Wednesday, July 8, 2026

Drug profile · INN

zaleplon

zaleplon (SONATA) is a gaba a receptor alpha-1/beta-1/gamma-2 positive allosteric modulator. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Nervous system (N05) N05CF03
US status approved
Patents linked 2
Pipeline programs 1
News articles 0
Drug details — zaleplon
US status
approved
Class
Nervous system (N05)
Route
ORAL
Patents
2
Programs
1
Data quality
0.89

Quick answer

zaleplon (SONATA) is a gaba a receptor alpha-1/beta-1/gamma-2 positive allosteric modulator. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN zaleplon
Brand SONATA
Mechanism GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator
Target GABA A receptor alpha-1/beta-1/gamma-2
Therapeutic class Nervous system (N05)
Route ORAL
Formulation CAPSULE
ATC code N05CF03

Mechanism of action

GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator

Primary target: GABA A receptor alpha-1/beta-1/gamma-2

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. Zaleplon 10 mg Capsules Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 7348429

    Process for purifying N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide(zaleplon) and crystalline forms of zaleplon accessible with the process

    Expires Mon Mar 20 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 6884888

    Process for the production of N-[3-(3-cyanopyrazolo[1,5-a] pyrimidin-7-yl) phenyl]-N-ethylacetamide (zaleplon)

    Expires Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is zaleplon?

zaleplon (SONATA) is a gaba a receptor alpha-1/beta-1/gamma-2 positive allosteric modulator. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for zaleplon?

SONATA is a marketed brand name for zaleplon. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of zaleplon?

zaleplon has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.