BACLOFEN for Insomnia: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where BACLOFEN was used for Insomnia.
Most Reported Side Effects for BACLOFEN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Muscle spasticity | 2,893 | 11.2% | 50 | 872 |
| Drug withdrawal syndrome | 2,284 | 8.9% | 52 | 1,070 |
| Pain | 2,048 | 8.0% | 78 | 612 |
| Toxicity to various agents | 1,868 | 7.3% | 818 | 1,037 |
| Overdose | 1,554 | 6.0% | 118 | 968 |
| Off label use | 1,454 | 5.7% | 134 | 589 |
| Drug ineffective | 1,445 | 5.6% | 33 | 405 |
| Somnolence | 1,433 | 5.6% | 28 | 884 |
| Muscle spasms | 1,279 | 5.0% | 20 | 427 |
| Coma | 1,133 | 4.4% | 49 | 906 |
| Completed suicide | 1,112 | 4.3% | 1,112 | 277 |
| Fall | 1,057 | 4.1% | 51 | 442 |
| Nausea | 943 | 3.7% | 18 | 363 |
| Encephalopathy | 845 | 3.3% | 19 | 326 |
| Vomiting | 828 | 3.2% | 40 | 453 |
Other Indications for BACLOFEN
Product used for unknown indication (6,968)
Muscle spasticity (6,787)
Pain (1,388)
Cerebral palsy (882)
Muscle spasms (824)
Multiple sclerosis (712)
Spinal cord injury (434)
Alcoholism (383)
Musculoskeletal pain (364)
Back pain (333)
Other Drugs Used for Insomnia
SUVOREXANT (6,209)
ZOLPIDEM (3,623)
ZOPICLONE (1,968)
DARIDOREXANT (1,685)
QUETIAPINE (1,559)
TRAZODONE (1,527)
SODIUM OXYBATE (1,334)
DOXYLAMINE (1,056)
ZOLPIDEM\ZOLPIDEM (1,017)
CLONAZEPAM (1,003)