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Zolpidem

Generic Name
Zolpidem
Brand Names
Ambien, Edluar, Intermezzo, Tovalt
Drug Type
Small Molecule
Chemical Formula
C19H21N3O
CAS Number
82626-48-0
Unique Ingredient Identifier
7K383OQI23

Overview

Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 . Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms , . Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance . In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties . Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury , .

Background

Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 . Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms , . Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance . In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties . Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury , .

Indication

This drug is indicated for the short-term treatment of insomnia in adults characterized by difficulties with sleep initiation .

Associated Conditions

  • Insomnia

Clinical Trials

FDA Approved Products

Zolpidem Tartrate
Manufacturer:Quality Care Products, LLC
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/08/02
NDC:83008-014
ZOLPIDEM TARTRATE
Manufacturer:DirectRX
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/01/12
NDC:61919-663
Zolpidem Tartrate
Manufacturer:Quality Care Products, LLC
Route:ORAL
Strength:6.25 mg in 1 1
Approved: 2023/08/16
NDC:55700-971
ZOLPIDEM TARTRATE
Manufacturer:PD-Rx Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/04/03
NDC:43063-639
ZOLPIDEM TARTRATE
Manufacturer:Proficient Rx LP
Route:ORAL
Strength:12.5 mg in 1 1
Approved: 2022/11/01
NDC:71205-286

Singapore Approved Products

STILNOX CR 12.5mg Modified Release Tablet
Manufacturer:SANOFI WINTHROP INDUSTRIE
Form:TABLET, MULTILAYER, EXTENDED RELEASE
Strength:6.0mg & 6.5mg
Online:Yes
Approved: 2008/01/28
Approval:SIN13403P
STILNOX CR 6.25mg Modified Release Tablet
Manufacturer:SANOFI WINTHROP INDUSTRIE
Form:TABLET, MULTILAYER, EXTENDED RELEASE
Strength:3.000mg & 3.250mg
Online:Yes
Approved: 2008/01/28
Approval:SIN13402P

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