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PubMed1984

A double-blind comparison of two benzodiazepine hypnotics, flunitrazepam and triazolam, in general practice.

A double-blind study was carried out in 312 patients seen by their general practitioner for a sleep disorder requiring hypnotic treatment to compare the efficacy and event profile of flunitrazepam and triazolam. Patients were allocated at random to receive a night-time dose of 1 mg flunitrazepam or 0.25 mg triazolam for a minimum of 7 and a maximum of 14 nights. Sleep disturbances, classified as difficulty in falling asleep, troublesome awakenings in the first or the second half of the night, and early morning awakening, were assessed on the initial and final visits and details of any events recorded. The results showed no significant difference between the two treatments with respect to efficacy and event profile and the findings are discussed in the context of the differing pharmacokinetics of the two drugs.

Adolescent↗
PubMed1995

Double-blind comparison of zopiclone and flunitrazepam in elderly insomniacs with special focus on residual effects.

In a double-blind study of 102 patients with a mean age of 79 years, zopiclone was compared to flunitrazepam. The patients rated their sleep in a diary. There was no statistically significant difference between the relatively low dose of 5 mg zopiclone and 1 mg flunitrazepam for eleven out of the twelve variables measuring subjective sleep quality and quantity. There was no differences between the drugs as regards patients' feelings of being rested or alertness.

Aged↗
PubMed2003

CCK-8 modulates GABA-stimulated [3H]-flunitrazepam binding in vitro.

In membranes from rat cerebral cortex, cholecystokinin-8 (CCK-8) did not modulate basal [(3)H]-flunitrazepam binding at either 4 degrees C or 37 degrees C. At a concentration of 10(-6) M, CCK(-8) significantly decreased gamma-amino-butyric acid (GABA)-stimulated (10(-6) M) [(3)H]-flunitrazepam binding at 37 degrees C. Scatchard analyses suggest that the decreased GABA-stimulated binding might be due to a decrease in the affinity of benzodiazepine receptors rather than to a decrease of number of binding sites. The observed modulation of benzodiazepine receptors by CCK-8 in vitro might explain some of the functional interactions between CCK and benzodiazepine systems.

Animals↗
PubMed2000

[Abuse of flunitrazepam in opioid addicts].

Fifty-three heroin addicts, nineteen of them methadone treated, were asked about their use of flunitrazepam. Drug abuse began after a medical prescription in 50% of cases; flunitrazepam was taken per os, but also i.v. in 19% of cases. The mean daily dose was about 20 mg/day, often associated with other psychotropic drugs, alcohol, opiates or cocaine. Attention is focused on the amnesia and increased feeling of power (11% of cases), often resulting in serious violent offenses.

Adolescent↗
PubMed2000

Acute benzodiazepine withdrawal delirium after a short course of flunitrazepam in an intensive care patient.

Acute benzodiazepine and opioid withdrawal syndromes are increasingly described in intensive care unit patients. There is often some difficulty in distinguishing between the respective responsibilities of the sedative and analgesic agents. We report a case of acute benzodiazepine withdrawal delirium after a short course of flunitrazepam in an intensive care patient. Flunitrazepam was administered because of institution of mechanical ventilation. Recent data on the incidence and risk factors of the syndrome in intensive care unit patients are presented. Criteria for diagnosis and therapeutic guidelines are discussed.

Acute Disease↗
PubMedDate not supplied

[Fatal outcome of poisoning with the benzodiazepines flunitrazepam and diazepam].

On a wintry day a 29-year-old woman was found dead beside her car showing head injuries and signs of hypothermia. Several empty packets of sedative and hypnotic drugs were lying inside the car. Toxicological analysis revealed the presence of flunitrazepam (heart blood of the left and right chamber 0.033 mg/L each), norflunitrazepam (left heart blood 0.029 mg/L, right heart blood 0.027 mg/L), 7-amino-flunitrazepam (left heart blood 0.090 mg/L, right heart blood 0.104 mg/L), diazepam (left heart blood 0.395 mg/L, right heart blood 0.386 mg/L), nordazepam (left heart blood 0.112 mg/L, right heart blood 0.115 mg/L) and temazepam (left heart blood 0.034 mg/L, right heart blood 0.033 mg/L). Neither alcohol nor other drugs were found. It was concluded that benzodiazepine intake led to a disturbance of consciousness. Whether the woman died in this situation due to the icy temperature as a result of hypothermia or whether she died or would have died solely due to benzodiazepine overdosage could not be clarified.

Adult↗
PubMed2002

[Determination of 7-aminoflunitrazepam, the major metabolite of flunitrazepam in urine by high performance thin-layer chromatography].

A rapid and highly sensitive method, based on high performance thin-layer chromatography, is described for the qualitative and semiquantitative determination of 7-aminoflunitrazepam, the main metabolite of flunitrazepam in human urine. 7-Aminoflunitrazepam in specimen was extracted by solid phase extraction using GDX-403 porous polymer bead as sorbent and ethyl ether as eluant. Fluorescamine was used as a reagent to produce fluorescent product on the plate. The limit of detection was 5 micrograms/L and the limit of quantitation was 15 micrograms/L for 7-aminoflunitrazepam in urine. The method can be successfully used for measuring 7-aminoflunitrazepam in urine samples of the subjects excreted over a 48 h period after receiving 1 mg flunitrazepam orally. The method is applicable to drug examination for the cases of drug-facilitated robbery and rape.

