Diazepam (Valium): Independent Evidence on Anxiety, Side Effects & Withdrawal

Key takeaways
  • Diazepam (Valium) is a long-acting benzodiazepine, available on prescription only, and is used for severe anxiety, seizures, muscle spasm and alcohol withdrawal. The NHS says it "should only be used short term, up to 4 weeks" because longer use can cause addiction and withdrawal symptoms (NHS diazepam).
  • It works quickly, but guidelines do not recommend it as an ongoing treatment for anxiety. NICE says not to offer a benzodiazepine for generalised anxiety disorder "except as a short-term measure during crises" and not to prescribe one for panic disorder (NICE CG113). WHO makes a strong recommendation against benzodiazepines for GAD and panic disorder, allowing them only in emergencies for 3–7 days at most (WHO mhGAP 2023).
  • For panic disorder, an unfunded Cochrane review found benzodiazepines beat placebo in the short term (response RR 1.65, number needed to treat 4). The evidence was low quality, only 2 of the 24 trials tested diazepam, and nearly all the trials were sponsored by benzodiazepine makers or did not say who funded them (Breilmann et al., Cochrane 2019).
  • In alcohol withdrawal, benzodiazepines prevented seizures better than placebo (RR 0.16; 3 trials, 324 people) in a Cochrane review funded by Italy's public medicines agency (Amato et al., Cochrane 2010). For acute low back pain, an independent trial found that adding diazepam to naproxen was no better than adding placebo (Friedman et al., Ann Emerg Med 2017).
  • The US label carries a boxed warning. Taking diazepam with opioids can cause profound sedation, breathing problems, coma and death. Diazepam itself carries risks of abuse, addiction, physical dependence, and withdrawal reactions that can be life-threatening (FDA Valium label; FDA 2020).
  • Diazepam is one of the medicines covered by the drug-driving law in England and Wales, with a blood limit of 550 µg/L (Department for Transport). The 2023 Beers Criteria tell clinicians to avoid benzodiazepines in adults aged 65 and over (AGS Beers 2023).
  • Money trail: Roche, founded in Basel, Switzerland, launched Valium in 1963 (Roche; Wick 2013). The US Valium tablet licence is now held by Waylis Therapeutics, and diazepam is widely available as a cheap generic (Drugs@FDA via openFDA).

Independent evidence review · Prescription medicine

Diazepam (Valium) has been prescribed since 1963 and is one of the best-known medicines ever made. It calms anxiety within hours, stops some seizures, relaxes muscle spasm and protects against seizures during alcohol withdrawal. Its evidence is strongest for emergencies and short, supervised courses. For long-term anxiety treatment it is weak and largely industry-generated. The main risks are drowsiness, falls, memory problems, dangerous interactions with opioids and alcohol, dependence, and withdrawal reactions that can last months. For these reasons the NHS limits it to courses of up to 4 weeks, and NICE and WHO advise against it as an ongoing anxiety treatment. This review leads with evidence from regulators (FDA, MHRA), NICE, WHO and Cochrane, and labels manufacturer-sponsored trials as such (NHS, NICE CG113, Cochrane 2019).

Best evidence for short-term relief of severe anxiety, emergency treatment of prolonged seizures, and preventing seizures during alcohol withdrawal
Main risks drowsiness, falls, memory loss, dependence and withdrawal, fatal breathing problems with opioids or alcohol, drug-driving offences
Key rule short courses only (NHS: up to 4 weeks); never combine with alcohol or opioids unless a prescriber has planned it; never stop suddenly after regular use
Safety first
Diazepam is a prescription-only controlled medicine. Do not start it, stop it or change your dose without talking to the prescriber who manages your treatment.
  • Stopping: if you have taken it regularly, stopping suddenly can cause withdrawal reactions, including seizures, which can be life-threatening (FDA).
  • Opioids and alcohol: taking diazepam with opioid painkillers, opioid cough medicines, methadone, alcohol or other sedatives can slow or stop breathing. Call 999 or your local emergency number straight away if someone taking diazepam is very hard to wake, confused, or breathing slowly or shallowly (MHRA). The NHS says not to drink alcohol while taking diazepam.
  • Driving: do not drive, cycle or use machinery if you feel sleepy (NHS). Diazepam is covered by the UK drug-driving law.
  • Overdose: if you or a child have taken more than the prescribed dose, call NHS 111 (UK). If you are told to go to A&E, do not drive yourself.
  • Low mood: if you have thoughts of harming yourself, seek urgent help now.

Table of contents

Evidence summary

This table sets out the main claims made about diazepam and how strong the human evidence behind each one is. The funding column shows who paid for each source.

