Medicine for treating insomnia is being consumed irregularly and there is abuse, says agency
The board of Anvisa (National Health Surveillance Agency) unanimously approved on Wednesday (May 15, 2024) an increase in control over the prescription of the drug zolpidem, indicated for the treatment of insomnia.
From now on, medicines that have zolpidem in its formulation will have to be prescribed through prescription notification B, the blue prescription, which requires that the doctor issuing it be previously registered with the local health surveillance authority.
According to the agency, the product is part of the list of psychotropic substances and, therefore, must follow the prescription standards adopted for controlled medicines.
Zolpidem was already on the B1 list of psychotropic drugs, which is already restrictive. However, an addendum to the standard relaxed the restriction and provided that medications with up to 10 mg of zolpidem per dosage unit were prescribed in a two-part white prescription and there is no requirement for the prescribing professional to be previously registered..
“The measure was adopted from the increase in reports of irregular and abusive use related to the use of zolpidem”, explained Anvisa in note. The agency said it detected “an increase in the consumption of this substance and the observation of an increase in the occurrence of adverse events related to its use”.
Also according to Anvisa, “there is no scientific data that demonstrates that concentrations of up to 10 mg of the drug deserve a different regulatory criterion”.
What is zolpidem
Zolpidem is a hypnotic agent indicated for the short-term treatment of insomnia, when the patient has difficulty falling asleep and/or staying asleep. Its use is not recommended for more than 4 weeks, as is the use of all hypnotics.
“Treatment beyond the maximum period should not be extended without a reassessment of the patient’s condition, as the risk of abuse and dependence increases with the dose and duration of treatment.”, explained Anvisa.
What changes with the standard
From August 1, 2024The revenue notification B (blue) becomes mandatory for the prescription and dispensation of all zolpidem-based medications, regardless of the concentration of the substance.
The deadline was defined to prevent patients from having their treatment interrupted. It is also necessary for doctors who do not have a registration to prescribe medication with a blue prescription to do so at the local health authorities.
Manufacturing companies
Pharmaceutical companies will have to change the leaflet and labeling of medicines. Boxes with a red stripe may be manufactured atuntil December 1, 2024. After this date, all medicines will need to leave the factory with a black label on the packaging.
In the pharmacies, medicines with a red stripe They may be sold until the end of the expiration date, upon presentation of a blue receipt.
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