Last reviewed 2026-05-23 · How we verify

Zolpidem IR

Astellas Pharma Inc · FDA-approved active Small molecule Under review Quality 0/100

Zolpidem IR is a Non-benzodiazepine hypnotic (Z-drug) Small molecule drug developed by Astellas Pharma Inc. It is currently FDA-approved for Insomnia (sleep-onset difficulties), Short-term treatment of insomnia in adults. Also known as: Stilnox.

Zolpidem binds to GABA-A receptors in the brain to enhance inhibitory neurotransmission and promote sleep onset.

Zolpidem IR is a small molecule that acts as a positive allosteric modulator of the GABA A receptor alpha-1/beta-1/gamma-2. It is used to treat conditions such as insomnia, insomnia disorder, chronic insomnia, and sleep initiation and maintenance disorders.

At a glance

Generic name	Zolpidem IR
Also known as	Stilnox
Sponsor	Astellas Pharma Inc
Drug class	Non-benzodiazepine hypnotic (Z-drug)
Target	GABA-A receptor (alpha-1 subunit selective)
Modality	Small molecule
Therapeutic area	Neurology / Sleep Medicine
Phase	FDA-approved

Mechanism of action

Zolpidem is a selective agonist at the alpha-1 subunit of GABA-A receptors, which are inhibitory neurotransmitter receptors in the central nervous system. By enhancing GABAergic signaling, it increases neuronal hyperpolarization and reduces excitability, leading to sedation and sleep initiation. This mechanism makes it effective for short-term treatment of insomnia, particularly for sleep-onset difficulties.

Approved indications

Insomnia (sleep-onset difficulties)
Short-term treatment of insomnia in adults

Common side effects

Dizziness
Drowsiness/somnolence
Headache
Complex sleep behaviors
Amnesia
Dependence/tolerance

Key clinical trials

A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients (PHASE4)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

Zolpidem IR CI brief — competitive landscape report
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Astellas Pharma Inc portfolio CI

Frequently asked questions about Zolpidem IR

What is Zolpidem IR?

Zolpidem IR is a Non-benzodiazepine hypnotic (Z-drug) drug developed by Astellas Pharma Inc, indicated for Insomnia (sleep-onset difficulties), Short-term treatment of insomnia in adults.

How does Zolpidem IR work?

Zolpidem binds to GABA-A receptors in the brain to enhance inhibitory neurotransmission and promote sleep onset.

What is Zolpidem IR used for?

Zolpidem IR is indicated for Insomnia (sleep-onset difficulties), Short-term treatment of insomnia in adults.

Who makes Zolpidem IR?

Zolpidem IR is developed and marketed by Astellas Pharma Inc (see full Astellas Pharma Inc pipeline at /company/astellas).

Is Zolpidem IR also known as anything else?

Zolpidem IR is also known as Stilnox.

What drug class is Zolpidem IR in?

Zolpidem IR belongs to the Non-benzodiazepine hypnotic (Z-drug) class. See all Non-benzodiazepine hypnotic (Z-drug) drugs at /class/non-benzodiazepine-hypnotic-z-drug.

What development phase is Zolpidem IR in?

Zolpidem IR is FDA-approved (marketed).

What are the side effects of Zolpidem IR?

Common side effects of Zolpidem IR include Dizziness, Drowsiness/somnolence, Headache, Complex sleep behaviors, Amnesia, Dependence/tolerance.

What does Zolpidem IR target?

Zolpidem IR targets GABA-A receptor (alpha-1 subunit selective) and is a Non-benzodiazepine hypnotic (Z-drug).

Drug class: All Non-benzodiazepine hypnotic (Z-drug) drugs
Target: All drugs targeting GABA-A receptor (alpha-1 subunit selective)
Manufacturer: Astellas Pharma Inc — full pipeline
Therapeutic area: All drugs in Neurology / Sleep Medicine
Indication: Drugs for Insomnia (sleep-onset difficulties)
Indication: Drugs for Short-term treatment of insomnia in adults
Also known as: Stilnox

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