• Sedative-hypnotic

Ethinamate (e-THIN-a-mate) is used to treat insomnia (trouble in sleeping). However, it has generally been replaced by other medicines for the treatment of insomnia. If ethinamate is used regularly (for example, every day) to help produce sleep, it is usually not effective for more than 7 days.This medicine is not available in the U.S. or Canada.

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 ethinamate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ethinamate. 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.

Breast-feeding—It is not known whether ethinamate passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information about its use in children.

Older adults—Elderly people may be especially sensitive to the effects of ethinamate. This may increase the chance of side effects during treatment.

Other medicines—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 taking ethinamate it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants, other—Using these medicines together may increase the CNS and other depressant effects

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

• Mental depression—Ethinamate may make the condition worse

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.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose of ethinamate is especially dangerous in 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.

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 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 ethinamate or taking alcohol or other CNS depressants with ethinamate may lead to unconsciousness and possibly death. Some signs of an overdose are 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 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 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;  unusual excitement (especially in children) 
  
  

• Rare
  • Unusual bleeding or bruising 
  
  

• Symptoms of overdose
  • Confusion;  shortness of breath or slow or troubled breathing;  slow heartbeat;  slurred speech;  staggering;  weakness (severe) 
  
  

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:

• Less common
  • Indigestion;  nausea;  stomach pain;  vomiting 
  
  

• Rare
  • Drowsiness (daytime) 
  
  

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;  convulsions (seizures);  hallucinations (seeing, hearing, or feeling things that are not there);  restlessness, nervousness, or irritability ;  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.