MYSLEE: 45 Adverse Event Reports & Safety Profile
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45
Total FAERS Reports
1 (2.2%)
Deaths Reported
20
Hospitalizations
45
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities
First Report: 20110716 · Latest Report: 20140518
What Are the Most Common MYSLEE Side Effects?
#1 Most Reported
Road traffic accident
6 reports (13.3%)
#2 Most Reported
Loss of consciousness
6 reports (13.3%)
#3 Most Reported
Off label use
5 reports (11.1%)
All MYSLEE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Loss of consciousness | 6 | 13.3% | 0 | 6 |
| Road traffic accident | 6 | 13.3% | 0 | 0 |
| Intentional overdose | 5 | 11.1% | 0 | 1 |
| Off label use | 5 | 11.1% | 0 | 4 |
Who Reports MYSLEE Side Effects? Age & Gender Data
Average age: 64.9 years. Most reports from: JP. View detailed demographics →
Is MYSLEE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2013 | 13 | 0 | 10 |
| 2014 | 16 | 0 | 9 |
What Is MYSLEE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 19 |
| Insomnia | 16 |
Official FDA Label for MYSLEE
Official prescribing information from the FDA-approved drug label.