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Anvisa restricts prescription of zolpidem and zopiclone in insomnia treatments
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The board of the National Health Surveillance Agency (Anvisa) approved this Wednesday (15), a resolution that tightens the prescription of the drugs zolpidem and zopiclone, commonly used for the specific treatment of cases of insomnia. Medications can only be indicated if they have a blue prescription, which has stricter control. The measure will come into effect from August 1, 2024.

Previously, health legislation allowed concentrations of up to 10 mg of zolpidem and zopiclone to be prescribed in white prescriptions, in which one copy remains with the patient and the other with the pharmacy. This practice caused irregular consumption of the medicine to increase. With the new resolution, pharmacists will require blue prescriptions to release the medicine. This will make monitoring the prescription and proper use of medicines easier.

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Resolution changes

In blue type medical prescriptions, the details of the person responsible for indicating the medication are duly indicated. This type of prescription also requires the professional to be registered with the health authority of the place where they practice their profession. With this control, doctors will be limited to a specific number of prescriptions of this nature.

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Example of a blue recipe (Photo: reproduction/Insert Guide)


Furthermore, it is only possible to prescribe a medicine in blue type prescriptions, which contains a quantity proportional to a 30-day treatment, the same expiration date as the prescription. All zolpidem-based medicines can be manufactured until December 1st with a red label. After this date, the black stripe must appear on the medicines.

The dispensing of medicines in pharmacies can be carried out normally, regardless of the label, as long as it is within the expiry date and with the presentation of the blue prescription.

What is zolpidem

Zolpidem is a medicine used to induce sleep and is generally used to treat insomnia, and it must be purchased with a prescription. The medicine has a side effect of sedation, which can lead to sleepwalking. The drug leaflet itself makes this warning, highlighting that the person may not remember what they did while sedated.

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Psychiatrist Amilton dos Santos Júnior explains the need to take the medicine and not get out of bed to carry out other activities. “Some people are sensitive, there are people who take it and go to the bakery and this is dangerous, because the medicine can have an effect. If the person is driving, they can crash the car. The patient can also do something and regret it later, they can talk in their sleep, walk in their sleep”adds the specialist.

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Zolpidem dependence

Zolpidem is a medication that can cause dependence, depending on the increase in the dose taken and the length of treatment. Taking the medicine should not exceed a period of 4 weeks, as indicated in the leaflet. For psychiatrist, Amilton dos Santos, the use of zolpidem should not be the first option in the treatment of insomnia.

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He recommends that the patient try to make changes in their habits and start treatment with non-pharmacological measures. These measures involve sleep hygiene, avoiding products with caffeine and using screens before bed.

Featured photo: Anvisa restricts prescription of zolpidem and zopiclone in insomnia treatments (Reproduction/Tom Merton/Getty Images Embed)

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