Restoril (temazepam) vs Ambien (zolpidem)
Restoril and Ambien, compared on what the public record actually supports: side effects by rate from each FDA label, what the largest trial comparison found, who takes each one, who pays, what the labels warn, and what the litigation record holds. Sources on every number.
the short answer
- is Restoril or Ambien more effective? there is no head-to-head trial record in our library that settles this pair, and we do not fill the gap with a guess. what can be compared is below: each label's own side-effect table, who takes each drug, who pays, and the legal record.
- which has fewer side effects? the labels say their trials “cannot be directly compared”, because each drug was tested in different people under different rules. what each label prints: Restoril (temazepam): the label prints no discontinuation rate in the section we transcribed. Ambien (zolpidem): the label prints no discontinuation rate in the section we transcribed. the reactions both labels list, side by side, are in the table below.
- which should i take? not a question this page answers. the odds ratios are averages across thousands of strangers; your history, other medications and what you can live with are not in them. the questions for your prescriber below are built from what is on this page.
What this page will not do is rank them. These drugs are in different classes and were tested for partly different things, so a single-axis ranking would be a category error. Which one fits you turns on your history, your other medications, and side-effect trade-offs — a prescriber conversation. This page arms that conversation; here are the questions worth taking into it →
side effects by rate: what each label prints, not a head-to-head trial
the labels' own warning, first: “The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions.” the two columns below come from different trials, in different people, under different inclusion rules. read each against its own placebo column, not against the other drug.
| reaction | Restoril % incidence (n=1076) vs Placebo % incidence (n=783) | Zolpidem (≤10 mg) (N=152) vs Placebo (N=161) |
|---|---|---|
| dry mouth | 1.7% vs 2.2% | 3% vs 1% |
| diarrhea | 1.7% vs 1.1% | 3% vs 2% |
| somnolence | 9.1% vs 5.6% | 8% vs 5% |
| dizziness | 4.5% vs 3.3% | 5% vs 1% |
- Restoril (temazepam): the label prints no discontinuation rate in the section we transcribed.
- Ambien (zolpidem): the label prints no discontinuation rate in the section we transcribed.
what makes each table, in the labels' words
- Restoril (temazepam), SPL version 25, effective 2026-06-09, ADVERSE REACTIONS (old-format label), capsules, USP — 7.5 mg / 15 mg / 22.5 mg / 30 mg (Schedule IV controlled substance). inclusion rule: “During controlled clinical studies in which 1076 patients received Restoril at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table. (This basis statement is the label's de facto inclusion rule — the table has no caption or table number.)” trials: “The label says "controlled clinical studies" and prints a placebo column (n=783), so this is a controlled comparison; but the studies are not identified, and durations/doses are not stated in the ADVERSE REACTIONS section. The efficacy section describes 2-week placebo-controlled sleep-laboratory studies at 7.5, 15, and 30 mg and 24-hour transient-insomnia studies, but the label does not say whether the AR table's studies (n=1076/783) are those same studies — no linkage is stated, and the AR Ns are far larger than a sleep-lab program implies. Recorded as printed, unlinked.” DailyMed
- Ambien (zolpidem), SPL effective 2025-04-15, 6 ADVERSE REACTIONS / 6.1 Clinical Trials Experience, immediate-release film-coated tablets (Schedule IV controlled substance). inclusion rule: “The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials.” trials: “The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.” DailyMed
every row above was transcribed from the current FDA label on 2026-09-08; the full tables, including the reactions only one label lists, are on side-effect rates, drug vs placebo. the sexual side-effect rows carry each label's own underreporting caveat on the SSRI sexual side effects page.
temazepam (Restoril)
benzodiazepine hypnotic
- FDA approval
- 1981 · full approval journey →
- Who takes it (US, 2018)
- 694,970 patients · 3,173,562 prescriptions (AHRQ MEPS)The latest year shown is 2018: only 35 survey respondents reported it in 2024, under the 60 AHRQ requires.Correction (29 September 2026): An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves. It showed 560,526 people and 3,020,872 prescriptions for 2024, a year that does not meet AHRQ’s reliability rule; the latest year that does is 2018. It said prescriptions were down 37% since 2014; too few years meet the rule to show a trend, so that line is removed.
- Who pays (2024)
- Medicare: 2,218,229 claims · 373,635 beneficiariesMedicaid: ≥347,099 prescriptionsCommercial claims: not published in any public dataset — a real absence, not a zero.
