temazepam (Restoril)

the boxed warning, part one: opioids

the first part says that using benzodiazepines with opioids "may result in profound sedation, respiratory depression, coma, and death", that the combination should be reserved for "patients for whom alternative treatment options are inadequate", at the minimum doses and durations, with the patient followed for slowed breathing and sedation [label, boxed warning]. the warnings section adds that "observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug related mortality compared to use of opioids alone", and that in someone already on an opioid the starting dose of temazepam should be lower than usual, and the other way round [label, warnings]. the two add rather than overlap because benzodiazepines act at gaba-a sites and opioids mainly at mu receptors [label, drug interactions].

the numbers behind it are observational and come from the whole class. among 315,428 insured american adults who filled an opioid prescription between 2001 and 2013, the share also filling a benzodiazepine rose from 9% to 17%, and those taking both had about twice the odds (adjusted odds ratio 2.14) of an emergency visit or admission for opioid overdose [sun-2017]. across 399,230 us opioid overdose deaths from 1999 to 2017, benzodiazepine involvement rose from 8.7% to 21.0%, and a benzodiazepine was present in 33.1% of prescription-opioid deaths in 2017 [tori-2020]. in cdc surveillance for the first half of 2018, 62.6% of opioid deaths in 25 states also involved cocaine, methamphetamine or a benzodiazepine [gladden-2019]. none of these names temazepam or proves the benzodiazepine caused the deaths; all of them count the class there.

the boxed warning, parts two and three: abuse, misuse and addiction; dependence and withdrawal

the second part says benzodiazepines, "including temazepam", expose users to "risks of abuse, misuse, and addiction, which can lead to overdose or death", that abuse and misuse "commonly involve concomitant use of other medications, alcohol, and/or illicit substances", and that each patient’s risk should be assessed before prescribing and throughout treatment [label, boxed warning]. the label adds that "even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication", and that death "is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol)" [label, drug abuse and dependence].

the third part says continued use "may lead to clinically significant physical dependence", that the risks "increase with longer treatment duration and higher daily dose", and that abrupt discontinuation or rapid dose reduction "may precipitate acute withdrawal reactions, which can be life-threatening" [label, boxed warning]. the fda required this wording on every benzodiazepine in september 2020, and its point is that dependence can develop when the drug is taken exactly as prescribed, which is a reason not to stop on one’s own [fda-2020]. the label’s acute withdrawal list runs from anxiety, insomnia, tremor, racing heart, panic attacks and sensitivity to light and sound to catatonia, convulsions, delirium tremens, hallucinations, mania, psychosis, seizures and suicidality. a protracted syndrome of anxiety, cognitive impairment, depression, insomnia, crawling-skin sensations, tremor, tingling and tinnitus can persist beyond four to six weeks and "may last weeks to more than 12 months", and the label concedes it can be hard to tell from "re-emergence or continuation of symptoms for which the benzodiazepine was being used" [label, drug abuse and dependence]. for a sleeping pill, that last sentence means the returning insomnia can itself be withdrawal.

on tolerance: "tolerance to the therapeutic effect of temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines" [label, drug abuse and dependence]. the efficacy section, separately, reports no loss of effect in the sleep laboratory "for at least 2 weeks", which is as long as its trials ran [label, clinical pharmacology].

what the label says about tapering, and about the 7 to 10 days

quoted so that it is the label’s and not ours: "to reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly" [label, dosage and administration]. the warnings section adds that "a patient-specific plan should be used to taper the dose", with the greatest risk in people on higher doses and longer use [label, warnings]. it gives no step size or schedule. the uk guideline on these medicines says to taper in steps proportionate to the current dose and to expect that withdrawal "may take several months or more" [nice-2022]. a cochrane review of 38 trials in 2,543 long-term benzodiazepine users found no add-on medication that reliably made stopping easier [baandrup-2018].

the label’s duration language is stronger than most. besides the 7 to 10 day indication, it says "the failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated", and that a decision to treat insomnia with a drug "should only be made after the patient has been carefully evaluated", because sleep disturbance "may be the presenting manifestation of an underlying physical and/or psychiatric disorder" [label, warnings]. the usual dose is 15 mg at bedtime, within 7.5 to 30 mg, and 7.5 mg to start in older or debilitated people [label, dosage and administration].

sleep-driving and the other warnings, in plain words

beyond the boxed warning, the warnings and precautions sections carry:

