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Anvisa restricts rules for prescribing and selling Zolpidem; see what changes

Anvisa (National Health Surveillance Agency) approved, on Wednesday (15), a increased control for the drug Zolpidem , for the treatment of insomnia. With the change, any medication containing the substance must be prescribed through Prescription Notification B (blue), as the product is part of the list of psychotropic substances in the controlled substances standard in Brazil.

This type of prescription requires that the professional who prescribes the medicine is previously registered with the local health surveillance authority. According to Anvisa, the decision was taken following the increase in reports of irregular and abusive use of Zolpidem.

“The analysis conducted by Anvisa demonstrated an increase in the consumption of this substance and an increase in the occurrence of adverse events related to its use. It was also possible to identify that there is no scientific data that demonstrates that concentrations of up to 10 mg of the medicine deserve a different regulatory criterion”, says a statement released by the agency.

What changes with the new rules?

Zolpidem was already included in list B1 (psychotropics), which is more restricted, however, according to Anvisa, addendum 4 of that same list relaxed the restriction and provided that medications with up to 10 mg of Zolpidem per dosage unit would be equivalent to medications in “List C1 – List of Substances Subject to Special Control”.

This category allows the prescription to be written in two copies of a white prescription and there is no requirement for the professional who prescribes to be previously registered with the local health authority.

With the exclusion of Addendum 4 of List B1 of Ordinance 344/1998, from August 1st of this year, Revenue Notification B (blue) becomes mandatory for the prescription and dispensing of all Zolpidem-based medications regardless of the concentration of the substance.

The deadline was set for prevent patients from having any discontinuity in treatment . Therefore, until August 1st, these people will be able to continue purchasing the medicine with their previous prescription until they obtain the appropriate prescription.

Furthermore, the agency says that this is the time necessary for professionals who are not yet registered to prescribe in the Blue Revenue Notification to register with the local health authorities to receive numbers to create their prescription books.

Medicines, including those with packaging with a red stripe, may be dispensed in pharmacies until the end of their expiration date, upon presentation of Prescription Notification B, in blue.

In relation to companies that manufacture medicines with Zolpidem, the adequacy of leaflets and labeling must occur in the manner already established in Anvisa regulations.

Until December 1, 2024, manufacturers of these medicines will be able to manufacture them with packaging with a red stripe. After this date, all medicines manufactured based on Zolpidem must already contain a black stripe on their packaging, as required for medicines on List B1 of Ordinance SVS/MS 344/1998.

What is Zolpidem and what are the risks of irregular use

Zolpidem is a medicine from the hypnotic family, which acts on the body to induce sleep and should only be used for a short period of time — according to Anvisa, its use should not exceed four weeks. Therefore, it is indicated for the treatment of transient or occasional insomnia.

“Treatment beyond the maximum period should not be extended without a reevaluation of the patient's condition, as the risk of abuse and dependence increases with the dose and duration of treatment,” the agency says.

Sales of the drug grew in Brazil, especially during and after the Covid-19 pandemic. In 2018, Anvisa estimates that 13.1 million boxes of Zolpidem were sold in Brazil. In 2022, the estimate soared to 21.9 million boxes, a 67% increase in sales.

“There has been a significant increase in the number of users in the last year, and more significant in Brazil compared to the rest of the world. We can say that consumption increased almost in a geometric progression. [Os médicos] began to prescribe it due to the false sense of security, that it would not generate dependence or abuse”, says Dalva Poyares, researcher at the Sleep Institute, in an article previously published in CNN .

According to the researcher, not only did access to the medicine increase after the wave of prescriptions, but also, mainly, “unmonitored prescription” increased, facilitating the occurrence of side effects such as sleepwalking, memory blackouts, hallucinations, among others .

*With information from Fernanda Pinotti

Source: CNN Brasil

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