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Somnote (Chloral Hydrate) - Summary

 
 



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.


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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...

Oral chloral hydrate vs. intranasal midazolam for sedation during computerized tomography. [2013]
We conducted this single blind randomized clinical trial to compare the efficacy and safety of oral chloral hydrate and intranasal midazolam for induction of sedation for computerized tomography scan of brain in children. Participants aged 1-10 years (n=60) were randomized to receive 100 mg/kg chloral hydrate orally with intra nasal normal saline OR intranasal midazolam 0.2 mg/kg with oral normal saline...

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

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Clinical Trials Related to Somnote (Chloral)

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate [Completed]
This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. The hypothesis is that this drugs provides similar changes in EEG pattern.

Chloral Hydrate to Perform Auditory Brainstem Response (ABR) [Completed]
Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in pediatric and dental procedures owing to the low depressive effect it has over respiratory and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and sudden death in children, especially when using high doses, probably due to accumulation of serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the drug. A possible carcinogenic action observed in guinea pigs has also been reported, even though it has not been confirmed in human beings. Among the least severe complications there are paradoxical agitation, nausea, vomiting and excessive sleepiness. CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test (ABR), in which any movement or muscle contraction may generate artifacts that interfere in the analysis. Profound sleep that lasts on average one hour is rapidly induced depending on the used dose, causing no residual sleepiness after this period; however, there is consensus in the literature about the best dose, which may range from 40 to 100 mg/kg. Objective: To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.

Pharmacotoxicology of Trichloroethylene Metabolites [Completed]
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

Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam [Withdrawn]
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.

Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging [Completed]
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.

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Page last updated: 2014-12-01

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