ZOLPIDEM
Drugs in Pregnancy and Lactation.
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Name: ZOLPIDEM
Class: Hypnotic
Risk Factor: BM
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.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
Q&A about Zolpidem
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?
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?
* 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.
I know these are supposed to be sedatives, so I'm just wondering how people get addicted (if they do). Are there side effects?
* 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.
I know one is Generic and can be bought in other countries and the other is still holding a patent in the U.S,
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!
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?
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?
Hi, Looking for zolpidem to purchase on the internet. Does anyone know a decent website where I can buy this?
How long does it take to take effect? Does it make you drowsy the next day? Any other side effects?
Good luck with it! It does help me sleep where as I couldn't before.
And route of administration?
1) will I go high?
2) will I have a physical/aesthetic effect?
3) or will I just have a good night if sleep? (like 7-8 hours)
Well I got really messed up. Blood pressure went way up etc.