Pronunciation:

KLOR-al HYE-drate

Brand Names:

• Aquachloral Supprettes
• Somnote

Dosage Forms:

• Suppository
• Syrup
• Capsule, Liquid Filled

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Uses of This Medicine:

Chloral hydrate 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 However, this medicine has generally been replaced by other medicines for the treatment of insomnia and nervousness or tension.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 However, this medicine has generally been replaced by other medicines for control of pain following surgery.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 was available only with your doctor's prescription.

Products containing chloral hydrate have been voluntarily withdrawn from the U.S. market. The oral solution was withdrawn on May 25, 2012 for business reasons. The oral capsules were withdrawn on January 14, 2013 due to supply issues. The rectal suppositories have also been withdrawn.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Levomethadyl
• Mesoridazine
• Pimozide
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Adinazolam
• Ajmaline
• Alfentanil
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Amobarbital
• Amoxapine
• Anileridine
• Aprindine
• Aprobarbital
• Arsenic Trioxide
• Astemizole
• Azimilide
• Bretylium
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carbinoxamine
• Carisoprodol
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Desipramine
• Diazepam
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Droperidol
• Enflurane
• Erythromycin
• Estazolam
• Fentanyl
• Flecainide
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Foscarnet
• Fospropofol
• Furosemide
• Gemifloxacin
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Ibutilide
• Imipramine
• Isoflurane
• Isradipine
• Ketazolam
• Levorphanol
• Lidoflazine
• Lorazepam
• Lorcainide
• Lormetazepam
• Meclizine
• Medazepam
• Mefloquine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Methotrexate
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Nordazepam
• Nortriptyline
• Octreotide
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentamidine
• Pentobarbital
• Phenobarbital
• Pirmenol
• Prajmaline
• Prazepam
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Propoxyphene
• Quazepam
• Quinidine
• Remifentanil
• Risperidone
• Secobarbital
• Sematilide
• Sertindole
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sultopride
• Tedisamil
• Telithromycin
• Temazepam
• Terfenadine
• Thiopental
• Triazolam
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Vasopressin
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Perampanel
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

Proper Use of This Medicine:

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

• For oral dosage form (capsules or syrup):
  • For trouble sleeping or sedation before surgery:
    • Adults—500 to 1000 milligrams (mg) taken 30 minutes before bedtime or surgery.
  • For daytime sedation:
    • Adults—250 milligrams (mg) taken 3 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 milligrams (mg) per kilogram (kg) 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 milligrams (mg) per kilogram (kg) of body weight.
• For rectal dosage form (suppositories):
  • For trouble sleeping:
    • Adults—500 to 1000 milligrams (mg) at bedtime.
  • For daytime sedation:
    • Adults—325 milligrams (mg) 3 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 milligrams (mg) per kilogram (kg) 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 milligrams (mg) per kilogram (kg) 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

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 .

Side Effects of This Medicine:

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

seeing, hearing, or feeling things that are not there

unusual excitement

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nausea

stomach pain

vomiting

Less common

Clumsiness or unsteadiness

diarrhea

dizziness or lightheadedness

drowsiness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Confusion

nausea or vomiting

nervousness

restlessness

seeing, hearing, or feeling things that are not there

stomach pain

trembling

unusual excitement

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.