Claim Evidence Source Funding / conflict Strength
Benzodiazepines relieve panic disorder symptoms in the short term 24 double-blind RCTs with 4,233 participants. Response RR 1.65 (95% CI 1.39–1.96), NNTB 4. Low-quality evidence, short-term only, probable publication bias. Only 2 trials included diazepam (Garvey 1989, Noyes 1996). Breilmann et al., Cochrane 2019 The review had no funding. One author declared lecture fees from several drug companies. Almost every included trial was sponsored by a benzodiazepine maker (Hoffmann-La Roche, Upjohn, Bristol-Myers Squibb) or did not report its funder. Weak
Benzodiazepines reduce anxiety in GAD but are poorly tolerated Network meta-analysis of 89 trials with 25,441 patients. Benzodiazepines were "effective but also poorly tolerated" compared with placebo. Slee et al., Lancet 2019 "No funding was received." The underlying trials were largely industry-run. Moderate
Diazepam is not a recommended ongoing treatment for GAD or panic disorder NICE: no benzodiazepine for GAD except short-term in crises, and none for panic disorder. WHO: strong recommendation against, with emergency use limited to 3–7 days. NICE CG113; WHO mhGAP 2023 Publicly funded guideline bodies Strong (guideline consensus)
Long-term benefit beyond about 8–13 weeks is unproven Only 8 long-term studies (N = 1,228). No significant difference from placebo in HAM-A change. The US label says effectiveness beyond 4 months "has not been assessed by systematic clinical studies". Shinfuku et al. 2019; FDA label Academic (Japan); funding not stated in the PubMed record. The label is maintained by the manufacturer and approved by the FDA. Insufficient
Benzodiazepines prevent seizures during alcohol withdrawal 64 RCTs with 4,309 participants. Seizures vs placebo RR 0.16 (0.04–0.69; 3 studies, 324 people). No firm conclusions on other outcomes because the trials varied so much. Amato et al., Cochrane 2010; NICE CG100 Funded by AIFA, Italy's public medicines agency. Authors declared no conflicts. Moderate
Diazepam stops prolonged seizures (status epilepticus) IV diazepam vs placebo: non-cessation of seizures RR 0.73 (0.57–0.92). Rectal diazepam gel vs placebo RR 0.43 (0.30–0.62). IV lorazepam beat IV diazepam (RR 0.64). Prasad et al., Cochrane 2014; NICE NG217 Academic support (India, Bahrain); no conflicts known Moderate
Diazepam helps acute low back pain RCT with 114 patients. Adding diazepam to naproxen gave no better function or pain at 1 week or 3 months than adding placebo, and more adverse events were reported (21% vs 15%). Friedman et al., Ann Emerg Med 2017 Academic translational-research grant; no conflicts Not supported
Taking it with opioids can be fatal FDA boxed warnings added in 2016. The MHRA says to co-prescribe only if there is no alternative. FDA 2016; MHRA 2020 Regulators Established risk
Dependence, addiction and withdrawal, sometimes long-lasting FDA class-wide boxed warning (2020). Withdrawal symptoms in some patients lasted "many months". MHRA strengthened UK warnings in 2026. FDA 2020; MHRA 2026 Regulators Established risk
Harm in older adults (falls, fractures, delirium, crashes) Beers 2023: avoid. Evidence rated moderate; recommendation rated strong. AGS Beers 2023 Professional society; some panel members declared consulting ties Established risk

Independent evidence and credibility scorecard

Independence tiers: 1 = government regulator or public body; 2 = academic work with no relevant industry funding; 3 = academic work with some industry ties, or resting on trials mostly run by manufacturers; 4 = manufacturer or seller. The credibility grade (A–D) combines method quality with independence.

Source Who funds it Country Independence tier (1–4) Credibility (A–D) Why it would tell the truth / residual bias
NICE (CG113, CG100, NG215, NG217, NG59) Department of Health and Social Care grant-in-aid (about 70% of spending); some fees from companies for technology appraisals (NICE accounts 2024/25) UK 1 A− Its job is to protect the NHS budget and patients, so it has no reason to promote a cheap generic. Parts of CG113 on panic date from 2004, and committee conflicts were not checked here.
WHO mhGAP guideline (2023) WHO International 1 A− A global public-health mandate. The recommendation is strong even though WHO rated the certainty of the evidence low, a judgement it made because it weighed the harms as greater than the benefits.
FDA label and Drug Safety Communications US government. About 77% of drug-review costs come from industry user fees (FDA PDUFA report FY2025). USA 1–2 B+ A legal duty to warn, with public decisions and access to adverse-event databases. The label wording is proposed by the company. Much of the efficacy data dates from the 1960s.
MHRA Drug Safety Updates UK government regulator (funding mix not checked for this article) UK 1–2 B+ Warnings are based on Yellow Card reports, coroners' reports and independent Commission on Human Medicines advice. Regulators tend to act on harms slowly.
NHS medicine page and UK SmPC NHS (public); the SmPC is written by the licence holder (Sovereign Medical) and approved by the regulator UK 1 / 4 (SmPC) A− / B The NHS page is plain-language public information. The SmPC is company text but regulator-approved and legally binding.
Breilmann et al., Cochrane 2019 (panic) No funding. Cochrane bars commercial sponsors (policy). Germany / Italy / UK / Japan 2–3 B Rigorous methods, and the authors openly downgraded the evidence. But the trial base was almost entirely sponsored by benzodiazepine makers, and one author declared industry fees.
Amato et al., Cochrane 2010 (alcohol withdrawal) AIFA (Italian public medicines agency) Italy 1–2 B+ Publicly funded with no conflicts. The trials were very varied, so the authors could draw only limited conclusions.
Prasad et al., Cochrane 2014 (status epilepticus) Academic institutions (India, Bahrain) India / Bahrain 2 B+ Independent, but the body of randomised evidence is small.
Slee et al., Lancet 2019 (GAD network meta-analysis) No funding UK 2–3 B Large and independent, but it relies on industry-run trials. The first author later disclosed personal fees from a company (Medibio).
Friedman et al. 2017 (back pain RCT) Academic translational-research grant (Einstein/Montefiore) USA 2 B+ Double-blind and independent, with no conflicts. It was a single, small trial (114 patients).
Offidani et al. 2013 (benzodiazepines vs antidepressants) Not stated in the PubMed record Italy 3 (unverified) C+ A useful dissenting view, but it compares mainly older tricyclic antidepressants and its funding and conflicts were not verified.
AGS Beers Criteria 2023 American Geriatrics Society USA 2 A− A GRADE-style expert panel. Several members declared consulting ties to health-information companies and insurers, but none to diazepam makers.
Public Health England prescribed medicines review (2019) UK government UK 1 A− A national prescribing-data analysis. Its evidence review on how to manage withdrawal was mostly low quality.
Valium label holder (Waylis Therapeutics) and Roche historical materials Companies USA / Switzerland 4 B for regulated facts, D for promotional claims Used here only for regulated facts such as licence holder, dose and pharmacokinetics.

