In the U.S.—

In Canada—

• Sedative-hypnotic

Chloral hydrate (KLOR-al HYE-drate) belongs to the group of medicines called sedatives and hypnotics. It is sometimes used before surgery or certain procedures to relieve anxiety or tension or to produce sleep. If your child is to take this medicine before a dental or medical procedure, it should be given to the child only at the health care facility where the procedure is to be done. This will allow the health care professional to monitor your child.

Chloral hydrate has been used in the treatment of insomnia (trouble in sleeping) and to help calm or relax patients who are nervous or tense. However, this medicine has generally been replaced by other medicines for the treatment of insomnia and nervousness or tension.

Chloral hydrate has also been used with analgesics (pain medicine) for control of pain following surgery. However, this medicine has generally been replaced by other medicines for control of pain following surgery.

Chloral hydrate comes in different strengths. Serious problems, including deaths, have occurred when children were given the wrong strength. Make sure your doctor has told your pharmacist both how many milligrams (mg) and how many capsules, teaspoonfuls, or suppositories should be used. This information is needed to be sure the right amount is given.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S. and Canada)
• Syrup (U.S. and Canada)

Rectal
• Suppositories (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For chloral hydrate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to chloral hydrate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on birth defects have not been done in either humans or animals. Too much use of chloral hydrate during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth.

Breast-feeding—Chloral hydrate passes into the breast milk and may cause drowsiness in babies of mothers using this medicine.

Children—This medicine comes in different strengths. Serious problems, including deaths, have occurred when children were given the wrong strength. Make sure your doctor has told your pharmacist both how many milligrams (mg) and how many capsules, teaspoonfuls, or suppositories your child should receive. This information is needed to be sure the right amount is given. With proper use, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of chloral hydrate in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking chloral hydrate, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners)—Chloral hydrate may change the amount of anticoagulant you need to take

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Using these medicines and chloral hydrate together may increase the CNS and other depressant effects

• Alcohol abuse or dependence (or history of) or
• Drug abuse or dependence (or history of)—Dependence on chloral hydrate may develop

• Colitis or
• Proctitis or inflammation of the rectum—Chloral hydrate used rectally may make the condition worse

• Esophagitis or inflammation of the esophagus, or
• Gastritis or inflammation of the stomach, or
• Stomach ulcers—Chloral hydrate taken by mouth may make the condition worse

• Heart disease—Chloral hydrate may make the condition worse

• Kidney disease or
• Liver disease—Higher blood levels of chloral hydrate may occur, increasing the chance of side effects

• Porphyria—Acute attacks may be set off by chloral hydrate

• Sleep problems in children (especially in those with enlarged tonsils)—Risk of breathing problems may be increased

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much is used, it may become habit-forming.

For patients taking chloral hydrate capsules:

• Swallow the capsule whole. Do not chew since the medicine may cause an unpleasant taste.
• Take this medicine with a full glass (8 ounces) of water, fruit juice, or ginger ale to lessen stomach upset.

For patients taking chloral hydrate syrup:

• Take each dose of medicine mixed with clear liquid, such as water, apple juice, or ginger ale. This will help to improve flavor and lessen stomach upset.

For patients using chloral hydrate rectal suppositories :

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• To insert suppository–First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Dosing—

The dose of chloral hydrate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of chloral hydrate. If your dose is different, do not change it unless your doctor tells you to do so.

This medicine comes in different strengths. Make sure your doctor has told your pharmacist both how many milligrams (mg) and how many capsules, teaspoonfuls, or suppositories should be used. This information is needed to be sure the right amount is given.

The number of capsules or teaspoonfuls of syrup that you take, or suppositories that you use, depends on the strength of the medicine. Also, the number of doses you use each day, the time allowed between doses, and the length of time you use the medicine depend on the medical problem for which you are using chloral hydrate.

• For oral dosage form (capsules or syrup):
  • For trouble in sleeping or sedation before surgery:
    • Adults—500 to 1000 milligrams (mg) taken thirty minutes before bedtime or surgery.
  • For daytime sedation:
    • Adults—250 mg taken three times a day after meals.
  • For sedation before a dental or medical procedure:
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 mg per kilogram (kg) (23 mg per pound) of body weight.
  • For sedation before an electroencephalograph (EEG) test:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 25 mg per kg (11 mg per pound) of body weight.
• For rectal dosage form (suppositories):
  • For trouble in sleeping:
    • Adults—500 to 1000 mg at bedtime.
  • For daytime sedation:
    • Adults—325 mg three times a day.
  • For sedation before a dental or medical procedure:
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 mg per kg (23 mg per pound) of body weight.
  • For sedation before an electroencephalograph (EEG) test:
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 mg per kg (11 mg per pound) of body weight.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose of chloral hydrate is especially dangerous in children.
• Store away from heat and direct light.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the syrup form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you will be using this medicine regularly for a long time:

• Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.
• Do not stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of chloral hydrate or taking alcohol or other CNS depressants with chloral hydrate may lead to unconsciousness and possibly death. Some signs of an overdose are continuing confusion, difficulty in swallowing, convulsions (seizures), severe drowsiness, severe weakness, shortness of breath or troubled breathing, staggering, and slow or irregular heartbeat.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Skin rash or hives 
  
  

• Rare
  • Confusion;  hallucinations (seeing, hearing, or feeling things that are not there);  unusual excitement  
  
  

• Symptoms of overdose
  • Confusion (continuing);  convulsions (seizures);  difficulty in swallowing;  drowsiness (severe);  low body temperature ;  nausea, vomiting, or stomach pain (severe);  shortness of breath or troubled breathing;  slow or irregular heartbeat;  slurred speech;  staggering;  weakness (severe) 
  
  

Other side effects may occur that do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Nausea;  stomach pain;  vomiting 
  
  

• Less common
  • Clumsiness or unsteadiness;  diarrhea ;  dizziness or lightheadedness;  drowsiness;  ``hangover'' effect 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Confusion;  hallucinations (seeing, hearing, or feeling things that are not there);  nausea or vomiting;  nervousness;  restlessness;  stomach pain;  trembling;  unusual excitement 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.