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Chloral hydrate (United States: Not available): Drug information

Chloral hydrate (United States: Not available): Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Chloral hydrate (United States: Not available): Patient drug information" and "Chloral hydrate (United States: Not available): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • Chloral Hydrate Odan;
  • PMS-Chloral Hydrate [DSC]
Pharmacologic Category
  • Hypnotic, Miscellaneous
Dosing: Adult
Procedural sedation

Procedural sedation: Note: Not routinely used in adults; other agents are preferred for procedural sedation (Ref).

Oral: 500 mg to 1 g once; administer 30 minutes prior to surgery/procedure.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Use is contraindicated.

Dosing: Liver Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Severe impairment: Use is contraindicated.

Dosing: Pediatric

(For additional information see "Chloral hydrate (United States: Not available): Pediatric drug information")

Note: Commercially available product no longer available in the United States.

Sedation, mechanically ventilated patient

Sedation, mechanically ventilated patient: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 8 to 25 mg/kg/dose every 6 to 8 hours; titrate to effect based on patient response up to 50 mg/kg/dose every 6 hours; maximum dose: 1,000 mg/dose (Ref). Dosing based on randomized controlled trial of 44 patients (age range: 1 day to 15 years) that compared continuous infusion midazolam (n=20) to promethazine plus chloral hydrate (n=23) at a dose of 25 mg/kg/dose every 6 hours for sedation in ventilated patients. If sedation unsatisfactory, doses could be increased up to 50 mg/kg/dose every 6 hours. The total number of satisfactory sedation assessments was significantly higher in the chloral hydrate/promethazine group (61%) compared to the midazolam group (48%) (Ref).

Sedation, procedural

Sedation, procedural (eg, echocardiogram or EEG): Limited data available: Infants and Children (best results in children <3 years of age): Oral: 25 to 100 mg/kg/dose 10 to 30 minutes prior to procedure; maximum dose: 1,000 mg/dose; may repeat after 30 minutes with 25 to 50 mg/kg/dose if necessary. Maximum total dose: 100 mg/kg/procedure or 2,000 mg/procedure (Ref). Note: Although dosing may be used in adolescent patients, use in these patients is not common; older children and adolescent patients may not require sedation for echocardiogram and other agents should be used for EEG.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use is contraindicated in patients with marked renal impairment.

Dialysis: Dialyzable.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use is contraindicated in patients with marked hepatic impairment.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Atrial arrhythmia, depression of myocardial contractility, hypotension, shortening of refractory periods, supraventricular tachycardia (infants and children) (Hirsch 1986), torsades de pointes, ventricular arrhythmia

Dermatologic: Allergic skin rash (including bullous dermatitis, eczema, erythema multiforme, erythema of skin, scarlatiniform rash, urticaria)

Endocrine & metabolic: Acute intermittent porphyria, ketonuria

Gastrointestinal: Diarrhea, flatulence, gastric irritation, intestinal obstruction (infants), nausea, unpleasant taste, vomiting

Hematologic & oncologic: Eosinophilia, leukopenia, nonthrombocytopenic purpura

Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms (Yoo 2014)

Nervous system: Abnormal gait (staggering), ataxia, confusion, delirium, dizziness, drowsiness, drug dependence, excitement, hallucinations, hangover effect, malaise, nightmares, seizure (Muñoz 1997), somnambulism, vertigo

Ophthalmic: Allergic conjunctivitis, blepharoptosis, keratoconjunctivitis

Otic: Increased middle ear pressure (infants and children)

Respiratory: Airway obstruction (young children), laryngeal edema (children)

Miscellaneous: Drug tolerance, paradoxical reaction (Slatt 2009)

Contraindications

Hypersensitivity to chloral hydrate or any component of the formulation; marked hepatic or renal impairment

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Cardiac disease: Avoid use in patients with severe cardiac disease; larger doses may precipitate arrhythmias and hypotension (Fazio 2013).

• Gastrointestinal disorders: Because of irritant properties, avoid use in patients with gastritis, esophagitis, or gastric/duodenal ulcer (Joffe 2017).

• Porphyria: Although manufacturer labeling suggests choral hydrate may precipitate attacks of acute intermittent porphyria and to use with caution, chloral hydrate is considered to be safe based on evidence and expert consensus (Porphyria Foundation) (Crimlisk 1997; Gorchein 1997; Jensen 1995; Porphyria Foundation 2023).

• Respiratory disease: Closely monitor patients with respiratory insufficiency.

Special populations:

• Children: Life-threatening respiratory obstruction and deaths have been reported with use in children; use with extreme caution.

• Older adult: Excessive sedation or other adverse effects may be more likely to occur in elderly patients; avoid use in older adults.

• Neonates: Prolonged use in neonates is associated with direct hyperbilirubinemia (active metabolite [TCE] competes with bilirubin for glucuronide conjugation in the liver).

