MELATONIN for Somnolence: Side Effects & Safety Data
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There are 17 adverse event reports in the FDA FAERS database where MELATONIN was used for Somnolence.
Most Reported Side Effects for MELATONIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Somnolence | 642 | 15.6% | 148 | 495 |
| Intentional overdose | 640 | 15.6% | 13 | 598 |
| Off label use | 555 | 13.5% | 213 | 312 |
| Intentional self-injury | 463 | 11.3% | 0 | 444 |
| Drug ineffective | 458 | 11.1% | 94 | 243 |
| Gastrooesophageal reflux disease | 399 | 9.7% | 13 | 378 |
| Nausea | 377 | 9.2% | 225 | 164 |
| Vomiting | 341 | 8.3% | 228 | 175 |
| Coma | 336 | 8.2% | 6 | 305 |
| Constipation | 313 | 7.6% | 226 | 127 |
| Hyponatraemia | 291 | 7.1% | 246 | 151 |
| Pneumonia aspiration | 288 | 7.0% | 1 | 277 |
| Dyspnoea | 285 | 6.9% | 92 | 217 |
| Multiple organ dysfunction syndrome | 274 | 6.7% | 273 | 141 |
| Ascites | 268 | 6.5% | 238 | 111 |
Other Indications for MELATONIN
Product used for unknown indication (2,097)
Insomnia (363)
Sleep disorder (342)
Sleep disorder therapy (275)
Sleep deficit (104)
Intentional product misuse (79)
Off label use (52)
Suicide attempt (49)
Child abuse (45)
Autism spectrum disorder (26)
Other Drugs Used for Somnolence
SODIUM OXYBATE (6,551)
CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE (3,257)
SOLRIAMFETOL (240)
MODAFINIL (177)
ARMODAFINIL (143)
AMPHETAMINE ASPARTATE\AMPHETAMINE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE (73)
METHYLPHENIDATE (69)
IPRATROPIUM (50)
PITOLISANT (46)
DIPHENHYDRAMINE\IBUPROFEN (36)