What diazepam is

Class and names. Diazepam is a benzodiazepine, a class of medicines the FDA describes as slowing brain activity by binding to GABA receptors (FDA). The best-known brand is Valium. In the US it is also sold as a rectal gel (Diastat) and a nasal spray (Valtoco) for seizure clusters (FDA list of benzodiazepines). In the UK it comes as 2 mg, 5 mg and 10 mg tablets and as a rectal tube, and it is usually dispensed as a generic (NHS).

History. Leo Sternbach, a chemist at Hoffmann-La Roche, identified the first benzodiazepine, chlordiazepoxide (Librium), in 1955. Roche launched Librium by 1960 and followed it with Valium in 1963. In the mid-to-late 1970s, benzodiazepines "topped all 'most frequently prescribed' lists" (Wick, Consult Pharm 2013). The FDA first approved Valium tablets (NDA 013263) on 15 November 1963 (Drugs@FDA via openFDA).

Originator. F. Hoffmann-La Roche was founded in Basel, Switzerland, in 1896 (Roche).

Generics and legal status. Diazepam has long been off-patent. openFDA lists 24 generic (ANDA) application records for diazepam (openFDA query, September 2026).

How it works

The US label describes diazepam as having "anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects". It says most of these effects are thought to come from boosting the action of GABA, the brain's main inhibitory (calming) chemical messenger (FDA label). One mechanism produces all five effects, so a person taking it for muscle spasm also gets its sedation and memory effects.

What the body does with it: why "long-acting" matters

These figures are all from the US label (FDA label).

  • Absorption: more than 90% of an oral dose is absorbed. Peak blood levels come on average 1–1.5 hours after a dose. A moderately fatty meal slows absorption to about 2.5 hours.
  • Breakdown: the liver enzymes CYP3A4 and CYP2C19 convert diazepam into active metabolites: N-desmethyldiazepam (nordazepam), temazepam and oxazepam.
  • How long it lasts: diazepam's terminal half-life is up to 48 hours. Its main active metabolite has a half-life of up to 100 hours, so diazepam builds up with repeated doses.
  • Age: the half-life rises by about 1 hour for each year of age, starting from about 20 hours at age 20.
  • Liver disease: in cirrhosis the half-life rises on average 2- to 5-fold, and individual half-lives of more than 500 hours have been reported.

This long action cuts both ways:

  • Next-day effects: the UK SmPC warns that impaired function and sedation may occur "the following morning and for several days after" (UK SmPC). Older people and people with liver disease are at particular risk of build-up.
  • Tapering: blood levels fall slowly, and that is why long-acting benzodiazepines are useful when reducing a dose. NICE's dependence guideline says that if a person is withdrawing from a benzodiazepine with a short half-life, prescribers should "consider switching to a benzodiazepine with a longer half-life" (NICE NG215, 1.5.13). NICE does not name a particular drug. Diazepam's long half-life fits that description.
  • Switching the other way: the UK SmPC warns against switching from a long-acting to a short-acting benzodiazepine, because withdrawal symptoms may develop (UK SmPC).

What it is prescribed for

Licensed uses

Use UK licence (SmPC / NHS) US licence (Valium label)
Anxiety "Short-term relief (up to 4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress", with or without insomnia Management of anxiety disorders or short-term relief of anxiety symptoms. The label adds that anxiety "associated with the stress of everyday life usually does not require treatment with an anxiolytic".
Acute alcohol withdrawal Symptomatic treatment Acute agitation, tremor, impending or acute delirium tremens, and hallucinosis
Muscle spasm and spasticity Muscle spasm, cerebral palsy, and spasticity from upper motor neurone disorders Add-on treatment for skeletal muscle spasm, spasticity from upper motor neurone disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome
Epilepsy and seizures Add-on treatment for some epilepsies (for example myoclonus). Rectal tubes are used for seizures. Add-on treatment in convulsive disorders; "not proved useful as the sole therapy"
Sedation before procedures Premedication before surgery and for nervous dental patients (Injectable and other forms; not covered by the tablet label)

Sources: UK SmPC, NHS, FDA Valium label.

Where guidelines place it

  • Generalised anxiety disorder: NICE says "Do not offer a benzodiazepine for the treatment of GAD in primary or secondary care except as a short-term measure during crises" (1.2.26). NICE's first-line options are psychological therapy and SSRIs such as sertraline (NICE CG113). Not recommended for ongoing use.
  • Panic disorder: NICE says benzodiazepines "are associated with a less good outcome in the long term and should not be prescribed" (1.3.20). Antidepressants "should be the only pharmacological intervention used in the longer-term management of panic disorder" (NICE CG113). Not recommended.
  • WHO (GAD and panic disorder): "Benzodiazepines are not recommended". Emergency use for acute, severe anxiety may be considered "only as a short-term (3–7 days maximum) measure". This is a strong recommendation based on low-certainty evidence. WHO's remarks note that diazepam was one of the benzodiazepines studied for panic disorder (WHO mhGAP 2023, ANX6).
  • Alcohol withdrawal: NICE says "Consider offering a benzodiazepine or carbamazepine", with clomethiazole as an inpatient-only alternative (NICE CG100, 1.1.3.1). A recognised first-line option.
  • Convulsive status epilepticus in the community: NICE says to give "a benzodiazepine (buccal midazolam or rectal diazepam) immediately". Buccal midazolam is the first choice, and rectal diazepam is the alternative if agreed or if midazolam is unavailable (NICE NG217). Second choice to midazolam in the community.
  • Sciatica: NICE says "Do not offer … benzodiazepines for managing sciatica as there is no overall evidence of benefit and there is evidence of harm" (NICE NG59, 1.2.16). Not recommended.
  • Dependence-forming medicines generally: before starting a benzodiazepine, NICE says to make sure all suitable options, "including non-pharmacological approaches and watchful waiting", have been discussed and offered (NICE NG215, 1.2.1). Since January 2026 the MHRA has asked prescribers to agree a plan for reducing or ending treatment before it starts (MHRA 2026).

