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Zolpidem

Zolpidem is a sleep medicine (a GABA-A receptor positive modulator) used to treat insomnia, including trouble falling asleep, trouble staying asleep, and middle-of-the-night awakenings, depending on the product.

Brand names AmbienAmbien CREdluarIntermezzoZolpimist +1 more
Drug class Gamma-aminobutyric Acid-ergic Agonist
Rx Schedule CIV Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 133 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Zolpidem at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Zolpidem (Ambien) is a short-term treatment for insomnia that works on GABA-A receptors, the brain's calming system, and is one of the most prescribed sleep medicines, on the market since the early 1990s and available generically, with versions for falling asleep, staying asleep or middle-of-the-night waking. Most people tolerate it well; next-day grogginess, dizziness and headache are the usual complaints. Watch for its boxed warning about complex sleep behaviors like sleep-walking or sleep-driving, which have caused serious injuries and deaths; stop it and call your prescriber if this happens. Take it only with a full night ahead, skip alcohol, and use the lowest dose for the shortest time.

Clinical pearls

  • Take it right as you get into bed, and not with or just after a meal, since food slows it down.
  • Swallow Ambien CR whole without crushing or chewing, but let sublingual tablets dissolve under your tongue instead of swallowing them.
  • Next-morning impairment can happen even when you feel alert, so skip driving if you got less than 7 to 8 hours.
  • Sertraline and ketoconazole boost zolpidem's effect, while rifampin and St. John's wort weaken it; tell every prescriber you take it.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Zolpidem can cause complex sleep behaviors, such as sleep-walking and sleep-driving, where you do things while not fully awake and may not remember them. Some of these events have caused serious injuries, including death.

This warning appears on the extended-release tablet label. Stop the medicine right away and contact your doctor if you or someone around you notices this kind of behavior. The risk rises with higher doses and with alcohol or other sedating drugs.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Extended-release tablet, Sublingual tablet +1
Earliest FDA record1992
Companies listing it with the FDA36
FDA label last updatedAug 1, 2022
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Zolpidem, written from its FDA label.

What Zolpidem is used for

▾

Zolpidem is used to treat insomnia, and the exact use depends on the product.

  • Immediate-release tablets, including Ambien and Edluar (sublingual): short-term treatment of insomnia with trouble falling asleep.
  • Extended-release tablets, including Ambien CR: short-term treatment of insomnia with trouble falling asleep and/or staying asleep.
  • Zolpidem Tartrate Capsules: short-term treatment of transient insomnia with trouble falling asleep in adults younger than 65.
  • Zolpidem tartrate sublingual tablets (middle-of-the-night product): as-needed treatment when a middle-of-the-night awakening is followed by trouble returning to sleep. Not for use with fewer than 4 hours of bedtime left.

How Zolpidem works

▾

Zolpidem is a GABA-A receptor positive modulator. It binds to the benzodiazepine site on GABA-A receptors that contain the alpha-1 subunit. This increases how often chloride channels open, which calms nerve cell activity and helps promote sleep.

Zolpidem dosage

▾

Zolpidem is taken by mouth, or under the tongue for sublingual tablets, usually once a night. Take it right before bed when you have 7 to 8 hours left to sleep.

  • Food can slow how quickly it works.
  • Swallow extended-release tablets whole.
  • Sublingual tablets dissolve under the tongue.
  • The middle-of-the-night sublingual tablet is taken only once per night, only if 4 hours of bedtime remain.

Lowest effective dose, shortest time. Follow your prescriber and product label.

