Popular Sleep Aid, DroomSap, Linked to Concerning Side Effects & Raises Safety Questions
The Netherlands – Health authorities are warning consumers to discontinue use of the sleep aid DroomSap following a surge in reported adverse reactions, including cases in young children. Dozens of individuals have sought guidance from the National Poisons information Center (NVIC) at UMC Utrecht hospital after experiencing negative effects linked to the product.
DroomSap is marketed as a natural remedy for sleep difficulties, highlighting ingredients like herbs and honey. However, its primary active component is doxylamine, a chemical substance whose sale without a prescription is illegal in the Netherlands.
Reports submitted to Lareb, the Netherlands Center for Adverse Drug Reactions, detail a range of concerning side effects.These include potentially serious issues like epileptic attacks, difficulty concentrating, vivid nightmares, and increased pressure within the eyeball. Other reported symptoms are varied and include palpitations, hallucinations, restless legs, severe itching, dizziness, diarrhea, erectile dysfunction, tingling sensations, and double vision.
Crucially, Lareb notes that the majority of these problems resolved after users stopped taking DroomSap.
The NVIC has received over thirty complaints,with reports detailing loss of consciousness,fainting spells,anxiety,chest pain,and diarrhea. Alarmingly, four of those affected were under the age of 10, and three were teenagers. The NVIC also received inquiries from a police officer and a general practitioner assistant, both reporting that colleagues working night shifts were using the product. Based on the reports received, the NVIC has issued a strong advice against further use of DroomSap.
A regulatory loophole currently allows DroomSap to be sold as a food product rather than a medicine, due to the relatively low dosage of doxylamine it contains. This classification bypasses the prescription requirement that would apply if it were categorized as a pharmaceutical. Lareb has now alerted the Dutch Food and Consumer Product Safety Authority (NVWA) to the reported side effects, prompting a potential review of the product’s status and safety.