With food, mean AUC and Cmax were decreased while fasting or 20 minutes after a meal. Concomittant administration of zolpidem with alcohol should be avoided because of the possibility of enhanced sedative action Rifampicin, potent inducer of CYP enzymes, significantly reduces the plasma concentration and effects of zolpidem
LIST OF DRUGS DURING 2006
Name of the Drug- Zolpidem Tartrate ER tablet (6.25mg/12.5mg) Pharmacological Classification- For insomnia
Date of Approval- 10-07-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
Insomnia- short term treatment
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Zolpidem tartrate Sedative -Insomnia 28-05-1999
2.Zolpidem Tartrate For Insomina 10-07-2006
E.R tablet 6.25mg/12.5mg
ZOLPIDEM - RISK OF NEXT DAY TRAFFIC ACCIDENTS
The U.S. Food Drug Administration (USFDA ) issued a much -delayed safety alert concerningnext-day sleepiness and the risk of traffic accidents caused by a group of drugs containing zolpidem (sold as NIDRA, ZLEEP etc. in India).
The USFDA had received approximately 700 reports of driving mishaps since zolpidems original approval.
The USFDA before approval of the drug in November 2011, had twice rejected approval of the drug precisely because of these same concerns about high levels of the drug remaining in the blood the moring after the drug is taken and this fact contributing to car accidents. Other problems with zolpidem result from next-day memory loss of activities performed the night before ( texting,eating etc.)
In the 2011 approval process for the drug , the USFDA was aware of the higher levels of the drug in the womens blood, and the agency thus required a lower dose for women.
However, one of the characterstics of zolpidem is that there is a tremandrous individual variation in how it is metabolized, meaning it is almost impossible to predict the level of the drug in a given inidividuals blood, how long the drug will stay in the body, and thus how any one individual will respond. (MIMS ).
Drowsiness, amnesia, dizziness, headache, nausea and vomiting
Hypersensitivity In conditions such as obstructive sleep apnea, Myasthenia gravis, severe hepatic insufficiency, acute pulmonary insufficiency and respiratory depression
Respiratory depression, renal functional impairment, depression- administer with caution Safety and efficacy of the drug in neonates, children, mothers, pregnancy are available but the use is not recommended Use with caution in patients exhibiting signs of depression. Drug to be administered immediately prior to going to bed, because of rapid onset of action. Patients are warned from doing any jobs involving mental alertness or motor co-ordination after ingestion of the drug.
Dosages/ Overdosage Etc:
Insomnia- short term treatment
Dosage: Adults- individualise dose. Usual 10mg immediately before bed time
1.May cause drowsiness; use caution when performing tasks requiring
alertness, coordination or physical dexterity.
2. Avoid alcohol and CNS depressants while taking the drug.
Tell your doctor if you had any unusual or allergic reactions to Zolpidem.
Tell your doctor if you are allergic to any other substances such as foods,
Zolpidem has not been studied in pregnant women. However studies in
pregnant animals shown that zoplidem slows down the development
of offspring when given to mothers in doses many times the human dose.
Before taking this medicine make sure your doctor knows if you are pregnant
or you may become pregnant
5. Breast feeding-
Although zolpidem passes into breast milk it has not been reported to
cause problems in nursing babies
Studies on this medicine have done only in adult patients and there is no
specific information comparing zolpidem in children with use in older
7. Older adults-
Confusion and falling are more likely to occur in the elderly, who are
usually more sensitive than younger adults to the effects of zopidem
8. Other medicines-
Tell your doctor if you are taking any of the following-
Other CNS depressant drugs or
Tricyclic antidepressants - the CNS depressant effects of either these
medicines or zoplidem may be increased possibly leading to
9. Other medical problems-
Tell your doctor if you are having any of the following medical problems-
Alcohol abuse or
Drug abuse or dependence - dependence on zolpidem may develop
Emphysema- asthma ,bronchitis or other chronic lung disease or
Mental depression or
Sleep apnea - zolpidem my make these conditions worse
Kidney disease or
Liver disease -higher blood levels of zolpidem may result , increasing
the chance of side effects
10. Mixed dose-
If you are taking this medicine regularly and miss a dose
and go back to your regular dosing schedule. Do not double doses.
11. Storage -
Keep out of reach of children. Store away from heat or direct sunlight.
Do not store the capsule in bathroom, near the kitchen sink, or in other
17. Outdated medicines -
Do not keep outdated medicine or medicine no longer needed. Be sure
that any discarded medicine is out of reach of children.
Zolpidem is anon-benzodiazepine hypnotic of the imidazopyridine class.It interacts with a GABA-BZ receptor complex and shares some of the pharmocological properties of the benzodiapines.
It is rapidly absorbed from the GI tract and a short elimination half-life in healthy subjects. The half-life,bioavailability of Cmax of Zolpidem are increased in elderly patients with hepatic function impairment . Food decreases the bioavailability.
Interaction with Food:
With food, mean AUC and Cmax were decreased while fasting or 20 minutes after a meal. Food decreases bioavailability.
Pregnancy and lactation:
No adequate and well controlled studies in pregnant women. Excercise caution while administering to pregnant women.
Lactation: Use of Zolipem in nursing mothers not recommended.