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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.

DARIDOREXANT: 2,016 Adverse Event Reports & Safety Profile

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2,016
Total FAERS Reports
38 (1.9%)
Deaths Reported
77
Hospitalizations
2,016
As Primary/Secondary Suspect
20
Life-Threatening
11
Disabilities
Apr 7, 2022
FDA Approved
Prescription
Status

FDA Application: 214985 ·

Patent Expires: Jun 12, 2033 · First Report: 20210809 · Latest Report: 20250923

What Are the Most Common DARIDOREXANT Side Effects?

#1 Most Reported
Drug ineffective
432 reports (21.4%)
#2 Most Reported
Nightmare
265 reports (13.1%)
#3 Most Reported
Insomnia
262 reports (13.0%)

All DARIDOREXANT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 432 21.4% 1 2
Nightmare 265 13.1% 0 1
Insomnia 262 13.0% 1 2
Somnolence 151 7.5% 0 4
Product availability issue 146 7.2% 0 0
Fatigue 134 6.7% 0 0
Headache 128 6.4% 0 0
Abnormal dreams 123 6.1% 0 0
Feeling abnormal 114 5.7% 0 1
Inappropriate schedule of product administration 114 5.7% 0 1
Wrong technique in product usage process 82 4.1% 0 1
Therapeutic product effect incomplete 71 3.5% 0 0
Hallucination 65 3.2% 0 1
Dizziness 59 2.9% 0 3
Nausea 56 2.8% 0 1
Sleep paralysis 53 2.6% 0 0
Depression 52 2.6% 0 2
Middle insomnia 52 2.6% 0 0
Suicidal ideation 51 2.5% 0 5
Anxiety 48 2.4% 0 1

Who Reports DARIDOREXANT Side Effects? Age & Gender Data

Gender: 65.1% female, 34.9% male. Average age: 59.4 years. Most reports from: US. View detailed demographics →

Is DARIDOREXANT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2021 1 0 0
2022 184 2 1
2023 277 8 7
2024 95 4 15
2025 101 5 21

View full timeline →

What Is DARIDOREXANT Used For?

IndicationReports
Insomnia 1,685
Product used for unknown indication 275
Sleep disorder 16
Toxicity to various agents 5

DARIDOREXANT vs Alternatives: Which Is Safer?

DARIDOREXANT vs DARIFENACIN HYDROBROMIDE DARIDOREXANT vs DAROLUTAMIDE DARIDOREXANT vs DARUNAVIR DARIDOREXANT vs DARUNAVIR ETHANOLATE DARIDOREXANT vs DARUNAVIR\RITONAVIR DARIDOREXANT vs DASABUVIR DARIDOREXANT vs DASABUVIR\OMBITASVIR HEMINONAHYDRATE\PARITAPREVIR\RITONAVIR DARIDOREXANT vs DASABUVIR\OMBITASVIR\PARITAPREVIR\RITONAVIR DARIDOREXANT vs DASATINIB DARIDOREXANT vs DATOPOTAMAB DERUXTECAN-DLNK

Official FDA Label for DARIDOREXANT

Official prescribing information from the FDA-approved drug label.