• complex sleep behaviors: "complex behaviors such as ‘sleep-driving’ (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported", in first-time and experienced users, more likely with alcohol, other depressants or doses above the maximum; "discontinuation of temazepam should be strongly considered for patients who report a ‘sleep-driving’ episode". preparing and eating food, making phone calls and having sex while not fully awake have also been reported, usually with no memory of them [label, warnings; information for patients]. this is a warning on temazepam’s label, not a boxed warning: the fda’s april 2019 boxed warning and contraindication for complex sleep behaviors applies to zolpidem, eszopiclone and zaleplon only [fda-2019; zolpidem-explainer].
• behavior and mood: decreased inhibition "similar to that seen with alcohol", bizarre behavior, agitation, hallucinations and depersonalization; amnesia "may occur unpredictably"; and "in primarily depressed patients, worsening of depression, including suicidal thinking has been reported" [label, warnings]. it should be given with caution where there is any sign of depression, "it should be recognized that suicidal tendencies may be present" [label, precautions].
• falls: temazepam "can cause drowsiness and a decreased level of consciousness", so people, "particularly the elderly, are at higher risk of falls" [label, warnings]. the trials did not include enough people over 65 to tell whether they respond differently, and the label recommends 7.5 mg as the starting dose at 65 and over because oversedation, dizziness, confusion, unsteadiness and falls rise "substantially" with larger doses [label, geriatric use].
• allergic reactions: rare angioedema of the tongue, throat or larynx after the first or later doses, which can block the airway and be fatal; anyone who has it "should not be rechallenged with the drug" [label, warnings].
• newborns: use late in pregnancy can leave a baby sedated (slow breathing, lethargy, floppiness) or in withdrawal (overactive reflexes, irritability, tremors, inconsolable crying, feeding difficulties). published observational studies "do not report a clear association" with major birth defects [label, warnings; pregnancy]. temazepam is present in breast milk, with reports of sedation, poor feeding and poor weight gain in exposed infants [label, nursing mothers].
• diphenhydramine: "the possibility of a synergistic effect exists" with the antihistamine in many over-the-counter sleep aids; one stillbirth at term was reported 8 hours after a pregnant patient took both, and "a cause and effect relationship has not yet been determined" [label, precautions]. the label points to a contraindications section for this, but this version of the label has none.
• everything else that sedates: alcohol, barbiturates, antipsychotics, other sleeping pills, anxiety drugs, antidepressants, opioid painkillers, sedating antihistamines, anticonvulsants and anaesthetics all add to its effect [label, drug interactions]. cimetidine does not change its levels [label, drug interactions]. caution with kidney, liver or chronic lung disease [label, precautions].

what the label says about its own trials

the label describes two kinds of placebo-controlled sleep-laboratory study and gives no count of trials and no per-trial numbers [label, clinical pharmacology; approval]. in people with chronic insomnia, given 7.5, 15 or 30 mg half an hour before bed for 2 weeks, total sleep time and time to fall asleep improved with dose, but at 2 weeks the difference from placebo was significant "only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose" [label, clinical pharmacology]. so in chronic insomnia, the usual 15 mg dose did not shorten the time to fall asleep more than placebo at the end of the trials, and 7.5 mg separated on neither measure. in healthy volunteers with first-night insomnia in the laboratory, time to fall asleep improved at all three doses, total sleep time at 15 and 30 mg, and night waking only at 30 mg [label, clinical pharmacology].

the label says rem sleep was "essentially unchanged and slow wave sleep was decreased", that no effect on daytime alertness or performance was measured, and that "a transient sleep disturbance in some sleep parameters was observed following withdrawal of the higher doses", which is rebound insomnia in the label’s words [label, clinical pharmacology]. it also says hangover was "essentially absent", while its own side-effect table reports "hangover" in 2.5% on temazepam against 1.1% on placebo [label, clinical pharmacology; adverse reactions]. the drug peaks about 1.5 hours after a 30 mg dose, its terminal half-life ranges from 3.5 to 18.4 hours (mean 8.8), it has no active metabolites, and after a week of nightly 30 mg doses an average of 75 ng/ml (standard deviation 80) was still in the blood at 24 hours [label, clinical pharmacology]. nothing in the label measures use beyond two weeks.

side effects, with the label’s numbers

in controlled studies in which 1,076 people took temazepam at bedtime and 783 took placebo, the label prints every reaction at 1% or more, including the ones where placebo was higher [label, adverse reactions]. higher on temazepam: drowsiness 9.1% against 5.6%, lethargy 4.5% against 3.4%, dizziness 4.5% against 3.3%, hangover 2.5% against 1.1%, euphoria 1.5% against 0.4%, confusion 1.3% against 0.5%, weakness 1.4% against 0.9%, diarrhea 1.7% against 1.1% and vertigo 1.2% against 0.8%. higher on placebo: headache 8.5% against 9.1%, nervousness 4.6% against 8.2%, nausea 3.1% against 3.8% and nightmares 1.2% against 1.7% [label, adverse reactions]. the label does not say how long those studies ran or at what doses, or whether they are the sleep-laboratory trials [label, adverse reactions].

