Cuzco Health Center (Fuenlabrada)
According to the Royal Spanish Language Academy, anxiety1 has two definitions:1. f. A state of agitation, uneasiness or apprehension. 2. f. Med. The distress that tends to accompany many diseases, especially certain neuroses, giving its sufferers no relief. Insomnia¹ has a single definition: 1. m. Wakefulness, inability to fall asleep or remain asleep.
Although these definitions are not medical, they demonstrate that anxiety and insomnia are not always pathological. Anxiety is a normal, useful and common reaction when we are faced with compromising situations, and not just on a mental level, as it increases our state of alertness and activates our defense mechanisms. Insomnia refers to difficulty in getting to sleep or remaining asleep, waking early or frequently during the night, and it, too, is not always pathological and does not always need treatment. The prevalence of insomnia is around 20%, increases with age and is more common in women (23.9%) than men (17.6%). Insomnia is associated with depressive or anxiety disorders in 90% of cases.
Benzodiazepines were introduced in the pharmaceutical market in Spain in the 1960s, since when their use has grown constantly due to their anxiolytic, hypnotic and sedative properties and their broad safety margin. In 1987, 27 years ago, more than 18 million packages containing benzodiazepines as the main ingredient were taken in Spain2. It is worth considering that in 1987, according to the census, Spain had a population of some 38 million inhabitants.
The classification of drugs used for anxiety and insomnia falls under the therapeutic group “NO5B Anxiolytics, sedatives and hypnotics”3, in which there are a large number of commercial brands which are divided into the following subgroups:
- NO5B1A: Benzodiazepines with intermediate/long-term action. This group includes Bromazepam (Lexatin®), Clobazam (Noiafren®), Clorazepate Dipotassium (Tranxilium®), Chlordiazepoxide (Huberplex®), Diazepam (Valium®), Flurazepam (Dormodor®), Flunitracepam (Rohipnol®), Halazepam (Alapryl®), Ketazolam (Sedotime®), Pinazepam (Duna®) and Quazepam (Quiedorm®).
- NO5B1B: Benzodiazepines with short-term/intermediate action. This group includes Alprazolam (Trankimazin®), Bentazepam (Tiadipona®), Brotizolam (Sintonal®), Clotiazepam (Distensan®), Loprazolam (Somnovit®), Lorazepam (Orfidal®), Lormetazepam (Noctamid® and Loramet®), Midazolam (Dormicum®) and Triazolam (Halcion®).
- NO5B1C: Other anxiolytics and hypnotics that are not simply barbiturates. These are drugs from a varied group which cannot be classified elsewhere, are very heterogeneous and even include antihistamines. This group includes Buspirone (Buspar®), Clomethiazole (Distraneurine®), Doxylamine (Dormidina®), Zaleplon (Sonata®), Zolpidem (Stilnox®) and Zopiclone (Limovan®).
- NO5B2A: Anxiolytic or hypnotic in association. Aneurol® and Vincosedan®.
- NO5B3: Barbiturates. These are no longer used for treating anxiety or insomnia as they have been sidelined for use in anesthesia and epilepsy.
- NO5B4: Sedative plants: Lemon balm, passionflower, valerian.
This complex classification system, which doctors are familiar with, is not in this article for a review of pharmacology. It is here for the purposes of a simple exercise: to go to your first-aid cabinet at home and check the drugs that are taken by you, your parents, your grandparents or your siblings. You will find that although they drive on a regular basis, they also take these drugs on a regular basis, and in many cases, especially in the case of sedative plants, in association with other drugs that also induce drowsiness. For all these drugs, the prospectus states that they can cause drowsiness, confusion, changes in color perception, depression of the central nervous system, etc. and among the precautions to be taken are to avoid the use of dangerous machinery and motor vehicles. Moreover, the use of these drugs should be limited to a 2-4 week period for insomnia and no more than 3 months for anxiety, unless specifically prescribed otherwise, and yet in our surgeries we come across large numbers of patients who have been taking them continuously for several years.
If we add to the regular side effects of anxiolytics and hypnotics the actual symptoms that are caused by anxiety and insomnia (which, in the absence of restorative night sleep, causes daytime symptoms), such as mood swings, daytime fatigue, irritability, lack of attention and concentration, lack of energy, academic or occupational decline, slower reflexes and headaches, this even further enhances the risk of traffic accidents.
These data refer to therapeutic use , as their use as recreational drugs, often associated with the consumption of alcohol and other drugs, even further worsens the state of the person taking them in terms of driving and road safety, including pedestrians, and this is regulated in the Criminal Code.
To give you an idea of the scale of this problem, the 2012 Report on Traffic Accident Casualties, analyzed by the National Institute of Toxicology and Forensic Sciences (INTCF), reporting to the Ministry of Justice, obtained the following information4:
- Total deaths analyzed 832: 615 drivers, 53 passengers and 164 pedestrians.
- 291 of the dirives killed (47.32%) showed positive blood results for drugs and/or psychotropic drugs and/or alcohol (negative result <= 0.3 gr/L).
- Of the 48 victims who showed positive for psychotropic drugs, benzodiazepines were present in 38 of them.
- Of the12 victims who had mixed alcohol and psychotropic drugs, all of them showed positive for benzodiazepines and one of them also showed a hypnotic.
- Of the 20 drivers killed who showed positive for psychotropic drugs+alcohol, psychotropic drugs+recreational drugs, or psychotropic drugs+recreational drugs+alcohol, benzodiazepines appeared in 16 of them.