Dosing details from the FDA-approved label

From the Zolpidem prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Females (zolpidem tartrate immediate-release; capsule label)
    • Recommended starting dosage is 5 mg once nightly
    • Use another zolpidem tartrate immediate-release product for dosage initiation in females
    • Zolpidem Tartrate Capsules 7.5 mg are not used to initiate treatment in females
    • Maximum: 10 mg once nightly
    • Zolpidem clearance is lower in females; if 5 mg is not effective, may be increased to Zolpidem Tartrate Capsules 7.5 mg once nightly or 10 mg once nightly of another immediate-release product
  • Males (zolpidem tartrate immediate-release; capsule label)
    • Recommended starting dosage is either zolpidem tartrate immediate-release 5 mg, Zolpidem Tartrate Capsules 7.5 mg, or zolpidem tartrate immediate-release 10 mg, once nightly
    • Maximum: 10 mg once nightly
    • Take immediately before bedtime with at least 7 to 8 hours remaining before planned awakening; not with or immediately after a meal; swallow whole
  • Geriatric patients (capsule label)
    • Zolpidem Tartrate Capsules are not indicated
    • Avoid use
    • Use another zolpidem tartrate product
    • Recommended dosage cannot be achieved with the 7.5 mg strength
  • Mild or moderate hepatic impairment (capsule label)
    • Avoid Zolpidem Tartrate Capsules
    • Recommended dosage cannot be achieved with the 7.5 mg strength
  • Severe hepatic impairment (capsule label)
    • Avoid any zolpidem tartrate use
    • Use may contribute to encephalopathy
  • Women (sublingual tablet, middle-of-the-night awakening)
    • 1.75 mg taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep
    • Maximum: 1.75 mg
    • Take only if at least 4 hours of bedtime remain before planned waking; place under the tongue; not with or immediately after a meal
  • Men (sublingual tablet, middle-of-the-night awakening)
    • 3.5 mg taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep
    • Maximum: 3.5 mg
    • Take only if at least 4 hours of bedtime remain before planned waking; place under the tongue; not with or immediately after a meal
  • Men and women taking concomitant CNS depressants (sublingual tablet)
    • 1.75 mg
    • Dose adjustment of concomitant CNS depressants may be necessary
  • Geriatric patients over 65 years old (sublingual tablet)
    • 1.75 mg, taken only once per night if needed
    • Geriatric patients may be especially sensitive to the effects of zolpidem
  • Patients with hepatic impairment (sublingual tablet)
    • 1.75 mg, taken only once per night if needed
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ( 2.1 ) • Treatment should be as short as possible ( 2.1 ) • Recommended initial dose is a single dose of 6.25 mg for women, and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.1 ) • Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ( 2.2 ) • Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate extended-release tablets ( 2.3 ) • Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) • The effect of zolpidem tartrate extended-release tablets may be slowed if taken with or immediately after a meal ( 2.4 ) 2.1 Dosage in Adults Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS ( 5.2 )]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime. Zolpidem tartrate extended-release tablets should be taken as a single dose and should not be readministered during the same night. The recommended initial doses for women and men are different because zolpidem clearance is lower in women. Treatment with zolpidem tartrate extended-release tablet should be as short as possible. Extended treatment should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with duration of treatment [see DRUG ABUSE AND DEPENDENCE ( 9.3 )] . 2.2 Special Populations Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Zolpidem side effects

▾

The most common side effects seen in studies were:

Common side effects

  • Headache
  • Next-day sleepiness
  • Dizziness
  • Nausea
  • Anxiety
  • Tiredness
  • Memory problems
  • Hallucinations

When to get medical help

  • Get help right away if you sleep-walk, sleep-drive or do other activities while not fully awake.
  • Swelling of the tongue, throat or face, or trouble breathing, can be a severe allergic reaction (angioedema or anaphylaxis). Seek emergency care and do not take zolpidem again.
  • Call your doctor if you notice new or unusual thinking or behavior changes, such as agitation, aggressiveness, bizarre behavior or hallucinations.
  • Call your doctor if depression gets worse or you have thoughts of suicide.
  • Call your doctor if insomnia isn't better after 7 to 10 days, since another condition may be involved.
  • Seek help for extreme drowsiness, trouble breathing or inability to wake after too much zolpidem.
  • Tell your doctor about withdrawal symptoms if you stop or cut back quickly.

Zolpidem warnings and precautions

▾
  • Complex sleep behaviors: sleep-walking and sleep-driving can cause serious injury or death. Stop and call your doctor.
  • Next-day impairment: can occur even when used as directed. Avoid driving the day after use if you took too much, had under 7 to 8 hours to sleep, or used alcohol or other sedatives.
  • Allergic reactions: angioedema and anaphylaxis have occurred. Do not take again if this happens.
  • Behavior changes and depression: abnormal thinking, hallucinations, and worse depression or suicidal thinking can occur.
  • Breathing: consider the risk if you have compromised breathing.
  • Withdrawal: symptoms may occur with rapid reduction or stopping.
  • If insomnia lasts beyond 7 to 10 days, another condition may be the cause.

Zolpidem interactions

▾

Zolpidem can add to the effects of other sedating substances and be affected by some drugs.