less often (0.5% to 0.9%): loss of appetite, unsteadiness, loss of balance, tremor, more dreaming, breathlessness, palpitations, vomiting, backache, sweating and burning eyes; rarely (under 0.5%): amnesia, hallucinations and paradoxical restlessness, overstimulation and agitation [label, adverse reactions]. abnormal liver tests and blood disorders have been reported with benzodiazepines [label, laboratory tests]. in overdose the picture runs from drowsiness to coma, and overdose with alcohol or opioids "may be fatal" [label, overdosage].

what the research says, in both directions

this site’s library holds no row tagged temazepam yet. everything in this block is benzodiazepine class evidence or a guideline, labelled as such.

in favour. the american academy of sleep medicine’s 2017 guideline, after a graded review of randomised trials, says "we suggest that clinicians use temazepam as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults", a weak recommendation [aasm-2017]. the largest network meta-analysis of insomnia drugs, 154 double-blind trials in 44,089 adults, found benzodiazepines as a class more effective than placebo for short-term treatment (high to moderate certainty) and more effective than melatonin, ramelteon and zaleplon (moderate to very low certainty), with fewer dropouts for any cause than ramelteon for the intermediate-acting group [de-crescenzo-2022]. the label’s own sleep-laboratory trials show a dose-related effect on total sleep time at 15 and 30 mg over two weeks [label, clinical pharmacology].

against, or smaller than it sounds. the same network meta-analysis found benzodiazepines worse than placebo for the number of people with side effects, and concluded that licensed drugs "including benzodiazepines" can work acutely "but are associated with poor tolerability, or information about long-term effects is not available" [de-crescenzo-2022]. the aasm recommendation is graded weak, which reflects low certainty in the evidence [aasm-2017]. the label’s trials ran two weeks, the usual 15 mg dose did not shorten time to fall asleep in chronic insomnia, and the indication is 7 to 10 days, so the label offers no trial evidence on the longer use that its dependence warning says raises the risk [label, indications; clinical pharmacology; boxed warning]. a meta-analysis of 13 observational studies of long-term benzodiazepine users, about 10 years of use, found them scoring moderately worse than controls across every cognitive domain tested (effect size 0.74) [barker-2004].

the warnings, measured. the opioid warning’s size is in the three studies above [sun-2017; tori-2020; gladden-2019]. on dementia, the two best class studies point in opposite directions: a case-control study of 1,796 older adults with alzheimer’s disease found past benzodiazepine use associated with higher risk, rising with cumulative use [billioti-2014], while a prospective cohort of 3,434 adults aged 65 and over followed for 7.3 years found no increased dementia risk in the heaviest users [gray-2016]. neither is specific to temazepam.

questions people ask

what does the restoril (temazepam) black box warning mean?

it has three parts, rewritten by the fda for every benzodiazepine in september 2020. first, taking a benzodiazepine with an opioid can cause profound sedation, slowed breathing, coma and death, so the combination is for people with no adequate alternative, at the lowest doses for the shortest time. second, benzodiazepines including temazepam carry risks of abuse, misuse and addiction that can lead to overdose or death. third, continued use can cause physical dependence, and stopping abruptly or cutting the dose quickly can cause withdrawal reactions that can be life-threatening, so the dose should come down by a gradual taper. it is a warning about how the drug is used, not an instruction to stop it.

how long can you take temazepam?

the label approves it for "the short-term treatment of insomnia (generally 7 to 10 days)", says prescriptions should indicate 7 to 10 days, and says the trials supporting it lasted 2 weeks. it adds that insomnia that has not settled after 7 to 10 days may signal a medical or psychiatric illness that should be evaluated. it does not measure use beyond two weeks. for anyone who has taken it longer, the label says abrupt stopping can cause dangerous withdrawal and calls for a gradual taper, which makes any change a conversation with a prescriber.

does temazepam cause sleep-driving?

the label says sleep-driving, driving while not fully awake with no memory of it, has been reported, as have eating, making calls and having sex while not fully awake, and that the risk rises with alcohol, other depressants and doses above the maximum. it says stopping temazepam should be strongly considered after a sleep-driving episode. unlike zolpidem, eszopiclone and zaleplon, temazepam does not carry the fda’s 2019 boxed warning for these behaviors; on its label they are a standard warning.

is temazepam addictive?

it is a schedule iv controlled substance, and its label says benzodiazepines including temazepam expose users to risks of abuse, misuse and addiction, that even taking them as prescribed may put people at risk, and that continued use can cause physical dependence, with the risk rising with dose and duration. dependence means withdrawal on stopping, which the label says can be life-threatening and can last more than a year. that is why the label says to taper rather than stop.