What works and what does not

Use Verdict Why
Emergency treatment of prolonged convulsive seizures Works IV diazepam and rectal diazepam gel both beat placebo, but IV lorazepam (hospital) and buccal midazolam (community) are preferred (Cochrane 2014; NICE NG217)
Preventing seizures during alcohol withdrawal Works Seizures vs placebo RR 0.16 in a publicly funded Cochrane review (Amato 2010)
Short-term relief of severe anxiety (days to a few weeks) Works (short-term only) Works quickly and beats placebo, but tolerability is poor (Slee 2019; Cochrane 2019)
Other alcohol-withdrawal outcomes (symptom scores, delirium) Mixed Trials were too varied for firm conclusions. There are some suggestions that carbamazepine may do as well as or better than benzodiazepines on some measures (Amato 2010; Minozzi 2010)
Spasticity (cerebral palsy, spinal cord conditions) Mixed Licensed in both countries, but no independent systematic review was assessed for this article
Long-term treatment of GAD or panic disorder Insufficient / not recommended Few long-term trials. NICE and WHO recommend against. The label says effectiveness beyond 4 months has not been studied systematically (Shinfuku 2019; FDA label)
Acute low back pain or sciatica Does not work No added benefit over naproxen alone, and NICE says do not offer it for sciatica (Friedman 2017; NICE NG59)
Depression on its own Not appropriate The UK SmPC says it should not be used as the only treatment in depression, or in anxiety with depression, "as suicide may be precipitated" (UK SmPC)
Everyday stress and grief Not appropriate The US label says everyday-stress anxiety "usually does not require treatment". The UK SmPC warns that benzodiazepines may inhibit psychological adjustment after loss or bereavement (FDA label; UK SmPC)

Benefits by claim

Anxiety and panic: fast, real, short-lived and costly to tolerate

The largest independent Cochrane review of benzodiazepines for panic disorder included 24 double-blind trials with 4,233 participants (Breilmann et al., Cochrane 2019).

  • Response: RR 1.65 (95% CI 1.39–1.96), a number needed to treat of 4.
  • Remission: RR 1.61.
  • Harms: more people dropped out because of adverse effects (RR 1.58), and more had at least one adverse effect (RR 1.18).

The authors rated all of this as low-quality evidence and gave several reasons:

  • "possible unmasking of allocated treatments". Sedation makes it easy for patients and assessors to guess who is on the drug.
  • high dropout rates
  • "probable publication bias"
  • short trials that did not look at long-term effectiveness, dependence or withdrawal

Two further points matter for diazepam. Only 2 of the 24 trials used diazepam, and in both it ran alongside alprazolam, which was the drug most often tested. And the reviewers judged all but one trial to be at unclear risk of bias on funding, because they "were sponsored or supported by pharmaceutical companies marketing benzodiazepines (Hoffmann-La Roche; Upjohn, Bristol-Myers Squibb), or there was no information on study sponsoring". A subgroup analysis found no substantial differences between individual benzodiazepines.

For generalised anxiety disorder, an unfunded network meta-analysis of 89 trials with 25,441 patients found that benzodiazepines were "effective but also poorly tolerated" compared with placebo. Duloxetine, pregabalin, venlafaxine and escitalopram worked with "relatively good acceptability" (Slee et al., Lancet 2019). When benzodiazepines were compared directly with antidepressants for panic disorder, Cochrane found "no difference" in response (RR 0.99). That result rested on only 2 studies with 215 participants and low-quality evidence (Bighelli et al., Cochrane 2016).

A dissenting view. A 2013 meta-analysis from the University of Bologna argued that the shift from benzodiazepines to antidepressants "has occurred without supporting evidence". In 10 trials in panic disorder, it found benzodiazepines slightly more effective than tricyclic antidepressants at reducing panic attacks (RR 1.13) and better tolerated (Offidani et al., Psychother Psychosom 2013). Most of its comparisons were with older tricyclics rather than SSRIs, and its funding is not stated in the PubMed record. We include it because it is a serious argument, but it has not changed NICE or WHO guidance.

Long-term use. A 2019 meta-analysis found only 8 studies (N = 1,228) that lasted 13 weeks or more. HAM-A score changes did not differ significantly between benzodiazepines and placebo. The authors also found no significant differences from antidepressants in people who had responded to the first 8 weeks of treatment (Shinfuku et al. 2019).

What this means in practice. Diazepam can take the edge off acute, severe anxiety within hours. That is a real benefit in a crisis. There is little good evidence that the benefit lasts, while the risks (dependence, falls, memory effects, interactions) build up with time. For this reason WHO reached a strong recommendation against routine use despite low-certainty evidence, concluding "that the risks of the intervention outweighed the benefits" (WHO mhGAP 2023).

Alcohol withdrawal

A Cochrane review of 64 trials (4,309 participants) found that benzodiazepines protected against withdrawal seizures compared with placebo: RR 0.16 (0.04–0.69), from 3 studies with 324 people. The authors concluded that benzodiazepines showed "a protective benefit against alcohol withdrawal symptoms, in particular seizures". They also said "no definite conclusions" on overall effectiveness and safety were possible because the trials differed so much. Among the benzodiazepines, chlordiazepoxide "performed better", but this did not reach statistical significance (Amato et al., Cochrane 2010). NICE lists a benzodiazepine or carbamazepine as options (NICE CG100). Alcohol withdrawal can be dangerous, and its treatment should always be medically supervised.