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Abuse/misuse/diversion: May be habit forming; long-term use or larger than therapeutic doses may result in tolerance and in physical and/or psychological dependance. Use with caution in patients with a history of substance abuse disorder, mentally depressed, or suicidal. Sudden withdrawal may result in hallucinations and symptoms similar to delirium tremens (sometimes fatal); taper chloral hydrate gradually.

Warnings: Additional Pediatric Considerations

Deaths and permanent neurologic injury from respiratory compromise have been reported in children sedated with chloral hydrate; respiratory obstruction may occur in children with tonsillar and adenoidal hypertrophy, obstructive sleep apnea, and Leigh encephalopathy, and in ASA class III children; depressed levels of consciousness may occur; chloral hydrate should not be administered for sedation by nonmedical personnel or in a nonsupervised medical environment; sedation with chloral hydrate requires careful patient monitoring (Coté 2000). Animal studies suggest that chloral hydrate may depress the genioglossus muscle and other airway-maintaining muscles in patients who are already at risk for life-threatening airway obstruction (eg, obstructive sleep apnea); alternative sedative agents should be considered for these patients (Hershenson 1984).

Product Availability

Not available in the US

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Syrup, Oral:

Generic: 500 mg/5 mL (500 mL)

Administration: Adult

Oral: May dilute syrup in water or other oral liquid (eg, fruit juice, ginger ale) to minimize gastric irritation; administer 30 minutes prior to surgery/procedure.

Administration: Pediatric

Oral: Minimize unpleasant taste and gastric irritation by administering with water, infant formula, fruit juice, or ginger ale.

Use: Labeled Indications

Note: Not approved in the United States.

Procedural sedation: Sedative/hypnotic for surgery and diagnostic procedures.

Note: The manufacturer labeling includes indications for short-term treatment of insomnia; however, chloral hydrate is no longer recommended to be used this way (Schutte-Rodin 2008).

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (moderate and minimal sedation agent, oral, for children) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care and Community/Ambulatory Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

CNS Depressants: May increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification

Furosemide: May increase adverse/toxic effects of Chloral Hydrate/Chloral Betaine. Risk X: Avoid

HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Melatonin: May increase sedative effects of Hypnotics (Nonbenzodiazepine). Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Oxybate Salt Products: Hypnotics (Nonbenzodiazepine) may increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid

OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Vitamin K Antagonists: Chloral Hydrate/Chloral Betaine may increase serum concentration of Vitamin K Antagonists. Risk C: Monitor

Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification

Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification

Pregnancy Considerations

Animal reproduction studies have not been conducted. Chloral hydrate crosses the placenta, and long-term use may lead to withdrawal symptoms in the neonate.

Breastfeeding Considerations

Chloral hydrate is excreted in breast milk; use by breast-feeding women may cause sedation in the infant.

Monitoring Parameters

Vital signs, O2 saturation/respiratory function, BP, level of sedation, resedation (may persist up to 24 hours) (Grissinger 2019).

Mechanism of Action

Central nervous system depressant effects are due to its active metabolite trichloroethanol, mechanism unknown

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 15 to 30 minutes (Krauss 2006)

Duration: 1 to 2 hours (Krauss 2006)

Absorption: Oral: Well absorbed

Protein binding: Trichloroethanol: 35% to 40%; trichloroacetic acid: ∼94% (may compete with bilirubin for albumin binding sites)

Metabolism: Rapidly metabolized in the liver by alcohol dehydrogenase to trichloroethanol (active metabolite); trichloroethanol undergoes glucuronidation in the liver; variable amounts hepatically and renally to trichloroacetic acid (inactive)

Half-life elimination:

Chloral hydrate (Mayer 1991):

Preterm infants (postmenstrual age [PMA] 31 to 37 weeks): 1.01 ± 0.97 hours

Term infants (PMA 38 to 42 weeks): 3.01 ± 5.81 hours

Children and Adolescents <14 years: 9.68 ± 7.73 hours

Active metabolite (trichloroethanol) (Mayers 1991):

Preterm infants (PMA 31 to 37 weeks): 39.82 ± 14.27 hours

Term infants (PMA 38 to 42 weeks): 27.8 ± 21.32 hours

Children and Adolescents <14 years: 9.67 ± 1.72 hours

Adults: 8 to 12 hours (Fuhrman 2011)

Trichloroacetic acid: Adults: 67 hours (Furhman 2011)

Excretion: Urine (as metabolites); feces (small amounts)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Noctec;
  • (CH) Switzerland: Chloraldurat blau | Chloraldurat rot | Medianox;
  • (DE) Germany: Chloraldurat | Chloralhydrat;
  • (GB) United Kingdom: Chloral | Noctec;
  • (HK) Hong Kong: Chloral;
  • (IN) India: Chloral;
  • (JP) Japan: Escre aventis | Escre s.s. seiyaku;
  • (KR) Korea, Republic of: Pocral;
  • (NZ) New Zealand: Biomed Chloral Hydrate;
  • (PK) Pakistan: Apnotek;
  • (PR) Puerto Rico: Somnote;
  • (SG) Singapore: Chloral
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