Treats insomnia characterized. NDA 19908, held by Cosette. Zolpidem Tartrate.
As of Nov 13, 2026, NDA 19908 (Ambien), held by Cosette, was first approved by FDA on Dec 16, 1992, with 31 approved supplements and 0 published complete response letters.
AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2007 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Dec 16, 1992 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ambien5MG · tablet;oral | Zolpidem Tartrate | RxReference drug |
| Ambien10MG · tablet;oral | Zolpidem Tartrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2022 | Supplement 47Labeling · Standard review | Approved | |
| Feb 23, 2022 | Supplement 44Labeling · Standard review | Approved | |
| Feb 23, 2022 | Supplement 40Labeling · Standard review | Approved | |
| Aug 18, 2019 | Supplement 46Labeling · Standard review | Approved | |
| Feb 6, 2019 | Supplement 45Labeling | Approved | |
| Sep 14, 2018 | Supplement 42Labeling · Standard review | Approved | |
| Mar 3, 2017 | Supplement 38Labeling · Standard review | Approved | |
| Dec 2, 2016 | Supplement 37Labeling · Standard review | Approved | |
| Aug 11, 2016 | Supplement 36Labeling · Standard review | Approved | |
| Oct 7, 2014 | Supplement 35Labeling · Standard review | Approved | |
| Jun 5, 2013 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Apr 19, 2013 | Supplement 34Labeling | Approved | |
| Apr 19, 2013 | Supplement 32Labeling · Standard review | Approved | |
| Apr 14, 2010 | Supplement 29Labeling | Approved | |
| May 7, 2008 | Supplement 27Labeling · Standard review | Approved | |
| Oct 4, 2007 | Supplement 25Labeling · Standard review | Approved | |
| Oct 4, 2007 | Supplement 24Labeling · Standard review | Approved | |
| Oct 4, 2007 | Supplement 20Labeling · Standard review | Approved | |
| Mar 28, 2007 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Sep 25, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 21, 2002 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2002 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Nov 15, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 4, 2001 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 13, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1999 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 18, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 4, 1995 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 14, 1995 | Supplement 2Labeling · Standard review | Approved | |
| Jul 14, 1995 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 9, 1995 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1992 | Original applicationNew molecular entity · 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