Seizures and status epilepticus

In a Cochrane review of 18 trials (2,755 participants), the following all reduced the risk that seizures would not stop (Prasad et al., Cochrane 2014):

  • IV diazepam vs placebo: RR 0.73. It also reduced the need for ventilatory support (RR 0.39).
  • Diazepam gel vs placebo: RR 0.43.
  • IV lorazepam vs IV diazepam: lorazepam was better (RR 0.64).

This fits NICE's approach: IV lorazepam in hospital, and buccal midazolam or rectal diazepam in the community (NICE NG217). As an ongoing oral epilepsy treatment, the US label says diazepam "has not proved useful as the sole therapy" (FDA label).

Muscle spasm and back pain

Diazepam is licensed for muscle spasm, but the best independent trial in a common real-world use was negative. In 114 emergency-department patients with acute low back pain, adding diazepam 5 mg to naproxen gave the same improvement in disability score as adding placebo (11 points in each group). At one week, 32% of the diazepam group reported moderate or severe pain compared with 22% of the placebo group, and adverse events were 21% vs 15% (Friedman et al. 2017). NICE advises against benzodiazepines for sciatica (NICE NG59). We did not review evidence for spasticity in neurological conditions, where diazepam is still licensed.

How quickly it works

Unlike antidepressants, diazepam acts within hours. Peak blood levels come on average 1–1.5 hours after an oral dose, and later after a meal (FDA label). This speed is the reason it is used in crises. It is also part of why it is easy to keep reaching for.

Risks and all side effects

FDA boxed warning

The Valium label's boxed warning covers three risks (FDA Valium label):

  1. Use with opioids. The combination "may result in profound sedation, respiratory depression, coma, and death". Prescribers should keep co-prescribing for patients whose alternatives are inadequate, and keep doses and durations to a minimum.
  2. Abuse, misuse and addiction. These "can lead to overdose or death". Abuse often involves other medicines, alcohol or illicit drugs.
  3. Dependence and withdrawal. Continued use "may lead to clinically significant physical dependence". The risk grows with longer treatment and higher doses. Stopping suddenly or cutting the dose quickly "may precipitate acute withdrawal reactions, which can be life-threatening", so a gradual taper should be used.

The FDA added the opioid warning on 31 August 2016, after a review found that growing combined use had caused "serious side effects, including slowed or difficult breathing and deaths" (FDA 2016, archived). In September 2020 it required the dependence and addiction warning across the whole benzodiazepine class. Its review found that physical dependence "can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed", and that some patients had withdrawal symptoms "lasting many months". The FDA's data summary also reported (FDA 2020):

  • 92 million US benzodiazepine prescriptions dispensed in 2019
  • about 50% of patients given oral benzodiazepines in 2018 received them for two months or longer
  • benzodiazepine-involved overdose deaths rose from 1,298 in 2010 to 11,537 in 2017, and 55% of these deaths from 2013 to 2017 also involved prescription opioids

UK regulator warnings

  • MHRA, 18 March 2020: benzodiazepines and opioids should be prescribed together "only … if there is no alternative", at the lowest doses for the shortest time, with close monitoring. With methadone, monitoring should last at least 2 weeks after starting or changing treatment. The update followed a coroner's report of a death involving clonazepam and methadone (MHRA).
  • MHRA, 8 January 2026: after independent advice from the Commission on Human Medicines, the MHRA concluded that the existing warnings "did not sufficiently communicate the extent of the known risks of addiction, dependence, withdrawal and tolerance". It is strengthening product information and packaging. It says these effects "can also occur with short-term use at recommended therapeutic doses", and that tapering from a high dose "may take weeks or months" (MHRA 2026).

Common side effects

The NHS lists these common side effects (NHS):

  • feeling less alert
  • increased anxiety and depression
  • drowsiness
  • tiredness
  • low blood pressure

The US label says the side effects "most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia" (unsteadiness) (FDA label). The UK SmPC adds numbed emotions, confusion, headache, dizziness and double vision. These occur mainly at the start of treatment and usually fade (UK SmPC).

Other reported effects:

  • Nervous system and senses: slurred speech, tremor, vertigo, blurred vision
  • Digestive: constipation, nausea
  • Urinary and sexual: incontinence or urinary retention, changes in libido
  • Other: dry mouth or excess saliva, skin reactions

(FDA label)

Serious risks

Risk What the sources say Source
Respiratory depression, coma and death with opioids, alcohol or other sedatives The effects add together. Most benzodiazepine overdose deaths involve other drugs. MHRA; FDA
Physical dependence and withdrawal, including seizures Can develop within days to weeks, even at prescribed doses. Acute withdrawal can include anxiety, insomnia, tremor, sensitivity to sound and light, and depersonalisation. Severe reactions include seizures, delirium, psychosis and suicidality. FDA label
Protracted withdrawal syndrome Anxiety, cognitive problems, insomnia, tingling, crawling skin, tinnitus and muscle symptoms lasting beyond 4–6 weeks, and sometimes "more than 12 months" FDA label
Abuse, misuse and addiction Higher risk with a current or past substance-use disorder, including alcohol, or a mental health condition such as major depression UK SmPC; MHRA 2026
Falls and fractures, especially in older adults Reported after marketing, with higher risk alongside other sedatives, including alcohol. Beers 2023 lists cognitive impairment, delirium, falls, fractures and motor vehicle crashes. FDA label; Beers 2023
Neonatal sedation and withdrawal Use late in pregnancy can cause breathing problems, floppiness and withdrawal in the newborn FDA label; UK SmPC
Anterograde amnesia Memory gaps for events after a dose, more likely at higher doses, and sometimes linked with inappropriate behaviour UK SmPC
Paradoxical reactions Agitation, aggression, rage, hallucinations and nightmares, more likely in children and older people. The drug should be stopped if these occur. FDA label
Tolerance The effect wears off with continued use, and the person may feel they need higher doses. The hypnotic (sleep) effect fades within a few weeks. UK SmPC
Rebound anxiety and insomnia The original symptoms may come back more strongly on stopping UK SmPC
Worsening depression or suicide risk Should not be used alone in depression. Suicidal tendencies may be present in people with depression and anxiety. UK SmPC; FDA label
Allergic reactions, breathing difficulty, jaundice Rare but serious. The NHS says to call 111 or get urgent help. The label advises periodic blood counts and liver tests during long-term use. NHS; FDA label
Overdose Ranges from drowsiness to coma. It can be fatal combined with alcohol or opioids. Flumazenil can reverse sedation but can trigger seizures in dependent people. FDA label

Driving and the law

Diazepam is one of 8 "medicinal" drugs with a legal blood limit for drivers in England and Wales. The limit is 550 µg/L of blood, and the rules came into force on 2 March 2015. The government says it "is unable to provide any guidance on what amounts of dosage would equate to being over the specified limits" (Department for Transport).

