PEDEvidence

Zolpidem (Ambien / Ambien CR)

What it is & what research shows

Study example available

Zolpidem is a sleep medicine available in immediate-release and extended-release forms. This study concerns the extended-release formulation used for sleep onset and maintenance. 1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial. [1.1]

Selected human research: 1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial. At week 12, the primary patient-rated sleep-help outcome was favorable in 89.8% versus 51.4%. Sleep onset and maintenance reports also improved. Common adverse events included headache, anxiety and sleepiness. Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors. This is a selected trial summary, not a full literature review or formal quality appraisal. [2.1]

Studied methods, not dosing advice. Selected evidence, not a complete literature review or formal quality appraisal.
Sources & reading scope

Study-summary coverage

No completed study summaries are linked to this compound page yet. This is a coverage gap on PED Evidence, not evidence that human studies or other research do not exist.

Filter, save and compare Zolpidem studies →

Selected study reading notes

Source-linked summaries with studied methods. These are separate from the automated summary counts above and are not formal quality appraisals.

Human

Zolpidem: what did the insomnia trial show?

1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial.

Demonstrated findings

At week 12, the primary patient-rated sleep-help outcome was favorable in 89.8% versus 51.4%. Sleep onset and maintenance reports also improved. Common adverse events included headache, anxiety and sleepiness.

Limitations & adverse findings

Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

More about Zolpidem: identity, safety & reference details
Small moleculeSleep & insomnia
Primary research area
Sleep · insomnia
Regulatory status
See formulation-specific sources
Evidence level
Human randomized trials
Primary mechanism
Z-drug hypnotic
Reference profile available · Coverage varies by section

Also known as Ambien · Ambien CR

What has been observed?

Selected source-linked reading notes, not the complete literature or a pooled conclusion.

Human · Abstract reviewed

Zolpidem: what did the insomnia trial show?

1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial.

At week 12, the primary patient-rated sleep-help outcome was favorable in 89.8% versus 51.4%. Sleep onset and maintenance reports also improved. Common adverse events included headache, anxiety and sleepiness.

Limits & adverse findings: This is a selected trial summary, not a full literature review or formal quality appraisal. Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors.

Open primary source · Read interpretation separately
Explore outcomes for this compound
Uses & research

1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial. [1]

Known half-life

No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.

Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.
Evidence & important limits

Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors. [1][2]

Safety & evidence boundaries

Source-specific information, not a personal safety clearance or monitoring plan.

Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors.

Human study: Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors. Source

Explore safety questions by system

These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.

Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.

Identity, names & formulations

Canonical compound: Zolpidem · zolpidem

Searchable names: Ambien, Ambien CR

Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.

Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.

Understand the evidence types

Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.

Randomized human trials
Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
Controlled human studies
Use a comparison group; allocation and confounding still matter.
Prospective human research
Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
Observational human research
Describes associations. Confounding can explain differences.
Case reports and series
Useful for unusual events and safety signals, not reliable rates or effect sizes.
Animal research
Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
Cell and tissue research
Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
Mechanistic and computational evidence
Helps explain or predict a pathway; predictions need experimental and clinical testing.
Anecdotal reports
Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.

Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.

Sources for this profile

  1. 1. Zolpidem extended-release: 24-week placebo-controlled trial Human randomized trial · abstract
  2. 2. FDA: Z-drug boxed warnings Regulator safety information

Reference facts checked 2026-09-23. Source scope is listed above; this is not a formal quality appraisal. See each label for full prescribing information.

Browse all studies

Study model describes the source. Confidence depends on methods, replication, population and outcome.

Loading compound research…