EA | 23 Sep 2026 |
| US NADAC | EDLUAR 10 MG SL TABLET | $15.48392 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TART 1.75 MG TAB SL | $5.04569 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TART 3.5 MG TABLET SL | $5.79015 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TART ER 12.5 MG TAB | $0.10925 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TART ER 6.25 MG TAB | $0.10153 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TARTRATE 10 MG TABLET | $0.03958 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TARTRATE 5 MG TABLET | $0.03438 | per EA | 23 Sep 2026 |
| US NADAC | ZOLPIDEM TARTRATE 7.5 MG CAP | $7.93327 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Zolpidem 10mg tablets | £1.00 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Zolpidem 5mg tablets | £0.91 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Feb 2022 AMBIEN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Feb 2022 AMBIEN CR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2019 EDLUAR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2019 INTERMEZZO — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2019 ZOLPIMIST — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Zolpidem: risk of drowsiness and reduced driving ability
Taking zolpidem is associated with a risk of impaired driving ability the next day. - EMA PRAC 13 Jun 2013 PRAC signal: Next-morning impaired mental alertness, including impaired driving ability
Action for MAH: update of the product information: No - EMA PRAC 7 Feb 2013 PRAC signal: Next-morning impaired mental alertness, including impaired driving ability
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.