ZOLPIDEM\ZOLPIDEM: 5,895 Adverse Event Reports & Safety Profile

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5,895

Total FAERS Reports

1,996 (33.9%)

Deaths Reported

2,369

Hospitalizations

5,895

As Primary/Secondary Suspect

346

Life-Threatening

Disabilities

Active Ingredient: ZOLPIDEM\ZOLPIDEM TARTRATE ·

First Report: 1988 · Latest Report: 20190601

What Are the Most Common ZOLPIDEM\ZOLPIDEM Side Effects?

#1 Most Reported

Toxicity to various agents

1,164 reports (19.7%)

#2 Most Reported

Completed suicide

1,152 reports (19.5%)

#3 Most Reported

Drug ineffective

535 reports (9.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Toxicity to various agents	1,164	19.8%	853	461
Completed suicide	1,152	19.5%	1,152	319
Drug ineffective	535	9.1%	21	47
Drug abuse	527	8.9%	138	237
Overdose	326	5.5%	85	208
Somnolence	315	5.3%	14	176
Intentional overdose	301	5.1%	78	204
Suicide attempt	286	4.9%	11	233
Coma	274	4.7%	26	225
Confusional state	268	4.6%	2	182
Drug dependence	267	4.5%	0	125
Insomnia	247	4.2%	9	41
Fall	238	4.0%	11	200
Cardio-respiratory arrest	224	3.8%	219	116
Death	179	3.0%	179	21
Hypotension	172	2.9%	28	152
Sopor	171	2.9%	0	125
Drug interaction	155	2.6%	25	53
Tachycardia	155	2.6%	16	118
Cardiac arrest	152	2.6%	138	74

Gender: 60.6% female, 39.4% male. Average age: 52.2 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2000	3	1	1
2002	3	0	3
2003	2	0	2
2004	4	0	1
2005	3	0	2
2006	7	6	1
2008	2	0	1
2009	5	1	4
2010	15	3	4
2011	17	0	14
2012	85	28	34
2013	166	92	50
2014	330	75	140
2015	388	86	205
2016	436	125	190
2017	528	116	263
2018	567	23	354
2019	125	1	73

Indication	Reports
Product used for unknown indication	2,843
Insomnia	1,017
Sleep disorder	262
Suicide attempt	158
Depression	65
Anxiety	58
Completed suicide	48
Drug abuse	47
Intentional overdose	46
Intentional self-injury	35

Official prescribing information from the FDA-approved drug label.