Zolpidem

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

• Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )].ICD-10: G47.00

• Zolpidem Tartrate Tablets is contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [see Warnings and Precautions ( 5.1 )] with known hypersensitivity to zolpidem.contraindicated

Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily ( 2.1 ) Treatment should be as short as possible ( 2.1 ) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Tablets ( 2.3 ) The effect of Zolpidem Tartrate 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 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 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 Tablets should not exceed 10 mg once daily immediately before bedtime. Zolpidem Tartrate 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.

CNS-Depressant Effects: Impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.7 ) Hepatic Impairment: Avoid Zolpidem Tartrate Tablets use in patients with severe hepatic impairment. ( 5.8 ) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.9 , 9.3 ) 5.1 Complex Sleep Behaviors Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of Zolpidem Tartrate Tablets. Patients can be seriously injured or injure others during complex sleep behaviors.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions ( 5.1 )] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.2 )] Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions ( 5.4 )] Abnormal thinking and behavior changes [see Warnings and Precautions ( 5.5 )] Withdrawal effects [see Warnings and Precautions ( 5.9 )] Most commonly observed adverse reactions were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1- 888-802-1213.or www.acihealthcareusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Associated with Discontinuation of Treatment Approximately 4% of 1,701 patients who received Zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received Zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction.

Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ( 8.1 ) Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after Zolpidem Tartrate Tablets administration. ( 8.2 ) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. ( 5.4 , 8.4 ) 8.1 Pregnancy Risk Summary Neonates born to mothers using Zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data]. Published data on the use of Zolpidem during pregnancy have not reported a clear association with Zolpidem and major birth defects [see Data]. Oral administration of Zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

The pharmacokinetic profile of Zolpidem Tartrate Tablets is characterized by rapid absorption from the gastrointestinal tract and a short elimination half-life (T 1/2 ) in healthy subjects. In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg Zolpidem Tartrate Tablets, the mean peak concentrations (C max ) were 59 (range: 29 to 113) and 121 (range: 58 to 272) ng/mL, respectively, occurring at a mean time (T max ) of 1.6 hours for both.

10.1 Signs and Symptoms In postmarketing experience of overdose with Zolpidem Tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported. 10.2 Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following Zolpidem overdosage, even if excitation occurs.

• Dec 16, 1992NDANDA019908Cosette
• Sep 2, 2005NDANDA021774Cosette
• Apr 23, 2007ANDAANDA077322Sandoz
• Apr 23, 2007ANDAANDA077214Acme Labs
• May 4, 2007ANDAANDA078413Aurobindo Pharma
• Aug 17, 2007ANDAANDA077903Torrent Pharms
• Mar 13, 2009NDANDA021997Viatris
• May 9, 2023NDANDA215721Almatica

1. 1Drug Ineffective8,6116.5%
2. 2Nausea8,4656.4%
3. 3Fatigue8,2246.2%
4. 4Pain6,4294.8%
5. 5Insomnia6,2914.7%
6. 6Headache6,2764.7%
7. 7Diarrhoea5,9064.4%
8. 8Fall5,5884.2%
9. 9Anxiety5,4804.1%
10. 10Dizziness5,2473.9%
11. 11Dyspnoea5,2233.9%
12. 12Vomiting4,9233.7%
13. 13Depression4,5143.4%
14. 14Asthenia4,4853.4%
15. 15Completed Suicide4,2763.2%