- Of the 164 pedestrians killed, 84 (51.22%) showed positive for drugs and/or psychotropic drugs and/or alcohol. Of these, 45 showed positive for psychotropic drugs of which 36 showed positive for benzodiazepines and one for a hypnotic.
If these cold data make chilling reading, then even more so is the fact that in the last five years, according to the comparative study carried out by the INTCF between 2008 and 2012 in the same 2012 Report, positive results for psychotropic drugs in deceased drivers had increased from 6.97% to 13.49%, and in pedestrians from 11.2% to 27.43%.
Also, in its report entitled “The use of anxiolytic and hypnotic medication in Spain between 2000 and 2012” 5 published in January this year, the Ministry of Health, Social Services and Equality reflected the increase in the consumption of these drugs, which has grown by 57.4%. The anxiolytic group rose by 46.8% and the hypnotics/sedatives group by 81.8%.
The Official State Gazette no. 85 of 8 April 2014 published the amendment to the Law on Traffic, Circulation of Motor Vehicles and Road Safety passed by Royal Legislative Decree 339/1990 of 2 March 1990. In it, Preamble VI states textually “article 12 substantially modifies the regulation on the presence of drugs in driving. From an administrative point of view, the simple presence of drugs in the driver’s body shall be punished, which exclude those substances used under a doctor’s prescription for therapeutic reasons, PROVIDED THAT THE DRIVER IS IN A CONDITION TO USE THE VEHICLE IN ACCORDANCE WITH THE OBLIGATION TO OBSERVE DILIGENCE, CARE AND NO DISTRACTIONS established in article 9, leaving for the criminal offense envisaged in article 379.2 of the Criminal Code for driving under the influence of drugs.”
With the recent amendment of the Road Safety Act and the toughening-up of penalties, more and more patients are asking for information about the possibility of “showing positive” to these substances. The important thing is not whether they are “showing positive or negative” but that they are driving safely. Benzodiazepines can be determined from samples of saliva, urine and blood. Blood and urine samples are taken in medical centers for the purposes of diagnoses and treatment control, although blood samples can also be requested after taking saliva samples by the Civil Guard or Police in order to quantify the drug. These blood samples generally take place after there has been a positive saliva test and the person concerned has been involved in an accident, or is showing signs of intoxication, or refuses to take the saliva test to quantify the dose taken. The samples are taken in accordance with the established protocol and require the sample to be safeguarded from the moment of extraction through to its arrival in the toxicology lab for determination.
To sum up, benzodiazepines are widely-used drugs whose use is becoming more prevalent and are present in the bodies of a large percentage of people who have died in traffic accidents, whether drivers, passengers or pedestrians. They are often taken in association with other drugs and alcohol or with sedative plants, often without the doctor’s knowledge, and are used for much longer periods than prescribed or recommended. This is not counting the presence of other medications which might induce drowsiness (antihistamines, some analgesics, antidepressants, anti-migraine medication, etc.) and processes which might also induce sleepiness (obstructive sleep apnea, migraine, irregular sleep patterns, shift work, etc.).
The existence of a doctor’s prescription does not absolve the person from responsibility; the prescription must be accredited and the person must also be in a fit state to drive. Thus the presence of signs of intoxication, even if there is a prescription, can lead to the immobilization of the vehicle and the consequent fine plus, as determined by the new Law, the removal of 6 points from the driver’s license. Intoxication can cause depression of the central nervous system, with ataxia, lethargy, drowsiness and confused speech, mydriasis, nystagmus and divergence paralysis, and at a cardiovascular level it can cause bradycardia, tachycardia and low blood pressure.
Road safety advice
- Use benzodiazepines at the lowest possible dose to achieve the desired effect and for the shortest possible time, reducing them progressively until finally stopping them. If you think the anxiety or insomnia is going to last for some time, assess the use instead of antidepressants (especially selective serotonin-uptake inhibitors) to try to withdraw the benzodiazepines. On long journeys, make frequent stops and always try to travel with someone else. Avoid intense heat in the vehicle.
- Avoid the use of other drugs which might induce drowsiness or enhance the depressive effect on the central nervous system of benzodiazepines. Naturally, alcohol is completely out of the question. Alcohol, benzodiazepines and driving is a very bad combination.
- Take a great deal of care with treatments from health food shops, homeopathic medicines or natural plant cures which can induce drowsiness. Patients often do not regard these substances as drugs, and doctors are not aware that they are using them. Do not use them before driving.
- In medical tests conducted under sedation (when Midazolam is usually used), make sure someone goes with you and do not drive on the day of the sedation.
- Pedestrians also need to take greater care to avoid accidents. Only cross on zebra crossings or traffic lights and look both ways. Never think “I’ve got plenty of time” as your reaction capacity may be diminished.
- Dictionary of the Royal Spanish Language Academy.
- Acute intoxication from benzodiazepines. Instructions for treatment with Flumacenil. S Nogué et al. Revista Emergencias SEMES.Vol 1, Nº 6, 1989.
- Medimecum 2013. Guide to Pharmacological Treatment
- 2012 Report on Traffic Accident Casualties, National Institute of Toxicology and Forensic Sciences. 19 March 2013.
- Use of anxiolytic and hypnotic drugs in Spain between 2000 and 2012. Spanish Agency for Medicines and Medical Devices, Ministry of Health, Social Services and Equality. 27 January 2014.
- Official State Gazette No. 85, of 8 April 2014.