Chloral hydrate

Overview

A hypnotic and sedative used in the treatment of insomnia. The safety margin is too narrow for chloral hydrate to be used as a general anesthetic in humans, but it is commonly used for that purpose in animal experiments. It is no longer considered useful as an anti-anxiety medication.

Indication

Mainly used as a hypnotic in the treatment of insomnia; however, it is only effective as a hypnotic for short-term use. May be used as a routine sedative preoperatively to decrease anxiety and cause sedation and/or sleep with respiration depression or cough reflex.

Associated Conditions

Alcohol Withdrawal Syndrome
Opioid Withdrawal (Disorder)
Postoperative pain
Barbiturate withdrawal

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Comparison Between Oral Melatonin With Nasal Sevoflurane Versus Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Children Undergoing Brain MRI	2024/09/23	NCT06606899	Phase 4	Completed	Ain Shams University
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia	2023/09/26	NCT06053840	Phase 4	Completed	Pharmanovia
Sedation and Nursing Management in EEG Recording in Children	2022/08/09	NCT05492812	Not Applicable	Completed	Suleyman Demirel University
Dexmedetomidine in Children Having Transthoracic Echocardiography	2015/08/14	NCT02523144	Phase 4	Completed	Children's Hospital Medical Center, Cincinnati
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children	2014/07/21	NCT02195661	Phase 3	Completed	University of Cape Town
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam	2011/07/26	NCT01402596	Phase 2	Withdrawn	University of Sao Paulo
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams	2010/12/08	NCT01255904	Phase 4	Completed	Baylor College of Medicine
Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery	2010/06/28	NCT01149226	Not Applicable	Completed	Yonsei University
Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate	2010/03/10	NCT01083797	Phase 3	Completed	Federal University of Minas Gerais

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SYRUP OF CHLORAL, 1G/5ML	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	3/31/1984

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ORION CHLORAL HYDRATE MIXTURE 500mg/10mL bottle	42849	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	11/26/1992
ORION CHLORAL HYDRATE MIXTURE 1g/10mL bottle	42850	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	11/26/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NOVO-CHLORHYDRATE CAP 500MG	novopharm limited	00020893	Capsule - Oral	500 MG / CAP	12/31/1967
CHLORAL HYDRATE SYRUP ODAN	odan laboratories ltd	02247621	Syrup - Oral	500 MG / 5 ML	8/6/2003
CORT SYM	terra botanica products ltd.	02233310	Gel - Topical	12 X	1/8/1998
CALMITOL ITCHING RELIEF ONT	pfizer canada inc., consumer healthcare division	01942565	Ointment - Topical	.496 %	12/31/1964
ANALGESIC BALM	d.c. labs limited	00270865	Ointment - Topical	1 G / 100 G	12/31/1966
CHLORUM	seroyal international inc.	02233747	Globules , Pellet , Drops , Liquid , Granules , Tablet - Oral	6 X	4/6/1998
PMS-CHLORAL HYDRATE SYRUP 100MG/ML	Pharmascience Inc	00792659	Syrup - Oral	500 MG / 5 ML	12/31/1990
CHLORAL HYDRATE CAPSULES 500MG	d.c. labs limited	00092886	Capsule - Oral	500 MG / CAP	12/31/1968
APO-CHLORAL HYDRATE SYRUP	Apotex Inc	02250195	Syrup - Oral	100 MG / ML	N/A
PMS-CHLORAL HYDRATE CAPSULES 500MG	Pharmascience Inc	00811882	Capsule - Oral	500 MG	10/10/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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