You can drive above the limit only if all three of these apply (GOV.UK):

  • the medicine was prescribed for you
  • you took it as advised
  • it is not making you unfit to drive

It is illegal anywhere in the UK to drive while impaired by any drug. A conviction brings at least a 1-year ban, an unlimited fine, up to 6 months in prison and a criminal record (GOV.UK). The UK SmPC warns that effects on alertness can last into the next day, even after a single dose (UK SmPC).

How widely it is used

In England in 2017–18, 1.4 million adults (3%) had a benzodiazepine prescription dispensed. Prescription numbers "continue to fall". About 82% of people starting a benzodiazepine received prescriptions for 3 months or less, and about 5% received them continuously for at least 12 months. Some 120,000 people received benzodiazepines continuously from April 2015 to March 2018. Public Health England noted that guidelines say benzodiazepines "should not usually be prescribed for longer than 2 to 4 weeks" (PHE prescribed medicines review, 2019).

All interactions

Diazepam interacts in two ways. First, its sedative effects add to those of other drugs that slow the brain and breathing. Second, drugs that block or speed up the liver enzymes CYP3A4 and CYP2C19 raise or lower its levels. This table combines the UK SmPC (SmPC 4.5), the US label (FDA label) and the NHS page (NHS). It is not a substitute for a pharmacist's check.

Interacting substance Effect Level of concern
Opioids (codeine, tramadol, morphine, oxycodone, methadone, buprenorphine, opioid cough medicines) Additive depression of breathing. Risk of sedation, coma and death. Boxed warning: only if there is no alternative
Alcohol Stronger sedation, impaired driving, and fatal overdose in combination Avoid (NHS, SmPC, FDA)
Clozapine Severe low blood pressure, breathing depression, unconsciousness, and potentially fatal respiratory or cardiac arrest Avoid
Sodium oxybate Stronger effects of sodium oxybate Avoid
HIV protease inhibitors and some antivirals (ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, efavirenz, delavirdine) Block CYP3A4, causing prolonged sedation and breathing depression Avoid
Other sedating medicines: antipsychotics, other anxiolytics and hypnotics, sedating antihistamines, antidepressants, anticonvulsants, general anaesthetics, barbiturates, muscle relaxants (baclofen, tizanidine) Additive sedation and depression of breathing and circulation Caution; prescriber review
Fluvoxamine Blocks CYP3A4 and CYP2C19. Diazepam exposure (AUC) up by about 190%. SmPC prefers a benzodiazepine that is not metabolised this way
Fluoxetine Higher and longer-lasting diazepam levels, with more sedation Caution
Omeprazole, esomeprazole Block CYP2C19. Diazepam AUC up about 30–120%. Caution
Azole antifungals (fluconazole, voriconazole, itraconazole, ketoconazole) Fluconazole raised diazepam AUC 2.5-fold and lengthened the half-life from 31 to 73 hours Avoid or reduce the dose
Cimetidine, erythromycin, isoniazid Reduce diazepam clearance. Cimetidine raised combined diazepam and metabolite levels by 57%. Caution
Rifampicin Increases diazepam clearance about fourfold, so diazepam works less well Avoid
Carbamazepine, phenytoin, phenobarbital Speed up diazepam breakdown (carbamazepine up to three-fold clearance). Phenytoin levels may change unpredictably. Phenobarbital adds sedation. Monitor
St John's wort (Hypericum perforatum) An enzyme inducer that can substantially lower diazepam levels Tell your prescriber
Grapefruit juice Peak level up 1.5 times and exposure (AUC) up 3.2 times. The NHS says do not drink it. Avoid
Sodium valproate Displaces diazepam from protein, so it may cause more drowsiness Monitor
Blood pressure medicines, diuretics, nitrates Stronger lowering of blood pressure Monitor
Levodopa Diazepam may reduce its effect Monitor
Combined oral contraceptives May increase diazepam's effects. Breakthrough bleeding has been reported, but no contraceptive failures. Monitor
Caffeine, theophylline May reduce diazepam's sedative and anti-anxiety effects Minor
Antacids Slow absorption; peak levels about 30% lower Minor
Flumazenil (overdose antidote) Can trigger withdrawal and seizures in people dependent on benzodiazepines Hospital use only

Who should avoid diazepam

Contraindications (UK SmPC). Diazepam should not be used by people with (UK SmPC 4.3):

  • allergy to diazepam or other benzodiazepines
  • phobic or obsessional states, or chronic psychosis
  • acute pulmonary insufficiency, respiratory depression, or severe respiratory insufficiency
  • myasthenia gravis
  • sleep apnoea
  • severe liver insufficiency
  • acute porphyria
  • depression, or anxiety with depression, if diazepam would be the only treatment

It should also not be used by people planning a pregnancy or who are pregnant, unless there are compelling reasons.

Contraindications (US label). The US label adds babies under 6 months and acute narrow-angle glaucoma (FDA label).

