Medication approval journey
diazepam (Valium)
Approved for Anxiety disorders; short-term relief of anxiety symptoms
Before changing anything
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop a benzodiazepine abruptly. Abrupt withdrawal can cause seizures, delirium, and can be fatal. Physical dependence develops within weeks of daily use and is not the same thing as addiction. Coming off safely is a prescriber-supervised taper measured in months, sometimes far longer, and going slower is not failure.
How long the trials actually ran
We could not establish a longest trial length for diazepam. That is a gap in what we can show you — not evidence that the trials ran long.
Approved before the Physician Labeling Rule, so no clinical studies section was ever required. The absence is the state of the public record, not a gap in our research.
The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.
The boxed warning
The strongest warning the FDA puts on a label, reproduced word for word — not our summary of it.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including VALIUM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALIUM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ) . The continued use of benzodiazepines, including VALIUM, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of VALIUM after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALIUM or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ) .
FDA label effective August 11, 2026 — read the full label on DailyMed
How many Americans take diazepam
Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.
- 3,346,943
- prescriptions in the United States (2024)
- 1,047,987
- people filling them (2024)
Prescriptions are down 63% since 2014. Whatever you decide about diazepam, you are deciding alongside about 1,047,987 other people this year.
Source: ClinCalc DrugStats (Medical Expenditure Panel Survey (MEPS), Agency for Healthcare Research and Quality), CC BY-SA 4.0, release 2026.08.
What people report to the FDA about diazepam
Read this before the numbers.
Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.
- 121,002
- reports mentioning diazepam, all time
- 98,058
- filed as serious (a report-level flag covering every drug and outcome in the report)
Most-reported reactions
- Toxicity to various agents9,514
- Drug ineffective7,286
- Drug abuse7,212
- Nausea6,288
- Fatigue5,838
- Pain5,269
- Anxiety5,086
- Somnolence5,077
- Headache5,071
- Off label use4,809
“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.
Source: FDA Adverse Event Reporting System (FAERS), via openFDA, data through 2026-07-30.
Known interactions, from the label
The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.
Read the label’s interactions section
Drug Interactions Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid- related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. Centrally Acting Agents If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants. Alcohol Concomitant use with alcohol is not recommended due to enhancement of the sedative effect. Antacids Diazepam peak concentrations are 30% lower when antacids are administered concurrently. However, there is no effect on the extent of absorption. The lower peak concentrations appear due to a slower rate of absorption, with the time required to achieve peak concentrations on average 20 - 25 minutes greater in the presence of antacids. However, this difference was not statistically significant. Compounds Which Inhibit Certain Hepatic Enzymes There is a potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. Phenytoin There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.
FDA label for diazepam, effective August 11, 2026 — DailyMed.
Who pays for diazepam
Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.
- Medicare Part D
- 939,381 beneficiaries filled 3,011,861 claims in 2024 — 714,054 aged 65 and over, and 225,327 under 65. The under-65 group is not a picture of ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error.
- Medicaid
- At least 1,304,365 prescriptions in 2024 — a floor, because 166 of 567 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.
- All payers (survey estimate)
- The MEPS-based estimate above puts the whole country at 3,346,943 prescriptions and 1,047,987 people in 2024. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.
- The population nobody counts
- The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of diazepam specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.
Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.
The approval, step by step
Step 1
What the approval was actually based on
Which studies did the FDA rely on, how long did they run, and who was in them?
Our reading
Approved in 1963 — one year after the law first required efficacy evidence at all — and the current label carries no clinical studies section. Valium became, for a stretch of the 1970s, the most prescribed drug in America; whatever trial record sat under that phenomenon has never been printed on the document patients see. Sixty submissions have been filed against the application in six decades, and the application itself has changed hands from Roche to a company most people have never heard of, which is what the end of a blockbuster looks like in regulatory records.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- November 15, 1963
- Application
- NDA013263
- Review
- STANDARD
- Original sponsor
- Roche
- Holds it now
- Waylis Therapeutics
- Label submissions since
- 60
Source: openFDA Drugs@FDA, original application ORIG-1
Step 3
What was added after it was on the market
Which warnings arrived only after millions of people were already taking it?
The FDA strengthened the benzodiazepine warning in 2020
57 years after approval
In September 2020 the FDA required the boxed warning on every benzodiazepine to be rewritten. The wording matters: physical dependence can develop even when the medication is taken exactly as prescribed, and stopping abruptly or dropping the dose quickly can cause withdrawal reactions that include seizures and can be life-threatening.
This is not a claim that the medication is bad or that you should stop taking it. It is the opposite. It is the reason not to stop on your own. The FDA's own instruction to prescribers is to taper gradually rather than stop, and to reassess dose and duration over time.
Worth asking
How long is the plan for me to be on this, what does my taper look like if we decide to come off, and how will we tell withdrawal apart from my original anxiety coming back.
Step 4
What independent research has found since
What has been learned by people who were not selling it?
Withdrawal from these medications can take months, and NICE says so
59 years after approval
NICE guideline NG215 covers safe prescribing and managed withdrawal for five groups of medication: opioids, benzodiazepines, gabapentinoids, Z-drugs and antidepressants. It is the closest thing there is to an official answer on how coming off actually goes.
It states that withdrawal can be difficult and may take several months or more, that symptoms vary widely in type and severity, that they affect both physical and mental health, and that they can be delayed in onset and can persist. Two recommendations are worth quoting to a prescriber. Do not stop a medicine abruptly except in exceptional medical circumstances. And taper using a slow, stepwise reduction proportionate to the current dose, so the decrements get smaller as the dose gets lower — not a fixed cut each time.
That last detail is the one most commonly missed. Gabapentinoids are the exception in the guideline and are reduced by a fixed amount at each step.
Worth asking
Can we write the taper down, what size are the steps near the end, and how long do I hold at each step before the next reduction.
Step 5
What still is not known
Which questions you might reasonably have has nobody answered yet?
- Once the most prescribed drug in the country, and the label never printed the trials. What was the evidence at approval?
- The class boxed warning on dependence arrived in 2020, fifty-seven years after approval.
- Like lorazepam, the label describes short-term use. What is the plan if this prescription is in its fifth year?
Deciding about diazepam?
- 12 questions to ask before starting a psychiatric medication — each with the study behind it
- Already on it? The 10-question annual review — including the honest case for staying
- How long every drug here was tested before approval — one chart, all medications
Open diazepam (Valium) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
