Treats insomnia characterized. NDA 21774, held by Cosette. Zolpidem Tartrate.
As of Nov 14, 2026, NDA 21774 (Ambien Cr), held by Cosette, was first approved by FDA on Sep 2, 2005, with 18 approved supplements and 0 published complete response letters.
AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration.
| Dec 20, 2007 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| Sep 2, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Ambien Cr12.5MG · tablet, extended release;oral | Zolpidem Tartrate | RxReference drug |
| Ambien Cr6.25MG · tablet, extended release;oral | Zolpidem Tartrate | RxReference drug |
| Feb 23, 2022 | Supplement 28Labeling · Standard review | Approved | |
| Feb 23, 2022 | Supplement 25Labeling · Standard review | Approved | |
| Feb 23, 2022 | Supplement 21Labeling · Standard review | Approved | |
| Aug 18, 2019 | Supplement 27Labeling · Standard review | Approved | |
| Feb 6, 2019 | Supplement 26Labeling | Approved | |
| Sep 14, 2018 | Supplement 23Labeling · Standard review | Approved | |
| Mar 3, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Dec 2, 2016 | Supplement 18Labeling · Standard review | Approved | |
| Aug 11, 2016 | Supplement 17Labeling · Standard review | Approved | |
| Oct 7, 2014 | Supplement 16Labeling · Standard review | Approved | |
| Apr 19, 2013 | Supplement 15Labeling · Standard review | Approved | |
| Apr 19, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Apr 14, 2010 | Supplement 10Labeling | Approved | |
| Dec 20, 2007 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 7Labeling · Standard review | Approved | |
| Dec 20, 2007 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| Sep 2, 2005 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
