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Does Aerinaze Cause Drowsiness? A Look at its Side Effects

3 min read

In clinical trials involving 414 adults, the most frequently reported adverse event for Aerinaze was insomnia (8.9%) [1.8.1]. So, does Aerinaze cause drowsiness? The answer is complex due to its combination of a next-generation antihistamine and a stimulant decongestant.

Quick Summary

Aerinaze combines a non-drowsy antihistamine (desloratadine) with a stimulant decongestant (pseudoephedrine). While drowsiness is a possible but very rare side effect for some, insomnia is more common.

Key Points

  • Dual-Action Formula: Aerinaze contains desloratadine (a non-drowsy antihistamine) and pseudoephedrine (a stimulant decongestant) [1.5.1].

  • Drowsiness is Uncommon: Official information states that very rarely some people experience drowsiness, but most do not [1.3.2].

  • Insomnia is More Common: In clinical trials, insomnia (difficulty sleeping) was reported in 8.9% of patients, making it a more frequent side effect than sleepiness [1.5.4].

  • Non-Sedating Antihistamine: The desloratadine component is a second-generation antihistamine, designed to not cross the blood-brain barrier and cause sedation [1.6.2, 1.9.3].

  • Stimulant Component: The pseudoephedrine in Aerinaze is a stimulant that can cause nervousness and trouble sleeping, counteracting potential drowsiness [1.2.4, 1.3.1].

  • Individual Variation: Patients are advised to see how the medication affects them before driving or using machinery due to individual variations in response [1.8.2].

  • Contraindications Exist: Aerinaze is not suitable for people with certain medical conditions like severe high blood pressure, glaucoma, or heart disease [1.8.1].

In This Article

Understanding Aerinaze and its Dual-Action Formula

Aerinaze is a prescription medication indicated for the symptomatic treatment of seasonal allergic rhinitis (hay fever) when accompanied by nasal congestion [1.5.3]. It is a modified-release tablet that contains a combination of two active ingredients: 2.5 mg of desloratadine and 120 mg of pseudoephedrine sulphate [1.5.1].

  • Desloratadine: This is a second-generation antihistamine [1.6.2]. Antihistamines work by blocking the effects of histamine, a substance the body produces during an allergic reaction that causes symptoms like sneezing, itching, runny nose, and watery eyes [1.2.1]. Second-generation antihistamines are designed to be non-sedating because they do not readily cross the blood-brain barrier [1.9.3].
  • Pseudoephedrine: This is a sympathomimetic agent that acts as a nasal decongestant [1.2.4]. It works by narrowing the blood vessels in the nasal passages, which helps to clear stuffiness [1.2.1]. However, as a stimulant, it can also cause central nervous system effects like increased heart rate, elevated blood pressure, and excitability [1.2.4].

This dual-action formula targets both the general allergy symptoms and the accompanying congestion simultaneously [1.2.4].

So, Does Aerinaze Cause Drowsiness?

The answer is generally no for most people, but it is not impossible. The European Medicines Agency (EMA) states that patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines [1.3.2]. However, it also notes that Aerinaze has no or negligible influence on the ability to drive and that most people do not experience drowsiness [1.8.2].

The pharmacology of its ingredients explains this. The antihistamine component, desloratadine, is specifically a non-drowsy type [1.6.2]. In clinical trials assessing driving ability, desloratadine alone caused no impairment [1.3.2]. The other ingredient, pseudoephedrine, is a stimulant. In clinical trials for Aerinaze, one of the most common side effects reported was actually insomnia (difficulty sleeping), affecting 8.9% of patients, far more than sleepiness [1.3.2, 1.5.4]. Other common side effects include dry mouth (7.2%) and headache (3.1%) [1.5.4].

While somnolence (sleepiness/drowsiness) is listed as a possible side effect, it is considered uncommon, affecting between 1 in 100 and 1 in 1,000 patients [1.3.1, 1.8.3]. The stimulant effect of pseudoephedrine often counteracts any potential sedative effect from the antihistamine. Therefore, while a small subset of the population might feel tired, a larger portion is more likely to experience restlessness or difficulty sleeping.

