Overview
Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 . Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms , . Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance . In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties . Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury , .
Background
Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 . Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms , . Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance . In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties . Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury , .
Indication
This drug is indicated for the short-term treatment of insomnia in adults characterized by difficulties with sleep initiation .
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/16 | Phase 3 | Recruiting | |||
2025/01/30 | Phase 4 | Completed | |||
2024/11/12 | Phase 1 | Completed | |||
2024/07/22 | Phase 1 | Completed | Mengchang Yang | ||
2024/03/12 | Phase 4 | Not yet recruiting | |||
2024/02/06 | Not Applicable | Recruiting | |||
2023/10/16 | Phase 4 | Not yet recruiting | |||
2023/02/27 | Phase 4 | Recruiting | |||
2022/11/14 | Phase 3 | Recruiting | |||
2022/09/14 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Par Pharmaceutical, Inc. | 49884-903 | SUBLINGUAL | 5 mg in 1 1 | 9/17/2018 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-254 | ORAL | 12.5 mg in 1 1 | 3/26/2019 | |
| NuCare Pharmaceuticals,Inc. | 68071-3455 | ORAL | 10 mg in 1 1 | 12/6/2023 | |
| STAT Rx USA LLC | 16590-010 | ORAL | 10 mg in 1 1 | 9/18/2012 | |
| A-S Medication Solutions | 50090-1022 | ORAL | 5 mg in 1 1 | 10/11/2022 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-390 | ORAL | 5 mg in 1 1 | 4/3/2024 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0060 | ORAL | 10 mg in 1 1 | 11/11/2022 | |
| NorthStar Rx LLC | 16714-622 | ORAL | 10 mg in 1 1 | 1/30/2024 | |
| H.J. Harkins Company, Inc. | 52959-880 | ORAL | 10 mg in 1 1 | 8/19/2011 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-617 | ORAL | 10 mg in 1 1 | 4/10/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| STILNOX CR 12.5mg Modified Release Tablet | SIN13403P | TABLET, MULTILAYER, EXTENDED RELEASE | 6.0mg & 6.5mg | 1/28/2008 | |
| STILNOX CR 6.25mg Modified Release Tablet | SIN13402P | TABLET, MULTILAYER, EXTENDED RELEASE | 3.000mg & 3.250mg | 1/28/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Zolpidem Tartrate Dispersible Tablets | 国药准字H20080283 | 化学药品 | 片剂 | 12/13/2022 | |
| Zolpidem Tartrate Orally Disintegrating Tablets | 国药准字H20120043 | 化学药品 | 片剂 | 3/3/2022 | |
| Zolpidem Tartrate Orally Disintegrating Tablets | 国药准字H20120044 | 化学药品 | 片剂 | 3/3/2022 | |
| Zolpidem Tartrate Tablets | 国药准字H20010611 | 化学药品 | 片剂 | 12/27/2019 | |
| Zolpidem Tartrate Tablets | 国药准字H20000276 | 化学药品 | 片剂 | 12/27/2019 | |
| Zolpidem Tartrate Tablets | 国药准字H20020372 | 化学药品 | 片剂 | 5/20/2020 | |
| Zolpidem Tartrate Tablets | 国药准字H20020065 | 化学药品 | 片剂（薄膜衣） | 5/18/2020 | |
| Zolpidem Tartrate Tablets | 国药准字H20031147 | 化学药品 | 片剂 | 3/24/2021 | |
| Zolpidem Tartrate Tablets | 国药准字H20000114 | 化学药品 | 片剂 | 6/30/2020 | |
| Zolpidem Tartrate Tablets | 国药准字HJ20181238 | 化学药品 | 片剂 | 8/31/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ZOTILNOX TABLETS 10MG | N/A | N/A | N/A | 4/23/2025 | |
| ZOLPIDEM HBPHARMA TABLETS 10MG | N/A | N/A | N/A | 4/23/2025 | |
| SLEEPNOX TABLETS 10MG | N/A | N/A | N/A | 4/23/2025 | |
| ZORIMIN TABLETS 10 MG | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 9/30/2017 |
| ZOLPIDEM STADA TABLETS 10MG | N/A | N/A | N/A | 4/22/2013 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZOLPIBELL zolpidem tartrate 10mg tablet blister pack | 119087 | Medicine | A | 7/26/2006 | |
| PHARMACOR ZOLPIDEM zolpidem tartrate 10mg tablet blister pack | 131918 | Medicine | A | 7/23/2007 | |
| ZOLPIDEM-LUPIN zolpidem tartrate 10 mg tablet blister pack | 135016 | Medicine | A | 4/24/2008 | |
| STILNOX CR Zolpidem tartrate 12.5mg modified release tablet blister pack | 120713 | Medicine | A | 7/6/2006 | |
| STILDEM zolpidem tartrate 10 mg tablet blister pack | 131917 | Medicine | A | 7/23/2007 | |
| ZOLPIDEM SANDOZ PHARMA zolpidem tartrate 10 mg tablet blister pack | 116893 | Medicine | A | 7/24/2006 | |
| ZOLPIDEM SANDOZ PHARMA zolpidem tartrate 10 mg tablet bottle | 116906 | Medicine | A | 7/24/2006 | |
| STILNOX Zolpidem tartrate 10mg tablet blister pack | 69681 | Medicine | A | 9/10/1999 | |
| APO-ZOLPIDEM zolpidem 5mg tablet bottle | 127167 | Medicine | A | 7/17/2007 | |
| DORMIZOL Zolpidem tartrate 10mg tablet blister pack | 117953 | Medicine | A | 6/14/2005 |