Last reviewed 2026-05-22 · How we verify

Ambien (zolpidem)

Ambien (generic name: zolpidem) is a drug developed by Sanofi. It is currently FDA-approved for Initial insomnia, Insomnia.

Zolpidem binds to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing chloride channel opening and inhibiting neuronal excitation.

Ambien, also known as zolpidem, is a medication primarily used for the short-term treatment of sleeping problems, specifically insomnia. It works by acting as a positive allosteric modulator of the GABA A receptor alpha-1/beta-1/gamma-2, helping to decrease the time to sleep onset and improve sleep duration.

At a glance

Mechanism of action

Zolpidem works by binding to specific sites on GABA A receptors that contain the α1 subunit. This binding increases the frequency at which chloride channels open, leading to a reduction in neuronal activity and promoting sleep.

Approved indications

• Initial insomnia
• Insomnia

Boxed warnings

• WARNING: COMPLEX SLEEP BEHAVIOUR Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Tablets. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Tablets . Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )

Common side effects

• Headache
• Dizziness
• Drowsiness
• Drugged feelings
• Daytime drowsiness
• Diarrhea
• Dizziness/vertigo
• Nausea
• Vomiting
• Amnesia
• Falls
• Impaired concentration

Serious adverse events

• Attempted suicide

Key clinical trials

• Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep (NA)
• A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Te (Phase 2)
• Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatmen (Phase 2)
• A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of 10 Days of Repeat Dosing of GSK1521498 in Overweight or Ob (Phase 1)
• A Relative BioAvailability Study of Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions (Phase 1)
• Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment (Phase 4)
• A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Cent (Phase 1)
• A Single-Dose, Double-Blind, Placebo-Controlled, Randomized, Crossover Study to Determine the Abuse Potential of Single Oral Dose of Seltorexant Compared To Suvorexant and Zolpidem (Phase 1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ambien CI brief — competitive landscape report
• Ambien updates RSS · CI watch RSS
• Sanofi portfolio CI

Frequently asked questions about Ambien

Related

• Target: All drugs targeting α1 subunit containing GABA A receptors
• Manufacturer: Sanofi — full pipeline
• Therapeutic area: All drugs in Neuroscience
• Indication: Drugs for Initial insomnia
• Indication: Drugs for Insomnia

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing