Zolpidem
Risk Factor: BM
Class: CENTRAL NERVOUS SYSTEM DRUGS
/ Sedatives and Hypnotics
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Zolpidem is a nonbenzodiazepine hypnotic of the imidazopyridine class. In subjects with normal liver function, a single 5-mg dose zolpidem had a relatively short elimination half-life (2.6 hours, range 1.44.5 hours) (1).
In reproductive studies in rats no teratogenic effects were observed, but dose-related toxicity was observed in the fetuses (delayed maturation as characterized by incomplete ossification of the skull) at doses of 20 and 100 mg base/kg (1). The no-effect dose (4 mg base/kg) was 5 times the maximum human dose on a mg/m2 basis (MHD). In rabbits, increased postimplantation fetal loss and incomplete ossification of the sternum in surviving fetuses were observed at 16 mg base/kg, both possibly related to reduced maternal weight gain (1). The no-effect dose in rabbits was 4 mg base/kg (7 times the MHD). No teratogenic effects of the drug were observed. Shepard reviewed a reproductive toxicity study in rats during organogenesis that found no teratogenicity, but did observe a decrease in fetal weight at doses ranging from 5 to 125 mg/kg and an increase in wavy ribs at the highest dose (2).
It is not known if zolpidem crosses the human placenta. The molecular weight (about 765 for the tartrate salt) is low enough, however, that embryo/fetal exposure to the drug should be expected.
The FDA did not receive any reports of adverse fetal or newborn outcomes from pregnancy exposures to zolpidem between its approval in December 1992 and 1996 (personal communication, F. Rosa, FDA, 1996).
A 1998 noninterventional observational cohort study described the outcomes of pregnancies in women who had been prescribed one or more of 34 newly marketed drugs by general practitioners in England (3). Data were obtained by questionnaires sent to the prescribing physicians 1 month after the expected or possible date of delivery. In 831 (78%) pregnancies, a newly marketed drug was thought to have been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Zolpidem was taken during the 1st trimester in 18 pregnancies. The outcomes of these pregnancies included two spontaneous abortions, six elective abortions and 11 normal, term infants (one set of twins) (3).
Although no congenital malformations were observed in the above study, the data are too limited to assess the safety of zolpidem in the human embryo or fetus. Moreover, the study lacked the sensitivity to identify minor anomalies because of the absence of standardized examinations. Late-appearing major defects may also have been missed due to the timing of the questionnaires. Further, chronic maternal use of sedatives/hypnotics has been associated with withdrawal symptoms in newborns.
Breast Feeding Summary
Zolpidem is excreted into human breast milk, but the effects, if any, on a nursing infant have not been studied. In a 1989 report, five lactating women were administered a single 20-mg dose 34 days after delivery of a full-term infant (4). Breast feeding was halted for 24 hours after drug administration. Milk and serum samples were collected before and 1.5 (serum only), 3, 13, and 16 hours after the dose. The total amount of zolpidem in milk at 3 hours (both breasts emptied with an electric breast pump and the milk pooled for each woman) ranged from 0.76 to 3.88 g, representing 0.004%0.019% of the dose. The drug was not detected in milk (detection level 0.5 ng/mL) at the other sampling times. The dose used in this study is twice the current maximum recommended human hypnotic dose.
In healthy adult patients, zolpidem has a relatively short serum half-life (about 2.6 hours) and accumulation is not expected to occur. The small amount of drug measured in milk after a dose that was twice the recommended human dose probably indicates that few, if any, adverse effects would occur in a nursing infant whose mother was consuming this hypnotic. In those instances in which the mother is taking zolpidem, however, she should observe her nursing infant for increased sedation, lethargy, and changes in feeding habits. Based on the one study above, the American Academy of Pediatrics considers zolpidem to be compatible with breast feeding (5).
References
- Product information. Ambien. G.D. Searle, 2000.
- Shepard TH. Catalog of Teratogenic Agents. 8th ed. Baltimore, MD: Johns Hopkins University Press, 1995:231.
- Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998;105:8829.
- Pons G, Francoual C, Guillet Ph, Moran C, Hermann Ph, Bianchetti G, Thiercelin J-F, Thenot J-P, Olive G. Zolpidem excretion in breast milk. Eur J Clin Pharmacol 1989;37:2458.
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Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
Questions and Answers
Am addicted to sleeping pills(zolpidem tartrate), wont get sleep without it. How do I get out of this?, I also have pills for depression ( imipramine) along with sleeping pills. Its going on from past 2 months. Am now addicted to the sleeping pill. How can I kick this addiction?
Not late, only two months have passed. you are already taking anti-depressant [imipramine], so some time in case of poor sleep or no sleep in Depression, Psychiatrist add this type of medicine to have good sleep in night, nothing to worry, they do it for a short period and then gradually withdraw it. Go to your psychiatrist and ask that you want to leave this medicine, he will do it for you, he knows you and your problem so he will be a better adviser.
What is the difference between Zolpidem Tartrate and Zolpidem?, I know one is Generic and can be bought in other countries and the other is still holding a patent in the U.S,
Zolpidem is the generic form of Ambien.