  • Alcohol and other CNS depressants: more drowsiness and impairment.
  • Opioids: higher risk of slowed breathing.
  • Imipramine and chlorpromazine: more decreased alertness.
  • Rifampin and St. John's wort: may reduce zolpidem's effect; not recommended.
  • Ketoconazole: raises zolpidem's effect; a lower dose may be needed.
  • Sertraline: increases zolpidem levels.
  • Other sleep medicines, including other zolpidem products: not recommended at bedtime or in the middle of the night.

Interactions listed in the FDA-approved label

From the Zolpidem prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CNS depressants, including alcohol: Coadministration increases the risk of CNS depression and may increase drowsiness and psychomotor impairment, including impaired driving ability; alcohol showed an additive adverse effect on psychomotor performance. Lower doses of CNS depressants may be necessary
  • Opioids: Concomitant use may increase the risk of respiratory depression. Limit dosage and duration of concomitant use
  • Imipramine: No pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but an additive effect of decreased alertness.
  • Chlorpromazine: No pharmacokinetic interaction, but an additive effect of decreased alertness and psychomotor performance.
  • Sertraline: Concomitant administration increases exposure to zolpidem.
  • Fluoxetine: After multiple doses, an increase in zolpidem half-life (17%) was observed, with no evidence of an additive effect in psychomotor performance.
  • Haloperidol: No effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem was found; the lack of interaction after single-dose administration does not predict absence of an effect after chronic administration.
  • Rifampin (CYP3A4 inducer): Significantly reduced the exposure to and pharmacodynamic effects of zolpidem and may decrease its efficacy. Not recommended
  • St. John's wort (CYP3A4 inducer): May decrease blood levels of zolpidem. Not recommended
  • Ketoconazole (potent CYP3A4 inhibitor): Increased the exposure to and pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together
Read the label’s full interactions text

7 DRUG INTERACTIONS • CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.2 , 7.1 ) • Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) • Imipramine: Decreased alertness observed ( 7.1 ) • Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) • CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2 ) • Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 CNS-Active Drugs CNS Depressants Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 )]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 )]. Opioids The concomitant use of zolpidem tartrate extended-release tablets with opioids may increase the risk of respiratory depression. Limit dosage and duration of concomitant use of zolpidem tartrate extended-release tablets and opioids [see DOSAGE AND ADMINISTRATION ( 2.3 ), WARNINGS AND PRECAUTIONS ( 5.7 )] . Imipramine, Chlorpromazine Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [see CLINICAL PHARMACOLOGY ( 12.3 )]. Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see CLINICAL PHARMACOLOGY ( 12.3 )].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿195 supplements and herbs with documented Zolpidem interactions, ranked by severity Check Zolpidem against a supplement or herb →

Before taking Zolpidem

▾
  • Do not use if you are allergic to zolpidem.
  • Do not use extended-release tablets again if they caused complex sleep behaviors.
  • Liver disease: lower dose for mild to moderate impairment; avoid extended-release tablets in severe impairment.
  • Kidney problems: no dose adjustment was needed in the label.
  • Older adults: lower doses are used, and the risk of falls is higher.
  • Pregnancy: late-pregnancy use may cause breathing problems and sedation in newborns.
  • Breastfeeding: zolpidem passes into milk and may sedate infants.
  • Children: not recommended.

Zolpidem overdose

▾

Too much zolpidem, alone or with other sedating drugs, can cause anything from sleepiness to coma, along with heart and breathing problems, and deaths have been reported. Get emergency help or contact poison control right away. Treatment is supportive, and the sedating effect can be reduced by flumazenil in a medical setting.

What Zolpidem does in the body

▾

Zolpidem binds more strongly to GABA-A receptors with the alpha-1 subunit than to those with alpha-2 or alpha-3 subunits. It has no appreciable binding to alpha-5 receptors. This may explain the relative lack of muscle-relaxing effects in animal studies. It does not appreciably bind to dopamine, serotonin, adrenaline-type, histamine or muscarinic receptors.

How your body processes Zolpidem

▾

Extended-release tablets are absorbed in two phases: a quick start like immediate-release, then lasting levels beyond three hours. Food slows and lowers absorption, which can delay sleep onset. Zolpidem is broken down into inactive substances that leave mainly through the kidneys, and its half-life is roughly 3 hours in healthy adults. Women clear it more slowly than men, and people with liver disease clear it much more slowly.

