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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

RESTORIL: 35 Adverse Event Reports & Safety Profile

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35
Total FAERS Reports
19 (54.3%)
Deaths Reported
6
Hospitalizations
35
As Primary/Secondary Suspect

First Report: 1998 · Latest Report: 20140130

What Are the Most Common RESTORIL Side Effects?

#1 Most Reported
Drug abuse
8 reports (22.9%)
#2 Most Reported
Completed suicide
8 reports (22.9%)
#3 Most Reported
Muscle spasticity
4 reports (11.4%)

All RESTORIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Completed suicide 8 22.9% 8 0
Drug abuse 8 22.9% 8 0

Who Reports RESTORIL Side Effects? Age & Gender Data

Average age: 54.9 years. Most reports from: US. View detailed demographics →

Is RESTORIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 1 0
2013 4 0 0
2014 2 0 2

View full timeline →

What Is RESTORIL Used For?

IndicationReports
Product used for unknown indication 21
Insomnia 5

Official FDA Label for RESTORIL

Official prescribing information from the FDA-approved drug label.