- Boxed warning
- Yes — on the current FDA label. read it in context →
- Adverse-event reports (FAERS)
- Caveat first: FAERS counts unverified REPORTS, not patients or rates — no denominator, and attention inflates reporting. Never compare these counts head-to-head; a longer-marketed, more-prescribed drug accumulates more reports by exposure alone. how to read FAERS →37,478 all-time reports; most-reported terms: fatigue, drug ineffective, nausea
- Legal & safety record
- no dedicated record page yet; the journey page carries label history
zolpidem (Ambien)
Z-drug hypnotic
- FDA approval
- 1992 · full approval journey →
- Who takes it (US, 2024)
- 2,420,368 patients · 12,744,221 prescriptions (AHRQ MEPS)2014 → 2024: 22,399,741 → 12,744,221 prescriptions, down 43%Correction (29 September 2026): An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves.
- Who pays (2024)
- Medicare: 7,937,736 claims · 1,562,877 beneficiariesMedicaid: ≥1,613,371 prescriptionsCommercial claims: not published in any public dataset — a real absence, not a zero.
- Boxed warning
- Yes — on the current FDA label. read it in context →
- Adverse-event reports (FAERS)
- Caveat first: FAERS counts unverified REPORTS, not patients or rates — no denominator, and attention inflates reporting. Never compare these counts head-to-head; a longer-marketed, more-prescribed drug accumulates more reports by exposure alone. how to read FAERS →134,360 all-time reports; most-reported terms: drug ineffective, nausea, fatigue
- Legal & safety record
- no dedicated record page yet; the journey page carries label history
questions for your prescriber, built from this page
this page does not tell you to start, stop or switch anything. it arms the conversation where that decision belongs. take these in:
- which of Restoril and Ambien did you have in mind first, and what in my history points that way?
- these two are different classes (benzodiazepine hypnotic; Z-drug hypnotic). what are they each being asked to do for me, and is that use on the label or off it?
- the label lists these reactions above placebo for the one you're suggesting. which of them should i expect in the first weeks, and which would make you want to hear from me the same day?
- how long were the approval trials, and what do we know past that point?
- how will we judge whether it is working, by when, and what is the plan if it isn't?
- if i ever want to come off it, how is that done, and over how long?
- is there a cheaper generic or a formulation that changes the dosing, and does my insurance prefer one of these two?
the longer checklist, for any antidepressant, is questions to ask before starting antidepressants. if you are already on one and it feels like it stopped working, that has its own page.
What the warnings mean, drug by drug
Each explainer reads one drug's current FDA label and the studies in our library, in both directions: the boxed warnings with the label's own numbers, the trials behind the approval and how long they ran, side effects by rate, and the research since.
Questions people search
Is Restoril or Ambien better?
No honest page can answer that in one line. Head-to-head differences between comparable psychiatric medications are usually smaller than rankings suggest, and which fits you depends on your history, other medications, and side-effect trade-offs, a prescriber conversation. What can be compared is the public record (usage, payers, label warnings, approval history, litigation), which is what this page does, with sources.
Is Restoril the same as temazepam, and Ambien the same as zolpidem?
Restoril is a brand name for temazepam. Ambien is a brand name for zolpidem. temazepam is a benzodiazepine hypnotic; zolpidem is a Z-drug hypnotic. This page uses the generic names because the federal datasets do.
Which has fewer side effects, Restoril or Ambien?
The two FDA labels cannot be compared head to head, in their own words, because each drug's trials ran in different people under different rules. What each label prints: Restoril (temazepam): the label prints no discontinuation rate in the section we transcribed. Ambien (zolpidem): the label prints no discontinuation rate in the section we transcribed. The page shows the reactions both labels list, each against its own placebo column.
Which is prescribed more, Restoril or Ambien?
The page shows federal survey estimates we compute from AHRQ’s Medical Expenditure Panel Survey public-use files for both temazepam and zolpidem: patients and prescriptions in the latest reliable year, and the yearly series from 2014 where AHRQ’s reliability rule allows it, with a direction stated only when the change is larger than the survey’s margin of error. Prescription volume reflects habits, prices, and marketing as much as evidence, so it is context, not a verdict.
Where these numbers come from
- Patients and prescriptions: computed by us from AHRQ's public-use Medical Expenditure Panel Survey Prescribed Medicines files, 2014 (HC-168A) to 2024 (HC-254A), with AHRQ's reliability rule (a year with fewer than 60 respondents or a relative standard error over 50% is not shown) — counts of people filling prescriptions, not outcomes. A direction is stated only when the change is larger than the survey's margin of error. Until 29 September 2026 these came from ClinCalc DrugStats, a third-party site; see the correction under each drug where a figure changed.
- Medicare/Medicaid: CMS public datasets; commercial insurance publishes no per-drug series, so it renders as an absence, never a synthesized number.
- Label facts: the drugs' current FDA labels via DailyMed — quoted in context on each drug's approval-journey page.
- FAERS: openFDA — reports, never rates; the caveat travels above every count.
- Litigation: court records and regulator documents only, on the linked record pages; settled is never adjudicated.
Explore both drugs in depth: /m/temazepam · /m/zolpidem · or the whole library →