How to store Zolpidem

▾

Store at 20ºC to 25ºC (68ºF to 77ºF) . Dispense in a tight, light-resistant, child-resistant container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

195

Supplements & herbs that interact with Zolpidem

195 supplements and herbal products have documented interactions with Zolpidem in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 147
  • Minor · 39
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major ST. JOHN'S WORT Major +187 more
Every supplement checked against Zolpidem — ranked by severity The full interaction hub: 9 major · 147 moderate · 39 minor · every one linked to its full report. Check Zolpidem against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Zolpidem: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Zolpidem — the kind of thing our pharmacy team would talk through with you at the counter.

What is zolpidem for?

▾
Zolpidem treats insomnia. Depending on the product, it helps you fall asleep, stay asleep, or get back to sleep after waking in the middle of the night. Most are meant for short-term use.

When and how should I take it?

▾
Take it right at bedtime, only when you can get a full 7 to 8 hours of sleep. Try not to take it with or right after a meal, since food can slow it down. Swallow extended-release tablets whole, and let sublingual tablets dissolve under your tongue.

Can I drink alcohol with it?

▾
No, please avoid it. Alcohol adds to drowsiness and can make your coordination and alertness worse. The same goes for other sedating medicines, so tell me everything you take.

Is it safe to drive the next day?

▾
Zolpidem can cause next-day impairment even when you feel fine. Avoid driving or anything that needs full alertness if you took more than directed, had less than a full night to sleep, or used alcohol or sedatives.

What side effects should I watch for?

▾
Headache, dizziness, nausea and next-day sleepiness are the most common. Call your doctor if you notice unusual behavior, hallucinations or worse depression. Stop and get help right away if you sleep-walk or sleep-drive, or have swelling of the face, tongue or throat.

What if my insomnia doesn't improve?

▾
If it's not better after 7 to 10 days, talk to your doctor. Another medical or mental health condition may be behind it. Don't stop suddenly without asking, since withdrawal symptoms can occur.

Is Zolpidem available over the counter?

▾
No. Zolpidem is a prescription medicine: every Zolpidem product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Zolpidem a controlled substance?

▾
Yes — Zolpidem is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Zolpidem first available?

▾
The earliest FDA record we hold for Zolpidem is from 1992: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Zolpidem was first used.

Who makes Zolpidem?

▾
36 companies currently list Zolpidem products in the FDA's NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, Proficient Rx LP. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Zolpidem on HelloPharmacist

📊Zolpidem supplement interactions195 checked — ranked by severity 🌿Drug & Supplement CheckerZolpidem vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Zolpidem NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Zolpidem Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Zolpidem forms and strengths (how it comes)

Zolpidem is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Ambien Edluar
How this form is used
What it may be used for
  • Ambien, Zolpidem and Zolpidem Tartrate tablets are for short-term treatment of insomnia with trouble falling asleep.
  • Edluar sublingual tablets are for short-term treatment of insomnia with trouble falling asleep.
Important instructions
  • Ambien and Zolpidem Tartrate tablets are taken once nightly right before bed with 7 to 8 hours left to sleep.
  • Ambien may work more slowly if taken with or right after a meal.
Available strengths 4 strengths
5 mg 6.25 mg 10 mg 12.5 mg
200 FDA-listed product records ⓘ

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Zolpidem Tartrate Extended-Release Tablets are for short-term treatment of insomnia with trouble falling asleep and/or staying asleep.
Important instructions
  • Zolpidem Tartrate Extended-Release Tablets are taken once nightly right before bed with 7 to 8 hours left to sleep.
  • Swallow Zolpidem Tartrate Extended-Release Tablets whole; do not crush, divide or chew.
  • Zolpidem Tartrate Extended-Release Tablets may work more slowly if taken with or right after a meal.
Available strengths 2 strengths
6.25 mg 12.5 mg
64 FDA-listed product records ⓘ

Sublingual tablet

Under the tongue
Brands Zolpidem tartrate sublingual
How this form is used
What it may be used for
  • Zolpidem tartrate sublingual tablets are used as needed for insomnia when a middle-of-the-night awakening is followed by trouble returning to sleep.
Important instructions
  • Place zolpidem tartrate sublingual tablets under the tongue and let them dissolve completely; do not swallow whole.
  • Take zolpidem tartrate sublingual tablets only if at least 4 hours of bedtime remain, and only once per night.
  • Zolpidem tartrate sublingual tablets may work more slowly with or right after a meal.
Available strengths 2 strengths
1.75 mg 3.5 mg
6 FDA-listed product records ⓘ