Recent PubMed references pinned to Zolpidem as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Effect of a Single Oral Dose of Dexamphetamine or Zolpidem on Attention and Reaction Time in Healthy Men.
  Fundamental & clinical pharmacology · 2026 · Pfoser-Poschacher V, Wolf M, Bayerle-Eder M, et al.
  PMID 42087266DOI 10.1111/fcp.70092
• Comparison of Hip Fracture Risk Between Zolpidem and Zopiclone in Older Adults.
  Human psychopharmacology · 2026 · Lai SW, Liao KF
  PMID 41913376DOI 10.1002/hup.70038
• Two Case Reports of Zolpidem Abuse and a Contemporary Review.
  Journal of psychiatric practice · 2026 · Sun R, Zhu B, Wei J, et al.
  PMID 41894193DOI 10.1097/PRA.0000000000000910
• Zolpidem restores sleep and decreases amyloid in a mouse model.
  Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026 · Yu L, Yokomizo S, Doan TH, et al.
  PMID 41810694DOI 10.1002/alz.71175
• Zolpidem use and the risk of arrhythmia: A nationwide population-based cohort study in Taiwan.
  Journal of the Chinese Medical Association : JCMA · 2026 · Chen HJ, Ou H, Shen JY, et al.
  PMID 41772758DOI 10.1097/JCMA.0000000000001360
• Population Pharmacokinetic-Pharmacodynamic Analysis of Zolpidem in Healthy Volunteers: Covariate Contributions to Variability in CNS Responses.
  CPT: pharmacometrics & systems pharmacology · 2026 · Kim HC, Sunwoo J, Yoon S, et al.
  PMID 41749515DOI 10.1002/psp4.70208
• Zolpidem Withdrawal Delirium Developed as Severe Psychiatric and Physical Symptoms in a Patient With a History of Ovarian Cancer: A Case Report and Literature Review.
  Neuropsychopharmacology reports · 2026 · Yamaguchi J, Sadahiro R, Wada S, et al.
  PMID 41587361DOI 10.1002/npr2.70090
• Hypnotic doses of fazamorexant induced less impairment on balance and cognition than zolpidem in healthy younger and elderly individuals.
  British journal of clinical pharmacology · 2026 · Xia C, Xingxing H, Lu J, et al.
  PMID 41554554DOI 10.1002/bcp.70414

The 10 most recently updated of 150 ClinicalTrials.gov registrations naming Zolpidem as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Sleep, Light, Circadian, Central Oxidative Stress
  Not yet recruiting · Interventional · 40 enrolled · Beth Israel Deaconess Medical Center
  NCT07471126updated 2026-06-11
• A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
  Recruiting · Phase 4 · Interventional · 1,200 enrolled · University of Pennsylvania
  NCT07542756updated 2026-06-05
• Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
  Not yet recruiting · Phase 3 · Interventional · 30 enrolled · Emory University
  NCT07336277updated 2026-05-08
• The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
  Recruiting · Phase 4 · Interventional · 140 enrolled · University of Southern California
  NCT05746143updated 2026-05-01
• Psilocybin Therapy for Chronic Low Back Pain
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · Joshua Woolley, MD, PhD
  NCT05351541updated 2026-04-29
• The Study in Outpatient Medicine Using Nudges to Improve Sleep
  Enrolling by invitation · Interventional · 444 enrolled · University of Southern California
  NCT06640023updated 2026-04-27
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Observational · 5,000 enrolled · Duke University
  NCT04278404updated 2026-04-06
• Trial of Zolpidem for Sleep in Children With Autism
  Recruiting · Phase 2 · Interventional · 26 enrolled · Stanford University
  NCT05540574updated 2026-03-27
• Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment
  Recruiting · Phase 4 · Interventional · 200 enrolled · VA Office of Research and Development
  NCT04118387updated 2026-03-13
• Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
  Not yet recruiting · Phase 2 · Interventional · 222 enrolled · Apsen Farmaceutica S.A.
  NCT07420816updated 2026-02-19

Frequently asked questions

How does Zolpidem work?

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

What is Zolpidem used for?

According to FDA labeling, Zolpidem carries indications including: Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Zolpidem?

Zolpidem is classified as Benzodiazepine related drugs, gamma-Aminobutyric Acid A Receptor Positive Modulator, GABA A Agonists, GABA A Modulators, GABA A Receptor Positive Modulators, Central Nervous System Depression, Decreased Central Nervous System Organized Electrical Activity.

What are the brand names for Zolpidem?

Zolpidem is marketed under brand names including Ambien, Edluar, Zolpimist.

What are the contraindications for Zolpidem?

Zolpidem labeling lists contraindications including: Zolpidem Tartrate Tablets is contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [see Warnings and Precautions ( 5.1 )] with known hypersensitivity to zolpidem.. Always consult the full prescribing information and a clinician.