© Copyright 1998 The United States Pharmacopeial Convention, Inc. All rights reserved.
USP DI and Advice for the Patient are registered trademarks of the United States Pharmacopeial Convention, Inc.
Glutethimide was introduced in 1954 as safe barbiturate substitute. Experience showed, however, that its addiction
liability and the severity of withdrawal
symptoms were similar to those of barbiturates.
In 1991, glutethimide was transferred into Schedule II in response to an upsurge in the prevalence of diversion, abuse and overdose deaths, making it an illegal substance in USA as well as a number of other countries. It is classified as a sedative-hypnotic.
Glutethimide (gloo-TETH-i-mide) is used to treat insomnia (trouble in sleeping). However, it has generally been replaced by safer and more effective medicines for the treatment of insomnia. If glutethimide is used regularly (for example, every day) to help produce sleep, it is usually not effective for more than 7 days.
[h4]Before Using This Medicine[/h4]
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 glutethimide the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to glutethimide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Studies of effects in pregnancy have not been done in either humans or animals. However, too much use of glutethimide during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth.
Glutethimide passes into the breast milk and may cause drowsiness in nursing babies.
Studies on this medicine have been done only in adult patients and there is no specific information comparing use of glutethimide in children with use in other age groups.
Elderly people may be especially sensitive to the effects of glutethimide. This may increase the chance of side effects
Although certain medicines should not be used together at all, in other cases 2 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 glutethimide it is especially important that your health care professional know if you are taking any of the following:
Anticoagulants (blood thinners)
Glutethimide may change the amount of anticoagulant you need to take.
Central nervous system (CNS) depressants
other (medicine that causes drowsiness) or
Tricyclic antidepressants (medicine for depression)
Using these medicines together with glutethimide may increase the CNS and other depressant effects
[h4]Other Medical Problems[/h4]
The presence of other medical problems may affect the use of glutethimide. Make sure you tell your doctor if you have any other medical problems, especially:
Enlarged prostate or
Intestinal blockage or
Irregular heartbeat or
Stomach ulcer or
Urinary tract blockage (it may make things worse)
Kidney disease (may increase the chance of side effects)
[h4]Proper Use of This Medicine[/h4]
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.
The dose of glutethimide 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 glutethimide. If your dose is different, do not change it unless your doctor tells you to do so.
For oral dosage (capsules or tablets):
Adults: 500 milligrams (1 capsule or tablet) at bedtime.
Children: Dose must be determined by the doctor.
To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
[h4]Precautions While Using This Medicine[/h4]
If you will be taking this medicine regularly for a long time:
Your doctor should check your progress at regular visits. Do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking 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. Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by 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 glutethimide or taking alcohol or other CNS depressants with glutethimide may lead to unconsciousness and possibly death.
Some signs of an overdose are continuing confusion, severe weakness, shortness of breath or slow or troubled breathing, convulsions (seizures), slurred speech, staggering, and slow heartbeat.
This medicine may cause some people to become dizzy, 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.
[h4]Side Effects Of This Medicine[/h4]
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:
Sore throat and fever; unusual bleeding or bruising; unusual excitement; unusual tiredness or weakness
[h4] Other Side Effects Of This Medicine[/h4]
Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:
Blurred vision; clumsiness or unsteadiness; confusion; dizziness; ``hangover'' effect; headache; nausea; vomiting
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:
Convulsions (seizures); fast heartbeat; hallucinations (seeing, hearing, or feeling things that are not there); increased dreaming; muscle cramps or spasms; nausea or vomiting; nightmares; stomach cramps or pain; trembling; trouble in sleeping.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Symptoms of overdose
Bluish coloration of skin; confusion (continuing); convulsions (seizures); fever; low body temperature; memory problems; muscle spasms or twitching; shortness of breath or slow or troubled breathing; slow heartbeat; slowness or loss of reflexes; slurred speech; staggering; trembling; trouble in concentrating; weakness (severe)
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