Capsule

By mouth
How this form is used
What it may be used for
  • Zolpidem Tartrate Capsules are for short-term treatment of transient insomnia with trouble falling asleep in adults younger than 65.
Important instructions
  • Zolpidem Tartrate Capsules are only available in one strength, so other zolpidem products are used for different strengths.
  • Zolpidem Tartrate Capsules should be avoided in older adults.
Available strengths 1 strength
7.5 mg
4 FDA-listed product records ⓘ

Zolpidem on the U.S. market: products, makers and brands

How Zolpidem appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

36 companies list 146 Zolpidem product records with the FDA, mostly as tablet, extended-release tablet, sublingual tablet; the earliest marketing or approval year on record is 1992. Brand names on the directory include Ambien, Ambien CR, Edluar and 3 more; the rest are generics.

4
Dose forms ⓘ
36
Labelers (makers, repackagers, distributors)
6
Brand names
146
FDA-listed product records ⓘ
1992
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack13%
Aphena Pharma Solutions - Tennessee, LLC10%
Proficient Rx LP7%
A-S Medication Solutions6%
Asclemed USA, Inc.5%
NuCare Pharmaceuticals,Inc.5%
Other makers53%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Zolpidem is used (Medicaid data)

A general measure of how commonly Zolpidem is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Zolpidem is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,428,857
Medicaid prescriptions filled (Q1–Q4 2025)
$13.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Zolpidem prescribed? Of the 1,601 medications we measure, Zolpidem ranks #132 by Medicaid prescriptions — more than 92% of them.

Where Zolpidem ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #132 of 1,601
#127 Oxcarbazepine 1,703,259 Rx #128 Tramadol 1,699,315 Rx #129 Atomoxetine 1,684,860 Rx #130 Sumatriptan 1,522,413 Rx #131 Clopidogrel 1,480,259 Rx #132 Zolpidem 1,428,857 Rx #133 Glipizide 1,400,626 Rx #134 Buprenorphine Buccal (... 1,379,027 Rx #135 Buprenorphine 1,379,027 Rx #136 Chlorhexidine 1,373,852 Rx #137 Simvastatin 1,357,663 Rx

Utilization by Zolpidem product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Zolpidem product — about 67% of these Medicaid prescriptions.

zolpidem tartrate 10 MG Oral Tablet Most dispensed

952,880 Medicaid prescriptions (Q1–Q4 2025) 67% of Zolpidem prescriptions shown $8.4M gross reimbursement (before rebates) ≈ $8.77 per prescription (gross)

Summed across the 13 of 293 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854873

zolpidem tartrate 5 MG Oral Tablet

364,389 Medicaid prescriptions (Q1–Q4 2025) 26% of Zolpidem prescriptions shown $3.1M gross reimbursement (before rebates) ≈ $8.45 per prescription (gross)

Summed across the 14 of 263 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854876

zolpidem tartrate 12.5 MG Extended Release Oral Tablet

90,758 Medicaid prescriptions (Q1–Q4 2025) 6% of Zolpidem prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 6 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854880

zolpidem tartrate 6.25 MG Extended Release Oral Tablet

20,077 Medicaid prescriptions (Q1–Q4 2025) 1% of Zolpidem prescriptions shown $277,514 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 2 of 69 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854894

zolpidem tartrate 7.5 MG Oral Capsule

518 Medicaid prescriptions (Q1–Q4 2025) <1% of Zolpidem prescriptions shown $125,030 gross reimbursement (before rebates) ≈ $241 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2637353

zolpidem tartrate 3.5 MG Sublingual Tablet

209 Medicaid prescriptions (Q1–Q4 2025) <1% of Zolpidem prescriptions shown $41,426 gross reimbursement (before rebates) ≈ $198 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1232202

zolpidem tartrate 1.75 MG Sublingual Tablet

26 Medicaid prescriptions (Q1–Q4 2025) <1% of Zolpidem prescriptions shown $5,082 gross reimbursement (before rebates) ≈ $195 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1232194

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Zolpidem, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 38 of 736 listed Zolpidem NDCs with Medicaid activity.