There is an ER (extended release) form known as Ambien CR (controlled release).
"tartrate" is just a term describing the "form" the drug comes in. Zolpidem (Ambien) comes as a tablet in tartrate form (in a salt form). I believe the tartrate form is the only form zolpidem and Ambien are manufactured...at least in the U.S.
Thus Zolpidem and Zolpidem Tartrate are exactly the same thing and have the exact same effect on the body.
Now then:
In the U.S., only Ambien is available...the brand name, and this by prescription only. It is a Schedule IV drug, too...so the prescription can only be written by a practitioner with a DEA number (Drug Enforcement Agency). This is because it is potentially addictive and has high abuse potential.
Outside the U.S., the generic form of Ambien is available....and this is called zolpidem (typically the Brand name is capitalized and the generic name is not, but this notation is not always followed by everybody).
All brand name drugs can eventually be sold as the generic in the U.S. (if another competing company should so choose to manufacture it), after a certain number of years...and perhaps that will happen with Ambien in the future.
But for all practical purposes:
Ambien = Zolpidem = Zolpidem Tartrate
Hope this helps!
Is it possible to be addicted to Zolpidem or Ambien?, I know these are supposed to be sedatives, so I'm just wondering how people get addicted (if they do). Are there side effects?
The people who get addicted to Zolpidem are those who fight the sedative effects of the drug and thus manage to experience euphoria. Some side effects are as follows:
* impaired reasoning and judgment
* delusions
* uninhibition in interpersonal or social settings
* hallucinations
* heightened impulsivity
* poor motor coordination
* decreased libido
* when intake is stopped, rebound insomnia is likely to occur
* loss of memory for events immediately following a trauma
* intensified appetite
When taken for long periods of time, the use of Ambien or Zolpidem may also lead to dependence.
Is it possible that Zolpidem causes mouth or body odor?, I take Zolpidem (Ambien) periodically for insomnia. Lately, my wife has mentioned that I have an unusual odor coming from my body. Since I've been using the drug a bit more than normal these days, I was wondering if it could be causing this problem?
I have noticed this with numerous pharmaceuticals and my partner. It is definitely possible for a pharmaceutical to alter your body chemistry in a way that significantly changes your odor. I at one point made him stop taking a high blood pressure medication because it literally made me sick to be near him. After two years without treatment (and I should mention low blood pressure readings for the entire time) a doctor put him on a different type of high blood pressure pill, which, thus far, has not had the same side effect. We had the same go around with an anti-depressant.
What are the side effects of taking Zolpidem or Ambien?, I have heard that people can get addicted to these kinds of drugs. I'm just wondering why and how they can get addicted to this. Do they feel a rush of euphoria? Aren't these supposed to be sedatives?
Yes, these are indeed sedatives. However, there are people who fight the sedative effects of the drug and thus manage to feel the side effect of experiencing euphoria. Other side effects are as follows:
* delusions
* hallucinations
* impaired reasoning and judgment
* uninhibition in interpersonal or social settings
* heightened impulsivity
* intensified appetite
* decreased libido
* poor motor coordination
* when intake is stopped, rebound insomnia is likely to occur
* loss of memory for events immediately following a trauma
When taken for long periods of time, the use of Ambien or Zolpidem may also lead to dependence.
Where can I find the best online site to buy generic Ambien (Zolpidem Tartrate) without a prescription?, The best price I can seem to find for 10mg pills seems to be a little over $2 per pill. Anybody know where I can find a better price?
taking prescription drugs without a prescription is stupid and illegal also anywhere you can get them without a prescription is shady and may not even be the right drug. if you want it go to a DR tell them you cant sleep its not to hard
Where is the best place to buy zolpidem on the internet (uk delivery)?, Hi, Looking for zolpidem to purchase on the internet. Does anyone know a decent website where I can buy this?
There isn't a 'best' place. You should only get in on prescription. If you think you need it, go and see your doctor. It is illegal to get prescription drugs from other sources and dangerous too! They are prescription only for a reason!
what is the shelf life of zolpidem?, I have a prescription that was issued on 6/13/2007, its expiration date is 6/13/2008. I was wondering if it still be okay to use even though it is 6 months past exp?
Most p/o (by mouth) medications other than liquid are good up to 1 year after the date printed on the prescription bottle.
Is anybody taking zolpidem tartrate sleeping tablets?, How long does it take to take effect? Does it make you drowsy the next day? Any other side effects?
Yes, I take it, it is the generic for Ambian. It seems to take affect for me from 1 to 1 1/2 hours after I take it. It does cause me to be very sleepy the next day especially if I don't take it early enough the night before. I try to take it where I can be in bed for at least a solid 8 hrs AFTER it kicks in (before 9 in my case) to eliminate the sleepies. Another thing I have noticed is it makes me hungry when it starts to take effect, here I am supposed to be going to sleep and I need a nite-nite snack! LOL
Good luck with it! It does help me sleep where as I couldn't before.
What is the doze of zolpidem in vegatative state?, And route of administration?
Um in a vegitative state it would be administered vie IV and does would vary