Use with extra caution. The NHS says diazepam may not be suitable if you have (NHS):

  • long-term kidney, liver, heart or breathing problems
  • certain mental health conditions
  • a history of alcohol or recreational drug misuse

The SmPC advises "extreme caution" in people with personality disorders (UK SmPC).

Pregnancy. The NHS says not to take diazepam during pregnancy unless a doctor advises it (NHS).

  • The UK SmPC says it should not be used in the first and third trimesters. It notes a possible small increase in oral cleft risk with first-trimester benzodiazepine use, although "a causal relationship has not been established" (UK SmPC 4.6).
  • The US label says recent adjusted observational studies "do not report a clear association" with major birth defects. It warns of sedation and withdrawal in newborns after use late in pregnancy (FDA label).
  • Do not stop suddenly if you find you are pregnant. Speak to your prescriber promptly.

Breastfeeding. The sources differ in tone:

  • The US label says breastfeeding "is not recommended".
  • The UK SmPC says benzodiazepines "should not be given to breast-feeding mothers".
  • The NHS says to check with a pharmacist or doctor. Short, low-dose use may be advised if the benefits outweigh the risks.

Sedation and poor feeding have been reported in exposed infants (FDA label; UK SmPC; NHS).

Older adults. The 2023 AGS Beers Criteria list diazepam among the benzodiazepines to avoid. They note that "older adults have increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents". They also say "shorter-acting ones are not safer than long-acting ones" for falls (AGS Beers 2023). If an older person is prescribed diazepam:

  • The US label advises starting at 2–2.5 mg once or twice a day, and notes "extensive accumulation" with long-term use (FDA label).
  • The UK SmPC halves the usual doses (UK SmPC).

Liver and kidney disease. In liver impairment, diazepam "may precipitate coma", so the dose should be reduced or another drug considered. Severe liver insufficiency is a contraindication. In severe kidney impairment the dose should be reduced (UK SmPC).

Children. Children have their own licensed uses and doses under specialist direction. This article covers adults.

Dosage and how to take it

Your prescriber sets the dose and how long you take it. The ranges below are the official licensed adult ranges, reproduced for information only. They are not a guide to self-dosing.

Indication (adults) UK SmPC US Valium label
Anxiety 5–30 mg daily in divided doses; lowest effective dose; not beyond 4 weeks 2–10 mg, 2 to 4 times daily depending on severity
Insomnia associated with anxiety 5–15 mg before bedtime (not listed)
Acute alcohol withdrawal 5–20 mg, repeated if necessary in 2–4 hours 10 mg 3 or 4 times in the first 24 hours, then 5 mg 3 or 4 times daily as needed
Muscle spasm 5–15 mg daily in divided doses (up to 60 mg daily for cerebral palsy and upper motor neurone spasticity) 2–10 mg, 3 or 4 times daily
Add-on treatment for epilepsy 2–60 mg daily in divided doses 2–10 mg, 2 to 4 times daily
Older or debilitated adults Half the doses above 2–2.5 mg once or twice daily at first, increased gradually

Sources: UK SmPC 4.2; FDA Valium label.

How long. The NHS says up to 4 weeks (NHS). The UK SmPC says the patient must be re-evaluated after no more than 4 weeks. "In general, treatment must not last any longer than 8-12 weeks, including the tapering off process", with longer use only after a fresh evaluation. Epilepsy is an exception, where the drug is used "for as long as the prescriber considers it necessary" (UK SmPC). Before starting, the prescriber should agree a plan for ending treatment with you (MHRA 2026).

How to take it. The NHS gives this advice (NHS):

  • Swallow tablets whole with water, with or without food. Doses can be spread through the day.
  • If you miss a dose, skip it. Never double up.
  • Rectal tubes are single-use. If seizures do not stop, a second dose can usually be given after 10 minutes, as directed.

How it is stopped. After regular use, diazepam should be reduced gradually and only with your prescriber (NHS). The official guidance says:

  • "No standard benzodiazepine tapering schedule is suitable for all patients". The plan should be patient-specific, with monitoring and support (FDA 2020).
  • If withdrawal reactions develop, pause the taper or go back to the previous dose, then reduce more slowly (FDA label).
  • Reduce in slow steps "proportionate to the existing dose, so that decrements become smaller as the dose is lowered". Tapering from a high dose "may take in excess of weeks or months" (UK SmPC).
  • Do not stop abruptly except in exceptional medical circumstances. For people on a short half-life benzodiazepine, consider switching to a longer-acting one. Keep treating the underlying condition during withdrawal (NICE NG215).

Follow the money: who makes it and who funded the evidence

Who makes and sells it

  • Originator: F. Hoffmann-La Roche, founded in Basel, Switzerland, in 1896 (Roche). Roche's chemist Leo Sternbach discovered the benzodiazepine class, and Roche launched Valium in 1963 (Wick 2013).
  • US licence today: openFDA lists the original Valium tablet application (NDA 013263, approved 15 November 1963) under Waylis Therapeutics. The August 2024 label says "Distributed by: Waylis Therapeutics LLC, Rahway, NJ". Roche's separate Valium injection application (NDA 016087, 1966) is listed as discontinued (Drugs@FDA via openFDA; DailyMed). DailyMed also still lists a separate Valium tablet label under Roche Laboratories Inc. (published 10 December 2025) (DailyMed Valium listings). We could not verify when or on what terms the US rights moved from Roche, or who owns Waylis.
  • Canada: Roche still holds the Valium product monograph, with Hoffmann-La Roche Ltd, Mississauga, as sponsor (revised June 2021) (Roche Canada monograph).
  • UK: diazepam is supplied mainly as generics. For example, the SmPC used in this article belongs to Waymade plc, trading as Sovereign Medical, of Basildon, England (UK SmPC).
  • Generics: openFDA lists 24 generic (ANDA) application records for diazepam in the US (openFDA). With so many generic makers, no single company has a large commercial stake in diazepam tablets today.
  • Revenue: we found no current published sales figure for Valium or generic diazepam.

