Placidyl (Oral)

Ethchlorvynol is used to treat insomnia (trouble sleeping). However, it has mostly been replaced by other medicines for treating insomnia. If you use ethchlorvynol regularly (for example, every day) to help you sleep, it usually will not be effective for more than 1 week.

This medicine is available only with your doctor's prescription.

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.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it will provide. Here are some important considerations for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adults, and there is no specific information comparing the use of ethchlorvynol in children to other age groups.

Geriatric

Older adults may be more sensitive to the effects of ethchlorvynol, which could increase the risk of side effects during treatment.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are noted based on their potential significance and are not a complete list.

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

• Calcium Oxybate
• Magnesium Oxybate
• Potassium Oxybate
• Sodium Oxybate

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Aprobarbital
• Benzhydrocodone
• Brofaromine
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clorgyline
• Codeine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Doxylamine
• Esketamine
• Estazolam
• Fentanyl
• Flibanserin
• Flunitrazepam
• Flurazepam
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Hydrocodone
• Hydromorphone
• Iproniazid
• Isocarboxazid
• Ketamine
• Ketazolam
• Lacosamide
• Lazabemide
• Lemborexant
• Levocetirizine
• Levorphanol
• Linezolid
• Lofexidine
• Lorazepam
• Lormetazepam
• Loxapine
• Meclizine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nialamide
• Nitrazepam
• Olanzapine
• Oxazepam
• Oxycodone
• Oxymorphone
• Pargyline
• Pentazocine
• Pentobarbital
• Periciazine
• Phenelzine
• Phenobarbital
• Prazepam
• Pregabalin
• Primidone
• Procarbazine
• Quazepam
• Rasagiline
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selegiline
• Tapentadol
• Temazepam
• Thiopental
• Toloxatone
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Zolpidem
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken close to mealtimes or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Alcohol abuse (or a history of) or
• Drug abuse or dependence (or a history of)—Dependence on ethchlorvynol may develop

• Kidney disease or
• Liver disease—Higher blood levels of ethchlorvynol may occur and increase the chance of side effects

• Mental depression or
• Porphyria—Ethchlorvynol may worsen the condition

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• Dizziness or faintness
• Unusual excitement, nervousness, or restlessness

Rare

• 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
• Trembling
• Unusual bleeding or bruising
• Unusual movements of the eyes
• Unusual tiredness or weakness (severe)

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. 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

• Blurred vision
• Dizziness or light-headedness
• Low blood pressure
• Indigestion
• Nausea or vomiting
• Numbness of face
• Stomach pain
• Unpleasant aftertaste
• Unusual tiredness or weakness

Less common

• Clumsiness or unsteadiness
• Confusion
• Drowsiness (daytime)

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

• Confusion as to time, place, or person
• Convulsions (seizures)
• Dizziness
• 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
• Sweating
• Trembling
• Trouble sleeping
• Weakness
• Unexplained weight loss

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.

In the U.S.

• Placidyl

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.

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.

• For oral dosage forms (capsules): Adults: 500 to 1000 milligrams at bedtime. Children: Dose must be determined by the doctor.

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.