Compare Zolpidem products

A representative set of FDA-listed product records for Zolpidem — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 100 of 146 products — FDA National Drug Code Directory. See every product, package size and price: browse all 146 Zolpidem NDCs →

Zolpidem recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Zolpidem recall since July 2021, covering 2 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jan 18, 2024 · Completed · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
  • Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I… Lots: Lot #: DNE0893A Expires 07/31/2026 FDA record D-0272-2024 →
  • Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical… Lots: Lot #: DNE0892A Exp. 07/31/2026 FDA record D-0271-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Zolpidem RxCUI 39993 5 dose forms · 11 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 833458 In current FDA listings
    Clinical drug / strength (SCD) tartrate 10 MG RxCUI 854886 tartrate 5 MG RxCUI 854885
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 577086 In current FDA listings
    Clinical drug / strength (SCD) tartrate 12.5 MG RxCUI 854880 tartrate 6.25 MG RxCUI 854894
  3. Dose form (SCDF) Oral Capsule RxCUI 2637352 In current FDA listings
    Clinical drug / strength (SCD) tartrate 7.5 MG RxCUI 2637353
  4. Dose form (SCDF) Oral Tablet RxCUI 374364 In current FDA listings
    Clinical drug / strength (SCD) tartrate 10 MG RxCUI 854873 tartrate 5 MG RxCUI 854876

Look up RxCUI 39993 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Zolpidem costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 10 mg $12.42–$15.48 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $22.61 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $20.62 per tablet NDC details & price history
Tablet, Extended Release · Oral 12.5 mg $0.140 per tablet NDC details & price history
Tablet, Extended Release · Oral 6.25 mg $0.185 per tablet NDC details & price history
Tablet, Coated · Oral 5 mg $0.034 per tablet NDC details & price history
Tablet, Coated · Oral 10 mg $0.040 per tablet NDC details & price history
Tablet, Coated · Oral 6.25 mg $20.65 per tablet NDC details & price history
Tablet, Coated · Oral 12.5 mg $22.57 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 12.5 mg $0.109 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Zolpidem brand names

Zolpidem is sold under 6 brand names in the FDA directory — Ambien, Ambien CR, Edluar, Intermezzo and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ambien Ambien CR Edluar Intermezzo Zolpimist Zolpidem tartrate sublingual

Who makes Zolpidem: manufacturers and labelers

36 companies list Zolpidem products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 19 Aphena Pharma Solutions - Tennessee, LLC 14 Proficient Rx LP 10 A-S Medication Solutions 9 Asclemed USA, Inc. 8 NuCare Pharmaceuticals,Inc. 8 Advanced Rx of Tennessee, LLC 6 Golden State Medical Supply, Inc. 6 Preferred Pharmaceuticals Inc. 6 Advanced Rx Pharmacy of Tennessee, LLC 4 Cosette Pharmaceuticals, Inc. 4 Lupin Pharmaceuticals, Inc. 4 St. Mary's Medical Park Pharmacy 4 Sandoz Inc 4 Direct Rx 3 Remedyrepack Inc. 3 Torrent Pharmaceuticals Limited 3 ACI Healthcare USA, Inc 2 Aurobindo Pharma Limited 2 Breckenridge Pharmaceutical, Inc. 2 Chartwell RX, LLC 2 NorthStar Rx LLC 2 Northwind Health Company, LLC 2 PD-Rx Pharmaceuticals, Inc. 2

…and 12 more on the FDA NDC directory.

Zolpidem drug class (RxNorm)

Zolpidem belongs to the gamma-Aminobutyric Acid A Receptor Positive Modulator class.

Pharmacologic class gamma-Aminobutyric Acid A Receptor Positive Modulator
Drug family (ATC) Benzodiazepine related drugs
How it works GABA A Receptor Positive Modulators

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Zolpidem page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 1, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Zolpidem.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Zolpidem after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
133
Finished products in the current FDA directory
146
Companies listing them (makers, repackagers, distributors)
36
FDA labeler codes behind them ⓘ
40
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Aug 1, 2022
Composite sections available
26
Linked SPL Set ID
f76eb9d8-ca7d-4479-bd16-52a57f623b02
Linked SPL Document ID
f76eb9d8-ca7d-4479-bd16-52a57f623b02
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →