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Zolpidem

Generic Name: Zolpidem

Brand Names: Ambien

Zolpidem is a sedative-hypnotic used for short-term treatment of insomnia.

Mental HealthSleep Aids

Drug Class

Non-Benzodiazepine Hypnotic (Imidazopyridine — GABA-A receptor agonist)

DEA Schedule

Schedule Schedule IV

Pregnancy

Category C — Animal studies have shown adverse fetal effects. No adequate human studies. Use in pregnancy only if the potential benefit justifies the potential risk. Neonatal sedation and respiratory depression have been reported with use near delivery.

Available Forms

Tablet (immediate-release): 5 mg, 10 mg, Tablet (extended-release, Ambien CR): 6.25 mg, 12.5 mg, Sublingual tablet (Edluar): 5 mg, 10 mg, Sublingual tablet (Intermezzo — middle-of-night): 1.75 mg, 3.5 mg, Oral spray (Zolpimist): 5 mg/spray

What It's Used For

Dosage Quick Reference

These are general dosage guidelines. Your doctor will determine the appropriate dose for your specific situation.

FormulationWomen — Starting DoseMen — Starting DoseMaximum Dose
Immediate-release5 mg at bedtime5 mg at bedtime10 mg at bedtime
Extended-release (Ambien CR)6.25 mg at bedtime6.25 mg at bedtime12.5 mg at bedtime
Sublingual (Intermezzo, middle-of-night)1.75 mg3.5 mg3.5 mg

Side Effects

Common Side Effects:

  • Drowsiness (including next-day)
  • Dizziness
  • Diarrhea
  • Drugged feeling
  • Headache

Serious Side Effects:

  • Complex sleep behaviors (sleepwalking, sleep-driving, sleep-eating)
  • Amnesia
  • Anaphylaxis/angioedema
  • Abnormal thinking/behavioral changes
  • Depression worsening
  • Respiratory depression

Drug Interactions

  • CNS depressants (benzodiazepines, opioids, alcohol) — Combined use causes additive CNS depression, respiratory depression, and increased sedation. Avoid concomitant use, especially with opioids.
  • CYP3A4 inhibitors (ketoconazole, itraconazole) — Increase zolpidem plasma levels, enhancing sedative effects. Consider dose reduction.
  • CYP3A4 inducers (rifampin, St. John's wort) — Decrease zolpidem concentrations and may reduce efficacy.
  • SSRIs (sertraline, fluoxetine) — Co-administration with sertraline increased zolpidem exposure. Monitor for excessive sedation.
  • Chlorpromazine — Additive CNS depression and reduced alertness. Avoid combination.

Additional Information

Zolpidem is a non-benzodiazepine sedative-hypnotic (imidazopyridine class) widely used to treat insomnia. It is one of the most commonly prescribed sleep medications and is available in multiple formulations for different sleep problems.

Mechanism of Action

Zolpidem works through GABAergic modulation:

  • GABA-A receptor positive modulation: Binds to benzodiazepine binding site on GABA-A receptors
  • Selective for alpha-1 subunit: Preferentially affects sedative/hypnotic function over anxiolytic/muscle relaxant
  • Enhances inhibitory neurotransmission: Increases chloride conductance
  • Rapid onset: Quickly induces sleep
  • Various durations: Different formulations provide different duration of action

Available Formulations

  • Immediate-release tablets: 5 mg, 10 mg (Ambien)
  • Extended-release tablets: 6.25 mg, 12.5 mg (Ambien CR)
  • Sublingual tablets (low dose): 1.75 mg, 3.5 mg (Intermezzo - for middle-of-night awakening)
  • Sublingual tablets: 5 mg, 10 mg (Edluar)
  • Oral spray: 5 mg/actuation, 10 mg/actuation (Zolpimist)

Medical Uses

FDA-Approved Indication:

  • Short-term treatment of insomnia characterized by difficulty with sleep initiation (IR, sublingual, spray)
  • Insomnia with difficulty falling asleep and/or staying asleep (ER)
  • Middle-of-night awakening with difficulty returning to sleep (Intermezzo)

Dosing Guidelines

Immediate-Release:

  • Women: 5 mg immediately before bedtime
  • Men: 5-10 mg immediately before bedtime
  • Maximum: 10 mg/night

Extended-Release:

  • Women: 6.25 mg immediately before bedtime
  • Men: 6.25-12.5 mg immediately before bedtime
  • Maximum: 12.5 mg/night

Sublingual (Middle-of-Night - Intermezzo):

  • Women: 1.75 mg
  • Men: 3.5 mg
  • Take only if 4+ hours remain before planned awakening

Important Safety Information

Controlled Substance:

  • Schedule IV

Boxed Warning (2019):

  • Complex sleep behaviors including sleep-walking, sleep-driving, and other activities while not fully awake that may result in serious injury or death

Contraindications:

  • Known hypersensitivity to zolpidem
  • History of complex sleep behaviors with zolpidem

Warnings and Precautions:

  • Complex sleep behaviors: Discontinue immediately if occurs
  • CNS depression: Additive with other CNS depressants
  • Next-day impairment: Especially with higher doses, ER formulation, and in women
  • Depression: May worsen; suicidal ideation reported
  • Respiratory depression: Use caution in compromised respiratory function
  • Dependence: Physical and psychological dependence possible

Drug Interactions

  • CNS depressants (alcohol, opioids, benzodiazepines): Additive CNS depression; avoid alcohol
  • CYP3A4 inhibitors (ketoconazole): May increase zolpidem levels
  • CYP3A4 inducers (rifampin): May decrease zolpidem effectiveness
  • Chlorpromazine: Decreased alertness and psychomotor performance
  • Sertraline: May increase zolpidem exposure

Special Populations

  • Hepatic Impairment: 5 mg IR or 6.25 mg ER; avoid in severe impairment
  • Renal Impairment: No adjustment for mild to moderate
  • Elderly: Start with lowest dose; increased sensitivity
  • Women: Lower doses recommended (slower metabolism)
  • Pregnancy: May cause respiratory depression and sedation in neonates
  • Lactation: Present in milk; consider timing and infant monitoring
  • Pediatric: Not approved for children

Frequently Asked Questions

The FDA lowered the recommended starting dose for women because studies showed that women eliminate zolpidem more slowly than men, resulting in higher morning blood levels. This increases the risk of next-morning impairment, including impaired driving. Women should start at 5 mg (immediate-release) or 6.25 mg (extended-release).
Yes. Zolpidem carries a boxed warning for complex sleep behaviors including sleepwalking, sleep-driving, and engaging in activities while not fully awake (cooking, making phone calls). If you experience any of these behaviors, discontinue the medication and contact your doctor immediately.
Zolpidem is a DEA Schedule IV controlled substance, indicating some potential for dependence and abuse. Physical dependence can develop with prolonged use, and withdrawal symptoms (insomnia, anxiety, tremors) may occur if stopped abruptly. It is generally recommended for short-term use (2–4 weeks).
Zolpidem is typically intended for short-term use, generally 2–4 weeks. If insomnia persists beyond this period, your doctor should re-evaluate the underlying cause. Long-term use increases the risk of dependence and tolerance.
A specific low-dose sublingual formulation (Intermezzo) is designed for middle-of-the-night awakenings. However, you should only take it if you have at least 4 hours of bedtime remaining. Standard zolpidem formulations should not be taken in the middle of the night.

Related Health Conditions

This medication is commonly used to treat or manage the following conditions:

Lupus Anticoagulant

Lupus anticoagulant is an antibody causing paradoxical prolonged clotting tests yet increasing thrombosis risk, linked to antiphospholipid syndrome and autoimmune diseases, despite not always requiring lupus diagnosis.

Learn More

Medical Disclaimer: This information is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication. Your doctor can provide personalized recommendations based on your specific health condition and medical history.

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Questions About This Medication?

Talk to your doctor or pharmacist about whether Zolpidem is right for you.

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