Comparison with Other Antihistamines

Not all antihistamines are created equal when it comes to drowsiness. The risk of sedation depends heavily on the generation of the drug.

Medication (Active Ingredient) Generation & Type Common Drowsiness Potential Notes
Benadryl (Diphenhydramine) First-Generation Antihistamine High Readily crosses the blood-brain barrier, causing significant sedation in 10-25% of users [1.9.1, 1.9.3].
Zyrtec (Cetirizine) Second-Generation Antihistamine Low to Moderate Considered non-drowsy, but is more likely to cause sedation than other second-gens. About 14% of users report drowsiness [1.6.3, 1.9.2].
Claritin (Loratadine) Second-Generation Antihistamine Low Generally non-sedating at recommended doses. Desloratadine (in Aerinaze) is its active metabolite [1.6.3, 1.8.1].
Allegra (Fexofenadine) Second-Generation Antihistamine Very Low Considered the least sedating of the newer antihistamines as it doesn't cross the blood-brain barrier well [1.6.3, 1.6.4].
Aerinaze (Desloratadine/Pseudoephedrine) Second-Gen Antihistamine + Decongestant Very Low / Uncommon The desloratadine component is non-drowsy, and the pseudoephedrine is a stimulant that can cause insomnia [1.3.2, 1.6.2].

Managing Potential Side Effects and Precautions

While drowsiness is uncommon, other side effects like insomnia, dry mouth, or dizziness may occur [1.3.1].

  • Know Your Reaction: Because there is individual variation in response to any medication, it's advised not to drive or operate heavy machinery until you have established how Aerinaze affects you personally [1.8.2].
  • Managing Dry Mouth: For dry mouth, using sugarless candy or gum, melting ice chips in your mouth, or using a saliva substitute can provide temporary relief [1.7.4].
  • Avoid Alcohol: Drinking alcohol with this medicine can increase side effects like dizziness [1.8.5].
  • Contraindications: Aerinaze should not be used by individuals with certain conditions, including narrow-angle glaucoma, urinary retention, severe high blood pressure, certain cardiovascular diseases, or an overactive thyroid. It is also contraindicated for those taking MAO inhibitor antidepressants [1.8.1, 1.8.3].

Conclusion

For the majority of users, Aerinaze is unlikely to cause drowsiness. Its formulation combines a non-sedating second-generation antihistamine, desloratadine, with a stimulant decongestant, pseudoephedrine. Clinical data supports this, showing that insomnia is a much more frequently reported side effect than sleepiness [1.3.2]. However, as with any medication, individual responses can vary. A very small number of people may experience drowsiness [1.3.2]. It is crucial to be aware of how the medication affects you before engaging in activities that require full mental alertness and to consult a doctor about any concerning side effects or pre-existing conditions.


For more detailed information, consult the official patient information leaflet from the European Medicines Agency. Aerinaze Product Information - European Medicines Agency

Frequently Asked Questions

Aerinaze tablets contain two active ingredients: 2.5 mg of desloratadine (an antihistamine) and 120 mg of pseudoephedrine sulphate (a decongestant) [1.5.1].

No, drowsiness (somnolence) is not a common side effect. It is listed as affecting between 1 in 100 and 1 in 1,000 patients. Insomnia (difficulty sleeping) is reported much more frequently [1.3.1, 1.5.4].

Aerinaze is considered to have no or negligible influence on the ability to drive for most people. However, because a very small number of individuals might experience drowsiness, it is recommended to know how the medicine affects you before driving [1.8.2].

In clinical trials, the most frequently reported adverse events were insomnia (8.9%), dry mouth (7.2%), and headache (3.1%) [1.5.4].

Aerinaze contains both an antihistamine (desloratadine) and a decongestant (pseudoephedrine) to treat both allergy symptoms and nasal congestion [1.2.4]. Regular Claritin contains only the antihistamine loratadine, which is the parent drug of desloratadine [1.4.6].

Insomnia is the most common side effect of Aerinaze, reported by 8.9% of users in clinical trials [1.5.4]. If you already have trouble sleeping, you should discuss this with your doctor, as the pseudoephedrine component may worsen it.

It is advised to avoid drinking alcohol while taking this medicine as it can increase side effects such as dizziness [1.8.5].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.