INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, the FDA has classified the indications as follows:
"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Final classification of the less-than-effective indications requires further investigation.
FDA BLACK-BOX WARNING
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
If you are currently taking zolpidem and develop complex sleep behaviors, discontinue the drug immediately and seek medical help.
Otherwise, if you have been taking zolpidem for awhile, do not stop taking this drug suddenly because it may cause drug-induced dependence. Instead, work with your doctor to create a schedule to stop it gradually to avoid withdrawal reactions (including stomach cramps, vomiting, nervousness and panic attacks).
The FDA has concluded that this drug lacks evidence of effectiveness.