Chromatography, Thin Layer↗
PubMedDate not supplied

[Suicidal monointoxication with flunitrazepam. Further comment on coloration phenomena of the upper gastrointestinal tract].

Fatal monointoxications with benzodiazepines, for instance with a suicidal intention, are exceptional findings. We report the autopsy case of an 82-year-old woman who died due to a suicidal monointoxication with Rohypnol 1 mg film tablets (therapeutical agent: flunitrazepam). 0.065 mg/L flunitrazepam and 0.34 mg/L 7-aminoflunitrazepam were detected in a postmortem heart blood sample and toxicological analysis revealed the metabolite 7-aminoflunitrazepam in gastric contents, too. At external examination, a bluish-turquoise coloration was seen around the woman's right nostril and within the oral cavity. At autopsy, similar coloration phenomena were seen on the mucosa of the distal esophagus and the stomach. Formerly, bluish stains on mouth and nostrils were considered indicative of intoxications with organophosphates such as parathion (E 605). More recently, case reports accumulate where an intoxication with Rohypnol 1 film tablets (containing the coloring agent indigocarmine in its core) have to be considered as a potential differential diagnosis of such coloration phenomena.

Aged↗
PubMed1991

[Free fatty acids as an indicator of preoperative stress and effects of premedication with flunitrazepam, morphine and promethazine on blood fatty acid level].

We investigated the influence of different oral premedication given to 50 male and 50 female patients on the plasmaconcentration of free fatty acids (FFA) as an indicator of preoperative stress and compared them with patients given no premedication at all. FFA are measured with a gaschromatographic method. FFA were measured four times: Time 1 (t1): the first day in hospital, t2: After the anesthesiologist's visit, t3: In the morning of the operation, t4: Before starting anesthesia. The groups are: I. 20 male and 20 female patients without any premedication; II. every 10 patients of both sexes given 2 mg Flunitrazepam (p.o.) on the preoperative night; III. every 10 patients given Morphium (0.15 mg i.m.) and Promethazin (50 mg i.m.) and, last, IV. every 10 patients getting the same premedication as group II and IV. 98 patients had a significant decrease of FFA from t1 to t2. The FFA of all increased from t2 to t3. Moreover, there was an increase from t3 to t4. We conclude from this that no premedication we had investigated is able to lower the physiological and biochemical stress-response as far as shown by FFA. Apart from myristic-acid, there was no difference in the groups. However, with no statistic significance, both 'Flunitrazepam-groups' showed the lowest increase. Further, in 28 from 32 cases, females had a higher FFA-level than males (in 16 cases with statistical significance).

Adolescent↗
PubMed1977

[Cardiovascular effects of flunitrazepam (rohypnol, RO-5-4200) (author's transl)].

We reported on the haemodynamic effects of 0.03 mg/kg flunitrazepam during surgical procedures in neuroleptanalgesia in 39 patients with congenital or acquired heart diseases, functional class II-IV. The benzodiazepine derivative did not cause any relevant effect on the inotropic state of the myocardium. There were only minor changes in cardiac index, stroke index, right and left atrial pressure. Changes in arterial pressure and left ventricular pressure during and immediately after surgical procedures, and in arterial perfusion pressure during extracorporeal circulation, as well as an only short lasting increase in heart rate were demonstrative a peripheral vasodilator effect. The decrease in ventricular work and myocardial oxygen consumption are of value in patients with coronary heart disease, especially immediately after surgical procedures. Flunitrazepam is considered an additional drug during neuroleptanalgesia, when hypertension is causing some problems.

Adolescent↗
PubMed1990

Analysis of 526 cases of intravenous flunitrazepam sedation in dentistry.

Intravenous flunitrazepam sedation was evaluated in 526 dental out-patients. The sedative effect and amnesia to the local anesthetic injections was acceptable, as was the patients' evaluation of the method. Cardiorespiratory changes were minimal and venous complications extremely rare. Romberg's test performed 120 minutes after administration was normal in almost all cases. The patients' most common complaint after leaving the clinic was oral pain from the dental procedure. The results of this case series that intravenous flunitrazepam sedation is useful for dentistry.

Adult↗
PubMed1977

Anaesthetic induction and maintenance with flunitrazepam.

Flunitrazepam (Rohypnol) was investigated as an intravenous induction agent for dental procedures in 15 patients in a private anaesthetic practice. During this study it was noted that the normal halothane requirement could be reduced substantially. A second study to investigate this new phenomenon was done on 50 patients who underwent major surgery. The results indicate that adequate anaesthesia can be maintained with flunitrazepam.

Adolescent↗
PubMed1977

Bioavailability from various galenic formulations of flunitrazepam.

