Faced with the increase in cases of abusive use of sleep medications, Anvisa has made it more difficult to prescribe zolpidem
You have probably experienced an episode of insomnia during your life – that difficulty falling asleep, staying asleep or going back to sleep after an unwanted awakening. And you’re not the only one: the Sleep Epidemiological Study (Episono), released in 2023, indicates that 45% of residents of the city of São Paulo suffer from insomnia. Faced with the inconvenience of not being able to sleep, it is not uncommon to hear reports of people resorting to psychotropic medications (such as zolpidem and zopiclone) without adequate medical supervision.
The indiscriminate use of these drugs and the risks of self-medication caught the attention of the medical community and Anvisa (National Health Surveillance Agency), which decided to make the prescription of these drugs more rigid., to curb abusive use.
These products are called “class Z drugs” (since the names start with that letter) and are recommended for patients with short-term insomnia, that is, when it has been going on for less than 90 days. They are hypnotics and sedatives that act specifically on the brain receptor called Gaba, which is the main inhibitory receptor in the central nervous system. They work like an “on and off” button, inducing sleep quickly — unlike benzodiazepines (such as clonazepam and nitrazepam), which also act against anxiety.
“The difference between one and the other is that the ‘Z drugs’ act only on the receptors that make us sleep, being widely used for insomnia, while benzodiazepines have broader actions”, explains neurologist Letícia Soster, from the Sleep Assistance Medical Group at Hospital Israelita Albert Einstein. And it is because of its quick effect – and the promise of waking up refreshed, without the feeling of a hangover – that irregular use is dangerous, especially for those who self-medicate.
According to Soster, as it is a medication with a rapid onset of action, it should only be used with a doctor’s prescription and immediately before bedtime, when the person is already lying down, to avoid the risk of inappropriate behavior. “The risk will increase if the person takes this medication and is not prepared to sleep. Some receptors will be turned off and, if she continues to be awake, using, for example, the computer, abnormal behaviors may occur, which she will not remember later.”says the neurologist, citing cases of abuse and even reports of people who purchased products or travel packages, argued with their partner and other similar situations.
There is also a risk of chemical dependency on the medication if it is used inappropriately and without supervision. According to Soster, the first sign is behavioral, when the patient begins to believe that they can only sleep if they take the medicine: “Z drugs have a very important chemical dependence mechanism because they act by blocking GABAergic receptors. The problem is that they work like a docking mechanism and, over time, this docking starts to work and only makes you fall asleep when the receiver is docked.”.
This means that, with continuous use and without adequate monitoring, the person begins to feel the need for a slightly higher dose of the medication., and increases it on its own, without the use of other essential strategies for treating insomnia. “People will increasingly need to increase doses and this is when indiscriminate and abusive use occurs, as we have seen. This is what motivated the entire movement to make access to medication more difficult.”says the expert.
According to neurologist Márcia Assis, vice-president of ABS (Brazilian Sleep Association), although Z medications are considered safe, it is necessary to be alert to cases of daytime drowsiness, especially in the elderly and women, who should use smaller doses.
The medication should also not be associated with the use of alcoholic beverages and other sedatives and hypnotics. “Dependence and withdrawal are undesirable effects observed in cases of abuse, alongside behavioral changes during sleep. It is important to remember, however, that risk situations occur in those who use doses beyond those recommended. Regular use, with medical supervision, is risk-free.”he states.
Prescription becomes stricter
Anvisa’s decision to make the prescription of zolpidem more rigorous also took into account the growth in consumption of the substance in recent years and the observation of an increase in the occurrence of adverse events related to it. Data from Sindusfarma (Pharmaceutical Products Industry Union) points to an increase of 15.9% in 4 years: 15.7 million units of medication were sold from May 2019 to April 2020 and 18.2 million from May 2023 to April 2024.
With the new resolution, the prescription of all medicines containing zolpidem or zopiclone, regardless of concentration, must be made using special prescription B, with a blue booklet, which is more controlled and can only be issued by professionals previously registered with local health surveillance – in general, specialists in psychiatry and neurology.
In addition, manufacturers must change the packaging, changing the stripe from red to black. Until then, despite the product already being part of the list of psychotropic and controlled substances, there was a loophole in the text that allowed prescription of up to 10 mg in two-part white prescriptions, by any doctor, without the need for prior registration. The new rules come into force on August 1st.
“We hope that the new regulations will help reduce indiscriminate use. ThisThe This measure also increases reflection and concern about the need for adequate treatment of insomnia. It is not done exclusively with the use of medication. Furthermore, when indicated, it must be prescribed by a specialized professional, who will evaluate the type of insomnia, possible causes, the factors that perpetuate the problem, associated diseases and other medical data.”, declares Assis, from ABS. The neurologist recalls that drug treatment for insomnia may even be a choice, but it should always be associated with non-pharmacological measures, such as reducing the use of screens and practicing physical activity.
Melatonin is also a concern
Another product that has been used indiscriminately and without medical supervision for the treatment of insomnia is melatonin, sold in pharmacies in the form of a food supplement (in tablets or drops). Popularly called the “sleep hormone”, melatonin is a hormone produced naturally by the body and is very important for regulating the circadian rhythm, that is, the cycle of wakefulness and sleep – our biological clock. As it is not considered a medicine, melatonin does not follow the same safety criteria required for a medication to reach the market.
Although Anvisa has limited the maximum amount of a melatonin dose unit to 0.21 mg, nothing prevents the patient from using much more. “There are reports of patients taking 10, 20, 30 melatonin tablets to sleep”says Soster, stating that there is little data on the long-term side effects of high dose and uncontrolled use. “As it is not a medicine, it is much more difficult to monitor and record adverse events”assesses Einstein’s doctor.
The experts’ recommendation when there are signs of insomnia is to see a doctor and carry out an evaluation – only a specialist will be able to say whether the use of any medication is necessary or not. There is no “magic number” for the minimum number of hours that should be slept, so the patient’s perception is essential. The first sign that sleep is not going well is noticing the damage to your routine during the day: they can be psychological and emotional, related to changes in mood, a lot of tachycardia, tiredness and drowsiness, among others.
“There are many symptoms that are related to a bad or little night’s sleep. They are quite broad and not very specific. The most valuable tip is to observe how you wake up: if you wake up tired, worried about sleep, or with a headache, when you should be more relaxed, this is a sign that your night’s sleep is not adequate.”explains Soster.
To get a refreshing night’s sleep, there’s no secret: you need to start the sleep hygiene process when you wake up. According to Soster, it is necessary to signal to the body that sleep is over, have contact with sunlight, perform physical activity to “tired” enough, maintain regular times for meals and other daily activities.
Close to bedtime, you need to show your brain that it’s time to switch off. Experts recommend:
- do not expose yourself to light half an hour before going to bed;
- maintain more relaxing activities;
- do not use the bed to work, study or watch television;
- reduce the use of screens and don’t take your worries to bed.
“If you can’t control your thoughts, a tip is to write them down in a notebook and go back to bed just feeling sleepy. This set of habits helps us to have a healthy sleep”says Soster.
With information from Einstein Agency.
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