Flurazepam

 Risk Factor: XM
 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

Flurazepam is a benzodiazepine used to induce sleep. No teratogenic or other adverse fetal or postnatal effects were observed in studies using rats and rabbits administered 80 mg/kg and 20 mg/kg, respectively, during various stages of gestation (1). Similarly, no reports of congenital abnormalities attributable to human exposure with flurazepam have been located. One group of investigators classified the risk to the fetus from exposure to flurazepam as none-minimal, but the quality of the data was judged to be poor. (2) Studies involving other members of this class, however, have found evidence that some of these agents may cause fetal abnormalities (see Chlordiazepoxide and Diazepam).

Although published data are lacking, the low molecular weight of flurazepam (approximately 461) suggests it is transferred to the fetus. Data from the manufacturer indicate that an active metabolite of flurazepam crosses the human placenta and may adversely affect the newborn (3). In a case cited in their product information, a woman ingested flurazepam, 30 mg nightly, for 10 days immediately preceding delivery. The newborn appeared sleepy and lethargic during the first 4 days of life. The effect was thought to be due to a long-acting metabolite, N1-desalkylflurazepam, found in the newborn's serum.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 73 newborns had been exposed to flurazepam during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Four (5.5%) (3 expected) major birth defects were observed, including (observed/expected) 2/1 cardiovascular defects, 1/0 oral clefts, and 1/0 polydactyly. These data do not support an association between the drug and congenital defects.

A brief 1982 case report described convulsions attributable to clomipramine in a newborn who was exposed to that drug and flurazepam throughout gestation (4). The 2360-g male infant was delivered vaginally at 33 weeks' gestation (the reason for the premature delivery was not stated) and had Apgar scores of 9 and 9 at 1 and 5 minutes, respectively. Convulsions, consisting of myoclonic jerks that were unresponsive to phenobarbital, started at 7 hours of age and were eventually successfully treated with IV and oral clomipramine, although the infant remained jittery. The contribution of flurazepam, which is known to cause convulsions after abrupt withdrawal following prolonged use in adults, to the seizures observed in the newborn is unknown. However, a correlation between declining serum levels of clomipramine and its active metabolite and the condition of the infant probably indicates that the seizures were not due to flurazepam.

Breast Feeding Summary

Studies examining the excretion of flurazepam into breast milk have not been located. However, the passage of this agent and its active, long-acting metabolite into milk should be expected (see also Diazepam). The American Academy of Pediatrics classifies other benzodiazepines, such as diazepam, as agents whose effects on the nursing infant are unknown, but they may be of concern (5).

References

1. Hoffmann-LaRoche Company, personal communication, 1979. As cited by Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD: Johns Hopkins University Press, 1989:285.
2. Friedman JM, Little BB, Brent RL, Cordero JF, Hanson JW, Shepard TH. Potential human teratogenicity of frequently prescribed drugs. Obstet Gynecol 1990;75:5949.
3. Product information. Dalmane. Roche Laboratories, 1993.
4. Cowe L, Lloyd DJ, Dawling S. Neonatal convulsions caused by withdrawal from maternal clomipramine. Br Med J 1982;284:18378.
5. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
   
   

Questions and Answers

I just took one flurazepam (pill for sleep) and drank alcohol, am i gonna die?,

I'm assuming you took lorazepam (Ativan)...which is a short-term benzodiazepine (the effects wear off quicker than diazepam...or Valium). If you are not dead already, you are not going to die ;) ...but like the other posters said, you're going to sleep pretty hard. Two depressants = stronger effects. Don't scare yourself again...keep the two separate...

what does flurazepam actually treat for besides insomnia? Does it work for sleep very good? thnks?,

This class of drugs (benzodiazepines) are not intended for anything beyond 1-2 week usage. After that, you are doing yourself more harm than good.

No drug can induce a good nights sleep. Period.

what are Amobarbital, Butabarbital,Codeine, Flurazepam,Gluthethimide,Chloral Hydrate,Hydromorphone,Meprobamate?, what is the meaning of Amobarbital, Butabarbital,Codeine, Flurazepam,Gluthethimide,Chloral Hydrate,Hydromorphone,Meprobamate,Meperi...

I don't understand what you are trying to find out. The only thing I can tell you is that butalbital and codeine are ingredients in a common tension headache remedy, Fiorinal (I don't know its european name though). You might want to take advantage of the database on http://www.webmd.com for more information.

What is the difference between Clonazepam, Flurazepam, and Lorazepam?, What is the difference between Clonazepam, Flurazepam, and Lorazepam and how do they react with Norco?

I had Spinal Fusion Surgery 10 days ago and have been taking the Fentanyl 100 mcg/hr patch and Norco 10/325 every 4 hours for severe pain and 2 tabs of 0.5 Ativan to help me sleep at night.

I'm out of Ativan and have a few capsules of Clonazepam, Flurazepam, and Lorazepam and want to know which is the most useful to combat my late night insomnia and early wake-up.

Thanks.

Lorazepam IS Ativan. It is also the only one of those three that I would recommend for short-term insomnia.

Clonazepam has a much weaker sedative effect, and Flurazepam has a very lengthy duration of action (nearly 4 days!), so you will still be extremely drowsy the next day.

Just be careful though, since Lorazepam has a high potential for addiction.