Modafinil is a pregnancy category C drug as classified by the US Food and Drug Administration (FDA). It is also categorized as B3 pregnancy medicine by the Australian Therapeutic Goods Administration (TGA).
Healthcare providers do not recommend Modafinil during pregnancy and breastfeeding. They encourage exploring alternative treatments as Modafinil may pose risks to the developing fetus and nursing infant.
Modafinil is a stimulant known for its wakefulness-promoting effects and cognitive benefits. This Nootropic is commonly prescribed to treat conditions of extreme daytime sleepiness due to narcolepsy, sleep apnea, and shift work sleep disorder. However, Modafinil use during pregnancy and breastfeeding raises essential questions and considerations due to potential risks to both the mother and the developing child.
Medications can impact maternal health and fetal development during pregnancy and breastfeeding. It's crucial for pregnant and breastfeeding mothers to be well-informed of the safety and potential risks associated with medications such as Modafinil.
This blog explores expert insights on using Modafinil during pregnancy and breastfeeding, including its risks when taken with birth control. We will also explore safety, expert advice, research, and alternatives for conditions treated with Modafinil during these phases. Let us understand Modafinil's impact on maternal and infant health under the guidance of obstetrics, gynecology, and pharmacology specialists.
Modafinil Pregnancy Category
In the United States, the FDA categorizes Modafinil as Pregnancy Category C [1]. It indicates that animal studies have shown adverse effects on the fetus, but there are limited studies on humans.
The Therapeutic Goods Administration (TGA) classifies Modafinil as Pregnancy Category B3 in Australia. This category indicates that animal studies show potential fetal harm, but its relevance in humans is uncertain.
The US and AU classifications highlight the need for caution and careful consideration when using Modafinil during pregnancy.
Modafinil Use During Pregnancy
The Medicines and Healthcare Products Regulatory Agency (MHRA) advises reviewing the risks of using Modafinil during pregnancy before its administration. The effects of taking Modafinil during pregnancy are listed below.
An Interim Report By Modafinil Manufacturer-
In 2018, Teva Pharmaceutical, the manufacturer of Modafinil, reported from Pregnancy Registries that 15% of infants had malfunctions associated with Modafinil exposure [14].
Safety Concerns and Potential Risks-
The potential risks associated with Modafinil use during pregnancy include:
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Increased risk of miscarriage or stillbirth.
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Potential birth defects or developmental abnormalities.
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Effects on fetal growth and development.
Studies and Research Findings-
Research on Modafinil's effects on pregnancy outcomes is limited but evolving. Some studies suggest adverse outcomes, while others may not show significant concerns. A few studies discussing the risks of Modafinil during pregnancy are provided here-
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A study by Per Damkier et al. indicates the use of Modafinil during pregnancy may increase the likelihood of congenital malformations. Congenital malformations are birth defects that occur when a baby is born with a physical abnormality or structural problem.
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Based on the same study, the other side effects resulting from Modafinil, if taken during Pregnancy, are hospitalization due to malfunction, diabetes, hypertension, mood disorder, and other mental and behavioral disorders [13].
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A study by Sigal Kaplan et al. showed a higher risk of birth abnormalities when exposure to Modafinil occurred in the first trimester.
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The fetus is also diagnosed with multiple sclerosis (27%) and sleep disorder (39%), according to a study evaluating the risk of Modafinil during pregnancy in 49 women [13].
Expert Recommendations And Guidelines
Healthcare professionals generally do not advise using Modafinil during pregnancy unless the benefits outweigh the potential risks.
Alternative treatments are often recommended to manage conditions like narcolepsy or sleep disorders during pregnancy. A few natural therapies are-
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Maintain sleep hygiene, such as maintaining a regular sleep schedule, creating a comfortable sleep environment, and avoiding stimulants before bedtime.
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Relaxation exercises, such as deep breathing, yoga, or meditation, can promote better sleep and reduce stress.
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A balanced diet and regular exercise can improve overall well-being and sleep quality.
Modafinil Use During Breastfeeding
Breastfeeding mothers must consider medication use carefully due to the potential transmission of substances like Modafinil through breast milk. Here are the key aspects of Modafinil use during breastfeeding:
Transmission Of Modafinil Through Breast Milk-
Modafinil is known to pass into breast milk, exposing the nursing infant to the medication. According to a study by Sanjay Aurora et al., Modafinil's relative infant dose (RID) is 5.3%. RID is how much of a drug a baby gets through breast milk compared to how much the mother takes, based on their body weight.
Also, due to its mechanism of action on the central nervous system and various neurotransmitter receptors, the Nootropic may pass via the blood-brain barrier to the newborn [17].
The concentration of Modafinil in breast milk can vary based on factors such as maternal dosage and metabolism.
Potential Impact On The Infant
According to clinical reports, there are no severe concerns about the infant’s health. However, it is crucial to monitor the infants for any symptoms such as
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Insomnia
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Jitteriness
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Poor weight gain
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Anorexia.
If any of these events occur, it is recommended that the mother either discontinue breastfeeding or avoid the Nootropic [17].
Expert Advice On Modafinil For Breastfeeding Mothers
It's essential for breastfeeding mothers to discuss with their healthcare providers to weigh the benefits and risks carefully. Until additional safety data is accessible, it's advisable to avoid using Modafinil and consider using an alternative medication.
Modafinil And Birth Control
Women on birth control might experience mood swings or depression, and studies show they're more likely to use antidepressants [1,2]. Modafinil improves signs of depression and is often used by those who don't respond to their prescribed depression medication [3]. However, many women combine Modafinil with birth control without knowing the risks.
Modafinil And Birth Control Interaction
Modafinil or its brand drugs, such as Modalert, are enzyme inducers that increase the liver enzyme's action. These enzymes play a crucial role in breaking down contraceptives, thus giving them less time to act than intended [4]. This lowers the effectiveness of the contraceptive, thus elevating the possibility of pregnancy.
Author Note-
The information in this blog has been verified as true and cross-checked by specialists in obstetrics, gynecology, and pharmacology-
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Dr. Vijay Singh, Obstetrics & Gynecology.
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Dr. Udai Kumar Bisen, General Medicine.