Chloral Hydrate

Trade Names:
Chloral Hydrate
- Syrup 500 mg per 5 mL

Trade Names:
Somnote
- Capsules 500 mg

Pharmacology

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Exact mechanism is unknown; can produce mild CNS depression.

Pharmacokinetics

Absorption

Readily absorbed.

Distribution

35% to 41% protein bound (trichloroethanol). Excreted in breast milk.

Metabolism

Metabolized to trichloroethanol (active), which is then converted in liver and kidney to trichloroacetic acid (inactive).

Elimination

The half-life is 7 to 10 h (trichloroethanol). Metabolites are excreted in urine and bile.

Indications and Usage

Management of short-term insomnia; sedation; prevention or suppression of alcohol withdrawal symptoms; reduce anxiety associated with withdrawal of drugs such as narcotics or barbiturates; preoperatively or prior to electroencephalographic evaluation to allay anxiety and produce sedation and/or sleep.

Contraindications

Hypersensitivity to chloral derivatives; severe renal or hepatic function impairment.

Dosage and Administration

PO Capsules/Syrup: 500 mg to 1 g every 6 h if needed (max, 2 g daily).

PO Capsules/Syrup: 500 mg to 1 g 15 to 30 min before bedtime.

PO Syrup: 50 mg/kg/day (max, 1 g per dose) for sleep.

PO Syrup: 20 to 25 mg/kg.

PO Capsules/Syrup: 250 mg 3 times daily after meals.

PO Syrup: 8 mg/kg or 250 mg/m ² 3 times daily (max, 500 mg 3 times daily).

General Advice

Administer syrup or capsules with full glass of water or fruit juice to help prevent GI upset problems. Chilling of syrup may lessen its unpleasant taste.

Storage/Stability

Store at 59° to 86°F. Do not freeze.

Store at 68° to 77°F. Protect from light and freezing.

Drug Interactions

Additive CNS depression may occur. Rarely, disulfiram-like reactions may occur with alcohol ingestion.

Administration within 24 h of chloral hydrate may lead to diaphoresis, hot flashes, tachycardia, and hypertension.

Anticoagulant effects may be increased transiently.

May reduce effects of phenytoin.

Laboratory Test Interactions

May cause false-positive urine glucose test results with Benedict solution or cupric sulfide tablets (eg, Clinitest ), but not with enzyme-based tests (eg, Clinistix , Tes-tape ); altered urinary 17-ketosteroid values when using the Reddy, Jenkins, and Thorn procedure; false-positive phentolamine test results; results of fluorometric tests for urine catecholamines may be altered (do not administer chloral hydrate 48 h before this test).

Adverse Reactions

CNS

Ataxia; dizziness; residual sedation (“hangover effect”); somnambulistic reaction including disorientation and incoherence.

Dermatologic

Angioedema; bullous lesions; eczema; erythema multiforme; purpura; scarlatiniform or erythematous rash; urticaria.

GI

Diarrhea; gastric irritation; nausea; vomiting.

Miscellaneous

Fever.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy of capsules not established.

Hypersensitivity

Anaphylaxis and angioedema may occur as early as the first dose.

Special Risk Patients

Use with caution in patients who are depressed, have suicidal tendencies, or have a history of drug abuse.

Acute intermittent porphyria

Attacks may be precipitated in susceptible patients.

Drug dependency

May be habit forming. Use with caution in patients with history of drug or alcohol addiction. Withdraw drug slowly.

GI disorders

Avoid use in patients with esophagitis, gastritis, or gastric or duodenal ulcers.

Prolonged administration

Gastritis, skin eruptions, or parenchymatous renal damage may develop following prolonged administration. In addition, prolonged use may produce drug tolerance and physical and/or psychological dependence.

Skin/Mucous membrane irritation

Irritates skin and mucous membranes.

Sleep-related behavior

Behaviors may include sleep-driving as well as making phone calls and preparing and eating food while asleep.

Overdosage

Symptoms

Areflexia, cardiac arrhythmias, coma, death from respiratory failure or hypertension, esophageal stricture, gastric necrosis and perforation, GI hemorrhage, hepatic and renal function impairment with resulting transient jaundice and/or albuminuria, hypotension, hypothermia, miosis, muscle flaccidity, respiratory depression, vomiting.

Patient Information

• Instruct patient to take medication exactly as prescribed. Warn that taking doses too close together could result in overdose. Omit missed doses.
• Inform patient that effects of medication may not be noted until after 48 h.
• Advise patient that medication will be discontinued gradually to prevent withdrawal symptoms, including CNS excitation with tremor, anxiety, hallucinations, or delirium.
• Instruct patient to report these symptoms to health care provider: abdominal pains, GI problems, irregular heartbeats or palpitations, rash or unusual bleeding or bruising, visual changes, or yellowing of skin or eyes.
• Advise patient that drug may cause drowsiness or dizziness and to use caution when driving or performing other tasks requiring mental alertness.
• Caution patient to avoid intake of alcoholic beverages and other CNS depressants, such as barbiturates and narcotics.

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