SOMNOTE SUMMARY
Each capsule for oral administration contains
Chloral Hydrate, USP 500 mg.
Warning: May be habit forming
Chloral Hydrate acts as a sedative and hypnotic.
Somnote (Chloral) is indicated for the following:
Chloral Hydrate is used primarily as a hypnotic in the management of simple insomnia. It is effective as a hypnotic only for short term use. Chloral Hydrate has been found to lose much of its effectiveness for both inducing and maintaining sleep by the end of a 2 week period of administration. Chloral Hydrate may also be used as a routine sedative. It has been used preoperatively or prior to electroencephalographic evaluation to allay anxiety and produce sedation and/or sleep. Chloral Hydrate, alone or in conjunction with Paraldehyde, may be effective in suppressing and/or reducing alcohol withdrawal symptoms. It may also be effective in reducing anxiety associated with withdrawal of other drugs such as narcotics or barbiturates.
|
NEWS HIGHLIGHTS
Published Studies Related to Somnote (Chloral)
A comparison of oral chloral hydrate and sublingual midazolam sedation for echocardiogram in children. [2008.10]
CONCLUSION: Sublingual midazolam at the dose of 0.3 mg/kg can be used to sedate the children at age group between 6 months to 5 years who undergoing echocardiogram with comparable rate of success and safety as 50 mg/kg of chloral hydrate orally. The less depth in the level of consciousness after sedation with midazolam compare to chloral hydrate may be advantage in a high risk patient to avoid deep sedation but may be disadvantage in case who need more comprehensive echocardiographic evaluation.
Sedative effect of oral diazepam and chloral hydrate in the dental treatment of children. [2007.04]
PURPOSE: The purpose was to evaluate two sedation protocols during dental sessions in anxious children. MATERIALS AND METHODS: It was a randomized and double-blind study, with each individual being his/her own control within each protocol... It was concluded that oral diazepam and chloral hydrate had no influence on the behavior management for dental treatment with the studied sample.
A randomized double-blinded trial of chloral hydrate with or without hydroxyzine versus placebo for pediatric dental sedation. [2007]
Chloral hydrate and hydroxyzine are a drug combination frequently used by practitioners to sedate pediatric dental patients, but their effectiveness has not been compared to a negative control group in humans. The aim of this crossover, double-blinded study was to evaluate the effect of these drugs compared to a placebo, administered to young children for dental treatment...
Psychological and behavioral effects of chloral hydrate in day-case pediatric
surgery: a randomized, observer-blinded study. [2012]
psychological and behavioral phenomena in children... CONCLUSION: Decreasing preoperative anxiety with oral chloral hydrate improves
Use of chloral hydrate as a sedative for auditory brainstem response testing in a pediatric population. [2011.06]
OBJECTIVE: Chloral hydrate (CH) is an oral sedative widely used to sedate infants and young children during auditory brainstem response (ABR) testing. The aim of this study was to record effectiveness, complications and safety of CH as a sedative for ABR... CONCLUSIONS: The use of CH at a dose of 40 mg/kg up to 80 mg/kg is safe and effective when administered in a setting with adequate equipment and the presence of well trained personnel. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
Clinical Trials Related to Somnote (Chloral)
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam [Not yet recruiting]
Thousands of children receive sedation for diagnostic and therapeutic interventions
annually, and this number is expected to increase. Children are at higher risk for
sedation-related complications than adults. In different scenarios, multiple drugs are used
to achieve sedation, each one with particular adverse events that must be monitored and
reported.
Children that need CT scans for traumatic brain injuries often need sedation, without
needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low
incidence of adverse events; however, despite its worldwide use, it's being abandoned due to
bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam,
on the other hand, produces high and fast concentrations on CSF with greater rates of
success but probably with higher adverse events. There are no prospective studies with large
series of patients using intranasal midazolam.
The aim of this study is to determine if nasal midazolam is a safer approach and more
effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT
scans.
Pharmacotoxicology of Trichloroethylene Metabolites [Recruiting]
This is a research study to look at how Dichloroacetate (DCA), and investigational drug and
chloral hydrate are broken down in the body. The purpose of the study is to better
understand how humans metabolize these two common chemicals that are widely present in the
environment. The study focuses on how the drug chloral hydrate is broken down and how it
effects DCA
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams [Not yet recruiting]
Pharmacotoxicology of Trichloroethylene Metabolites: In Vivo Kinetics and Biotransformation of Chloral Hydrate [Not yet recruiting]
Specific Aim 3: Determine the in vivo kinetics and biotransformation of CH in healthy adults
and the influence of CH and DCA on each other's metabolism. This specific aim will examine
three postulates: 1) CH is metabolized in adults to DCA, 2) CH, via DCA formation, inhibits
its own metabolism and that of tyrosine and 3) these effects are dependent upon exposure
level but not upon gender. Both 13C and 12C CH and 13C DCA will be administered by mouth at
environmentally relevant (μg/kg) and clinically relevant (mg/kg) doses to adult men and
women and the kinetics and metabolism of these chemicals will be identified and quantitated
using GC-MS and LC-MS.
Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery [Not yet recruiting]
|