what are the most common temazepam side effects?

in the label’s controlled studies of 1,076 people on temazepam and 783 on placebo: drowsiness 9.1% against 5.6%, dizziness 4.5% against 3.3%, lethargy 4.5% against 3.4%, hangover 2.5% against 1.1%, euphoria 1.5% against 0.4% and confusion 1.3% against 0.5%. headache and nervousness were more common on placebo. the label also warns of amnesia, worsening depression, falls in older people and, rarely, severe allergic swelling of the throat.

what is the difference between temazepam and zolpidem?

both are approved for insomnia. temazepam is a benzodiazepine, approved in 1981 for 7 to 10 days of use, and carries the 2020 benzodiazepine boxed warning on opioids, addiction and withdrawal. zolpidem is a z-drug, not a benzodiazepine, and since 2019 carries a boxed warning and contraindication for complex sleep behaviors such as sleep-driving, which temazepam lists only as a standard warning. the comparison page on this site sets the two labels side by side.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

1. temazepam capsules prescribing information, fda label on dailymed (set id 8f54731f-c5b7-492c-acb0-444c5fbb7029, version 23, effective august 5, 2026; ascend laboratories, anda 071456 and 071457): boxed warning; indications and usage; clinical pharmacology, including controlled trials supporting efficacy; warnings; precautions, including information for patients, laboratory tests, drug interactions, pregnancy, nursing mothers, pediatric and geriatric use; adverse reactions; drug abuse and dependence; overdosage; dosage and administration
2. drugs@fda, nda 018163 (restoril), approved february 27, 1981 as a new molecular entity; no fda review of the original application is published, as for most approvals of that era
3. ahrq medical expenditure panel survey, prescribed medicines public-use file 2018 (hc-206a): people with at least one temazepam purchase (694,970, standard error 112,159) and prescriptions (3,173,562, standard error 616,546), weighted; 2019 to 2021 and 2024 under ahrq’s 60 respondents, 2022 and 2023 masked; computed by veisund, method on the usage section of this page
4. fda drug safety communication, september 2020: fda requiring boxed warning updated to improve safe use of benzodiazepine drug class (library row)
5. fda drug safety communication, april 2019: certain prescription insomnia medicines, new boxed warning due to risk of serious injuries caused by sleepwalking, sleep driving and engaging in other activities while not fully awake (zolpidem, eszopiclone, zaleplon) (library row)
6. sun ec, et al. association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. bmj 2017 (benzodiazepine class) (library row)
7. tori me, larochelle mr, naimi ts. alcohol or benzodiazepine co-involvement with opioid overdose deaths in the united states, 1999 to 2017. jama network open 2020 (benzodiazepine class) (library row)
8. gladden rm, et al. changes in opioid-involved overdose deaths by opioid type and presence of benzodiazepines, cocaine, and methamphetamine, 25 states, 2017 to 2018. mmwr 2019 (benzodiazepine class) (library row)
9. national institute for health and care excellence. medicines associated with dependence or withdrawal symptoms (ng215), 2022 (library row)
10. baandrup l, et al. pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. cochrane database of systematic reviews 2018 (benzodiazepine class) (library row)
11. barker mj, et al. cognitive effects of long-term benzodiazepine use: a meta-analysis. cns drugs 2004 (benzodiazepine class) (library row)
12. billioti de gage s, et al. benzodiazepine use and risk of alzheimer’s disease: case-control study. bmj 2014 (a benzodiazepine class study, not temazepam-specific) (library row)
13. gray sl, et al. benzodiazepine use and risk of incident dementia or cognitive decline: prospective population based study. bmj 2016 (a benzodiazepine class study, not temazepam-specific) (library row)
14. de crescenzo f, et al. comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis. lancet 2022 (the library row is written up for zolpidem; the benzodiazepine class findings were read from the pubmed abstract, 35843245, on 2026-10-13) (library row)
15. sateia mj, et al. clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an american academy of sleep medicine clinical practice guideline. journal of clinical sleep medicine 2017 (the library row is written up for melatonin; the temazepam recommendation was read from the abstract, pmc5263087, on 2026-10-13) (library row)
16. what the zolpidem (ambien) warnings mean, the companion explainer on this site, with the 2019 complex sleep behaviors boxed warning
17. what the lorazepam (ativan) warnings mean, the companion explainer on this site, with the same 2020 benzodiazepine boxed warning
18. temazepam vs zolpidem, the side-by-side comparison page on this site

Most-reported reactions

• Fatigue2,835
• Drug ineffective2,454
• Nausea2,441
• Pain2,315
• Headache2,296
• Toxicity to various agents2,176
• Diarrhoea1,823
• Dyspnoea1,780
• Death1,696
• Insomnia1,691