Who funded the evidence

Manufacturer-generated evidence. Valium was approved in 1963. We could not find the original registration trials in public sources.

  • The modern US label says that effectiveness beyond 4 months "has not been assessed by systematic clinical studies" (FDA label).
  • In the Cochrane panic review, the reviewers judged all but one trial to be at unclear risk of bias on funding. The reason was that the trials were sponsored or supported by benzodiazepine makers, namely Hoffmann-La Roche, Upjohn (maker of alprazolam) and Bristol-Myers Squibb, or did not say who sponsored them (Breilmann 2019).
  • The reviewers planned sensitivity analyses excluding company-funded trials. They explained that "funding strongly affects outcomes of research studies".

Independent evidence. The reviews that carry the most weight in this article were paid for by public bodies or had no funding:

  • Cochrane panic review (Breilmann 2019): no internal or external funding. One author declared lecture and consultancy fees from several drug companies, none of them diazepam makers (Breilmann 2019).
  • Cochrane alcohol-withdrawal review (Amato 2010): funded by AIFA, Italy's public medicines regulator, with no conflicts (Amato 2010, sources of support).
  • Cochrane status-epilepticus review (Prasad 2014): academic institutions in India and Bahrain, with no conflicts known (Prasad 2014).
  • Slee 2019 GAD network meta-analysis: "No funding was received" (Slee 2019).
  • Friedman 2017 back-pain trial: an academic clinical-research grant, with no conflicts (Friedman 2017).

These reviews still depend on trials that were largely run by manufacturers.

Who pays the regulators. The regulators whose warnings we rely on are publicly accountable but not free of industry money. About 77% of the FDA's human-drug review costs in FY2025 came from industry user fees (FDA PDUFA financial report). NICE receives about 70% of its funding from government, and some fees from companies for technology appraisals (NICE accounts). For an old generic like diazepam, the incentives mostly point towards caution rather than promotion. No company has a strong commercial reason to defend it.

Integrity events. We found no documented fraud, settlement or data-suppression case involving diazepam in the sources reviewed. The main historical concern is the scale of use. In the 1970s, benzodiazepines topped "most frequently prescribed" lists, and "by the 1980s … the specter of abuse and dependence" had emerged (Wick 2013). The FDA's 2020 and MHRA's 2026 decisions to strengthen warnings, decades after launch, show how slowly the understanding of dependence caught up with prescribing.

Frequently asked questions

How long does diazepam take to work?

Quickly. After a tablet, blood levels peak on average 1–1.5 hours later (range 0.25–2.5 hours). Taking it with a fatty meal delays the peak to about 2.5 hours (FDA label). This fast effect is why it is used in crises. It is also why guidelines limit it to short courses (NICE CG113).

How long does diazepam stay in your system?

A long time. Diazepam's elimination half-life is up to 48 hours, and its active metabolite's is up to 100 hours. Half-lives are longer in older people (about 1 hour more for each year of age) and much longer in liver disease (FDA label). The UK product information warns that drowsiness and impaired function may continue "the following morning and for several days after" (UK SmPC).

Can you drink alcohol on diazepam?

No. The NHS says, "Do not drink alcohol or grapefruit juice while taking diazepam" (NHS). The FDA says alcohol "can increase the risk of serious and life-threatening side effects" (FDA). Alcohol adds to diazepam's sedation and its effect on breathing, and deaths from benzodiazepine overdose usually involve other substances.

Is diazepam addictive?

It can be. The FDA says physical dependence can develop when benzodiazepines are taken steadily "for several days to weeks, even as prescribed", and that abuse and addiction can occur even at recommended doses (FDA 2020). The MHRA says dependence and addiction can occur "with short-term use at recommended therapeutic doses". The risk is higher for people with a past or current substance-use disorder or a mental health condition such as major depression (MHRA 2026). Dependence is an expected effect of the medicine, not a personal failing. NICE asks clinicians to avoid language that blames the person (NICE NG215).

How do I stop diazepam safely?

Only with your prescriber, and gradually if you have taken it regularly. Stopping suddenly can cause withdrawal reactions, including seizures (FDA label). Official guidance calls for a personal tapering plan, with steps that get smaller as the dose falls. It advises pausing or going back a step if withdrawal symptoms become hard to bear. Coming off a high dose can take weeks to months (UK SmPC; NICE NG215). A minority of people get protracted symptoms, which can last more than 12 months (FDA label).

Why is diazepam used to come off other benzodiazepines?

Because it acts for a long time. NICE advises that people withdrawing from a short half-life benzodiazepine could consider switching to one with a longer half-life (NICE NG215). Diazepam and its active metabolite have half-lives of up to 48 and 100 hours (FDA label), so blood levels fall more smoothly between doses and during reductions. NICE does not name a specific drug, and any switch or taper plan should be set by your prescriber.

Can I drive while taking diazepam?

Not if you feel sleepy or your driving is affected (NHS). In England and Wales there is a legal blood limit for diazepam of 550 µg/L (Department for Transport). You have a legal defence if it was prescribed, you took it as instructed, and it was not impairing you (GOV.UK). Driving while impaired is illegal whatever your blood level.

Is diazepam safe for older people?

The AGS Beers Criteria advise avoiding all benzodiazepines, including diazepam, in adults aged 65 and over. The reasons they give are cognitive impairment, delirium, falls, fractures and motor vehicle crashes (AGS Beers 2023). If it is used, labels advise much lower starting doses because the drug builds up (FDA label; UK SmPC). Older people who have taken it for a long time should not stop suddenly. Any reduction should be planned with their prescriber.

Sources and funding notes

Last reviewed: 26 September 2026. Educational information from Pure City Research, not medical advice. Medicine decisions belong with a qualified prescriber.

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