Initial insomnia adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 10,040 adverse event reports that record the MedDRA preferred term Initial insomnia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 574 reports in the 12 months to June 2026 and 826 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 913 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 574 (under 0.1%) record this term. Reports for female patients were 59.2% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 102 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Initial insomnia name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	31
Acetaminophen		41
Adderall	Central nervous system stimulant	36
Albuterol	beta2-Adrenergic agonist	34
Aleve	Nonsteroidal anti-inflammatory drug	40
Allopurinol	Xanthine oxidase inhibitor	36
Alprazolam	Benzodiazepine	62
Ambien	gamma-Aminobutyric acid A receptor positive modulator	45
Ampyra	Potassium channel blocker	104
Aripiprazole	Atypical antipsychotic	37
Atorvastatin		58
Avonex	Interferon beta	36
Belsomra	Orexin receptor antagonist	77
Benserazide Levodopa		29
Betahistine		32
Carbidopa levodopa	Aromatic amino acid	150
Chantix	Partial cholinergic nicotinic agonist	115
Ciprofloxacin	Fluoroquinolone antibacterial	26
Citalopram	Serotonin reuptake inhibitor	59
Comirnaty		30
Cortisone	Corticosteroid	42
Cosentyx	Interleukin-17A antagonist	26
Cyclophosphamide	Alkylating drug	57
Cymbalta		53
Dabigatran		36
Daytrana	Central nervous system stimulant	25
Denosumab	RANK ligand inhibitor	26
Diazepam	Benzodiazepine	25
Donepezil		35
Duodopa		62
Dupixent	Interleukin-4 receptor alpha antagonist	590
Enbrel	Tumor necrosis factor blocker	62
Entresto	Angiotensin 2 receptor blocker	63
Epirubicin		40
Escitalopram	Serotonin reuptake inhibitor	26
Fluoxetine	Serotonin reuptake inhibitor	45
Forteo	Parathyroid hormone analog	60
Furosemide	Loop diuretic	36
Gabapentin	Anti-epileptic agent	46
Gilenya	Sphingosine 1-phosphate receptor modulator	33
Gliclazide		38
Hetlioz	Melatonin receptor agonist	151
Humira		123
Hydrochlorothiazide	Thiazide diuretic	38
Hydroxyzine	Antihistamine	38
Ibrance	Kinase inhibitor	40
Imbruvica	Kinase inhibitor	30
Ingrezza	Vesicular monoamine transporter 2 inhibitor	25
Isosorbide mononitrate	Nitrate vasodilator	34
Jakafi	Janus kinase inhibitor	36
Keppra		35
Lamictal	Anti-epileptic agent	25
Latuda	Atypical antipsychotic	35
Levothyroxine		41
Levothyroxine sodium	l-Thyroxine	26
Lumryz	Central nervous system depressant	429
Lunesta		813
Lyrica		62
Metformin	Biguanide	35
Methotrexate	Folate analog metabolic inhibitor	57
Metoclopramide	Dopamine-2 receptor antagonist	41
Metoprolol	beta-Adrenergic blocker	65
Mirtazapine		35
Niaspan		46
Niraparib	Poly(ADP-Ribose) polymerase inhibitor	38
Novothyrox		45
Nuplazid	Atypical antipsychotic	54
Ocrevus	CD20-directed cytolytic antibody	112
Olanzapine	Atypical antipsychotic	37
Omeprazole	Proton pump inhibitor	45
Orgovyx	Gonadotropin releasing hormone receptor antagonist	30
Otezla	Phosphodiesterase 4 inhibitor	36
Paxil	Serotonin reuptake inhibitor	28
Paxlovid		28
Potassium chloride	Osmotic laxative	35
Pregabalin		39
Quetiapine	Atypical antipsychotic	90
Quetiapine fumarate	Atypical antipsychotic	25
Ramipril	Angiotensin converting enzyme inhibitor	50
Revlimid	Thalidomide analog	50
Risperidone	Atypical antipsychotic	36
Rozerem	Melatonin receptor agonist	433
Seroquel	Atypical antipsychotic	76
Sertraline	Serotonin reuptake inhibitor	38
Simcor		26
Singulair	Leukotriene receptor antagonist	40
Spironolactone	Aldosterone antagonist	38
Strattera	Norepinephrine reuptake inhibitor	53
Tecfidera		54
Torsemide	Loop diuretic	28
Tramadol		41
Trazodone		42
Tymlos		69
Tysabri	Integrin receptor antagonist	55
Viekira Pak		25
Vyvanse	Central nervous system stimulant	72
Xeljanz	Janus kinase inhibitor	44
Xtandi	Androgen receptor inhibitor	56
Xyrem	Central nervous system depressant	500
Zejula	Poly(ADP-Ribose) polymerase inhibitor	55
Zolpidem	gamma-Aminobutyric acid A receptor positive modulator	92
Zolpidem tartrate	gamma-Aminobutyric acid A receptor positive modulator	40

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 43 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Initial insomnia name, in order of name
Class	Reports with this term
Alkylating drug	57
Aminoketone	66
Androgen receptor inhibitor	68
Angiotensin 2 receptor blocker	84
Angiotensin converting enzyme inhibitor	55
Anti-epileptic agent	110
Antihistamine	53
Aromatic amino acid	171
Atypical antipsychotic	526
Benzodiazepine	170
beta-Adrenergic blocker	100
CD20-directed cytolytic antibody	165
Central nervous system depressant	950
Central nervous system stimulant	200
Corticosteroid	181
Dopamine-2 receptor antagonist	54
Folate analog metabolic inhibitor	71
gamma-Aminobutyric acid A receptor positive modulator	177
GLP-1 receptor agonist	61
Histamine-1 receptor antagonist	68
HMG-CoA reductase inhibitor	78
Integrin receptor antagonist	57
Interferon beta	50
Interleukin-4 receptor alpha antagonist	603
Janus kinase inhibitor	98
Kinase inhibitor	139
Leukotriene receptor antagonist	70
Loop diuretic	64
Melatonin receptor agonist	584
Nonsteroidal anti-inflammatory drug	106
Norepinephrine reuptake inhibitor	63
Opioid agonist	86
Orexin receptor antagonist	98
Osmotic laxative	51
Parathyroid hormone analog	60
Partial cholinergic nicotinic agonist	115
Poly(ADP-Ribose) polymerase inhibitor	109
Potassium channel blocker	121
Proton pump inhibitor	96
Serotonin and norepinephrine reuptake inhibitor	66
Serotonin reuptake inhibitor	326
Thalidomide analog	68
Tumor necrosis factor blocker	99

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Initial insomnia, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Initial insomnia
Age	Reports	Share
Under 2	41	0.4%
2 to 11	332	3.3%
12 to 17	188	1.9%
18 to 44	1,648	16.4%
45 to 64	2,369	23.6%
65 to 74	1,107	11%
75 and over	876	8.7%
Age not given	3,479	34.7%

Sex of the patient in the reports that record Initial insomnia
Sex	Reports	Share
Female	5,942	59.2%
Male	3,446	34.3%
Unknown or not given	652	6.5%

Age and sex are as the report gives them. 79% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Initial insomnia: adverse event reports that record this term. https://reportedreactions.com/reaction/initial-insomnia/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Initial insomnia mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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