Ethchlorvynol (Oral route)
Uses of This Medicine:
Ethchlorvynol is used to treat insomnia (trouble in sleeping). However, it has generally been replaced by other medicines for the treatment of insomnia. If ethchlorvynol is used regularly (for example, every day) to help produce sleep, it is usually not effective for more than 1 week.
This medicine is available only with your doctor's prescription.
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:
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.
Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ethchlorvynol in children with use in other age groups.
Elderly people may be especially sensitive to the effects of ethchlorvynol. This may increase the chance of side effects during treatment.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Sodium Oxybate
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.
- Morphine Sulfate Liposome
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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 history of) or
- Drug abuse or dependence (or history of)—Dependence on ethchlorvynol may develop
- Kidney disease or
- Liver disease—Higher blood levels of ethchlorvynol may result and increase the chance of side effects
- Mental depression or
- Porphyria—Ethchlorvynol may make the condition worse
Proper Use of This Medicine:
Ethchlorvynol is best taken with food or a glass of milk to lessen the possibility of dizziness, clumsiness, or unsteadiness, which may occur shortly after you take this medicine.
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 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.
- For oral dosage forms (capsules):
- Adults: 500 to 1000 milligrams at bedtime.
- Children: Dose must be determined by the doctor.
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 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 cause 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 taking 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 ethchlorvynol or taking alcohol or other CNS depressants with ethchlorvynol 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, slurred speech, staggering, and slow 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.
- Less common
- Skin rash or hives
- dizziness or faintness
- unusual excitement, nervousness, or restlessness
- Darkening of urine, itching, pale stools, yellow eyes or skin
- unusual bleeding or bruising
- Symptoms of overdose
- confusion (continuing)
- decrease in or other change in vision
- double vision
- fever, chills, or sore throat
- low body temperature
- numbness, tingling, pain, or weakness in hands or feet
- overactive reflexes
- pale skin
- shakiness and unsteady walk, clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination
- shortness of breath or slow or troubled breathing
- slow heartbeat
- slurred speech
- unusual bleeding or bruising
- unusual movements of the eyes
- unusual tiredness or weakness (severe)
Check with your doctor as soon as possible if any of the following side effects occur:
- More common
- Blurred vision
- dizziness or light-headedness
- low blood pressure
- nausea or vomiting
- numbness of face
- stomach pain
- unpleasant aftertaste
- unusual tiredness or weakness
- Less common
- Clumsiness or unsteadiness
- drowsiness (daytime)
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:
- Confusion as to time, place, or person
- convulsions (seizures)
- hallucinations (seeing, hearing, or feeling things that are not there)
- loss of appetite
- memory loss
- muscle twitching
- nausea or vomiting
- restlessness, nervousness, or irritability
- slurred speech
- trouble in sleeping
- weight loss, unexplained
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:
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.
Last Updated: 6/18/2019