The absolute and relative bioavailability of flunitrazepam (Rohypnol) tablet, oral solution and suppository formulations was determined in a cross-over study on 6 healthy volunteers. The tablet and the oral solution were shown to be bioequivalent, absorption being at least 80%. For flunitrazepam suppositories the bioavailability was found to be about 50%. The plasma concentrations are described on the basis of a three-compartment model, the adjustment of the curves from the same subject being made simultaneously. The central compartment and the second compartment are about equal in size and rapid exchange takes place between them. The third compartment is about four times as large as the central one. The slow reflux of the compound from the third to the first compartment is the rate determining factor for the overall elimination in the beta-phase.

Adult↗
PubMed1989

[Comparative study of the antagonizing effect to flunitrazepam between Ro 15-1788 and physostigmine].

In a double blind, randomized, placebo-controlled study, thirty patients who had received flunitrazepam during operation were divided into three groups. At the end of surgery, one group was given a placebo, one group was given Ro 15-1788 (Benzodiazepine antagonist) and a third group was given physostigmine. Each group was assessed at the end of 5 minutes, 15 minutes, 30 minutes 60 minutes and 120 minutes for alertness/sedation, recall, recognition and motor coordination. At the end of 5 and 15 minutes, the patients who had received Ro 15-1788 showed a statistically significant difference in alertness/sedation from those in the other two groups (p less than 0.01). This group also showed a statistically significant difference in motor coordination at the end of 5 minutes (p less than 0.05). There was no significant difference in recognition or recall at anytime. Physostigmine showed no significant difference change from the control group at anytime in every aspect. In conclusion, Ro 15-1788 is an effective antagonist to the alertness/sedation of flunitrazepam, but physostigmine is not.

Adult↗
PubMed1989

[Clinical evaluation of the efficacy of Ro 15-1788, Anexate after balanced intravenous anesthesia with flunitrazepam and fentanyl].

Benzodiazepines are widely used as neuroleptics in anaesthesia, but they give rise to drowsiness at the end of surgery. Anexate is an imidazobenzodiazepine with specific antagonistic activity for benzodiazepines. We have administered 0.2 mg i.v. of the drug to 20 adult patients after anaesthesia with tiopentale (250 mg), pancuronium bromide (0.07 mg.kg-1), flunitrazepam (2 mg) and fentanyl (0.10 mg); after the first dose fentanyl was administered (0.10 mg) about every 30 minute. Analgesia was supplemented with nitrous oxide 66%. Blood pressure and heart rate did not changes significantly after Anexate; respiratory volume increased significantly in all cases (ANOVA P less than 0.001). Consciousness was rapidly resumed in all cases and patients demonstrated to be oriented in time and space soon after Anexate. In 14 out of 20 patients drowsiness reappeared after about 30 minute and further doses of 0.1 mg of the drug (to a maximum of 0.4 mg in some cases) were necessary. Side effects were rare and slight, their occurrence depending on the speed of administration. In our opinion a total dose of 0.3 to 0.4 mg Anexate is need to fully antagonize the sedative effect of 2 mg flunitrazepam.

Adult↗
PubMed1989

[Effectiveness of chlormezanone and flunitrazepam in treatment of difficult children].

Out of a total of 366 preschoolers, aged 3-5 years old, from the urban area of Curacautín, a sample of 46 children is selected using a behavioral classification to choose those children difficult to manage. A double-blind type investigation is realized using a posology of the drugs: Chlormezanone and Flunitrazepam as well as a placebo. The distribution of the doses is in accordance with the so called "Latin Table". The results obtained indicate that both drugs are effective, with a 90.6% success rate case of Chlormezanone and 92.8% effectiveness in the case of Flunitrazepam. In terms of the placebo, the success rate was 15% with a higher rate in the third medication, possibly due to better psychological predisposition on the child's part.

Child Behavior↗
PubMed1988

Effect of flunitrazepam (Rohypnol) on awareness during anaesthesia for caesarean section.

The incidence of awareness was compared in three groups of patients undergoing elective or emergency Caesarean section, using pethidine alone or pethidine plus flunitrazepam (Rohypnol), as adjuvants to nitrous oxide: oxygen, muscle relaxant technique of general anaesthesia. The use of 0.03 mg/kg body weight of flunitrazepam was associated with a low incidence (4%) of awareness, cardiovascular stability, postoperative sedation and anterograde amnesia. The reduced incidence of awareness is probably due to increased depth of anaesthesia and anterograde amnesic effect produced by the drug.

Adult↗
PubMed1985

A multi-centre, double-blind trial in general practice comparing the hypnotic efficacy and event profiles of flunitrazepam and temazepam.

Two hundred and ninety-nine patients requiring treatment for a sleep disturbance were recruited into a double-blind multi-centre trial by 47 doctors. Patients received either 1 mg flunitrazepam or 20 mg temazepam for from 7 to 14 days. Analysis of the results of assessment in 246 patients by doctors and patients indicated that flunitrazepam was significantly better than temazepam in the improvement of onset of sleep, reduction in nocturnal awakenings and early morning awakenings. The solicited event profiles of both treatments were similar and consistent with the low risk expected of a hypnotic.

Anti-Anxiety Agents↗