Provigil and Nuvigil
Side Effects, Birth Defects, and Injuries

Provigil and Nuvigil, two popular sleep-disorder medications, have numerous side effects. Some of the most severe and consequential effects include Provigil and Nuvigil birth defects.

Provigil and Nuvigil Birth Defects

Teva Pharmaceuticals is the manufacturer of Provigil and Nuvigil. These two drugs are brand-name sleep-disorder drugs derived from the generic drugs modafinil (Provigil) and armodafinil (Nuvigil). These drugs are used to treat sleep disorders, such as sleep apnea, narcolepsy and shift-work disorder.

In 2019, Teva Pharmaceuticals informed European health care providers that research revealed congenital disorders — which are conditions present at or before birth — associated with modafinil and armodafinil. This revelation was based on the 2018 results of the still-ongoing Nuvigil/Provigil Pregnancy Registry.

Provigil and Nuvigil are most dangerous during the first and second trimesters, when the fetus’ organs are still forming. These birth defects can also occur for women who take the drug within six weeks prior to conception.

In the letter, the company listed four Provigil and Nuvigil birth defects linked to pregnant women using these sleep-disorder medications:

Congenital heart defects

Orofacial clefts (cleft lip or cleft palate)

Hypospadias

Microcephaly

Provigil and Nuvigil Congenital Heart Defects

According to the Centers for Disease Control and Prevention (CDC), congenital heart defects are the most common type of birth defect. They can affect the structure of the child’s heart, restrict blood flow and may require surgery. Provigil and Nuvigil congenital heart defects can be serious and even life-threatening.

According to the CDC, some of the symptoms of congenital heart defects are:

Blue-tinted nails or lips

Irregular breathing, such as fast or slow

Fatigue during feeding

Some of the most common congenital heart defects are:

Atrial Septal Defect — A hole in the wall, also called the septum, between the upper chambers of the heart

Coarctation of the aorta — Part of the aorta, which is the tube that carries oxygen-filled blood to the rest of the body, is narrower than usual

Hypoplastic left heart syndrome — The left side of the heart does not form correctly

Pulmonary atresia — A defect of the pulmonary valve, which carries blood from the heart to the lungs

Total anomalous pulmonary venous return — An inability for the lungs to deliver oxygen-rich blood to the left side of the heart, which means it instead goes to the right chamber and mixes with oxygen-poor blood and affects healthy blood flow to the rest of the body

Tricuspid atresia — A defect of the tricuspid valve, which carries blood from the heart’s upper-right chamber to the lower-right chamber and is needed to deliver blood to the lungs

Truncus arteriosus — A lack of separation between the aorta and the main pulmonary artery, the two main blood vessels coming out of the heart

Ventricular septal defect — A hole in septum between the heart’s lower chambers

Provigil and Nuvigil Orofacial Clefts

Orofacial clefts are more commonly known as cleft lip and cleft palate. Both can form due to pregnant women or soon-to-be-pregnant women taking Provigil or Nuvigil. These birth defects may require multiple surgeries.

Cleft Lip

According to the CDC, cleft lip usually forms between the fourth and seventh weeks of pregnancy. This condition occurs if the tissue that comprises the lip does not fully form during pregnancy. Cleft lip is characterized by an opening in the upper lip. The opening could be small, or it could be large enough to reach the nostril.

Cleft Palate

Cleft palate usually occurs during the sixth and ninth weeks of pregnancy, when the mouth’s roof fully forms. Cleft palate occurs when the roof of the mouth’s tissue does not fully form, leaving an irregularly shaped top of the baby’s mouth. The disorder ranges in severity based on how much of the tissue formed.

Provigil and Nuvigil Hypospadias

Hypospadias is a birth defect that only affects male babies. It is characterized by the opening of the penis being on the underside rather than at the tip. This opening is called the urethra, which is the tube that the body uses to drain urine from the bladder. Hypospadias can make urination difficult.

Provigil and Nuvigil hypospadias cases have occurred. This birth defect may require multiple surgeries.

Provigil and Nuvigil Microcephaly

Microcephaly is a birth defect where the circumference of the head is smaller than expected. This defect often occurs due to irregular brain development.

Provigil and Nuvigil microcephaly cases have been reported and could lead to lifelong learning disabilities. According to the CDC, there is no known cure or standard treatment for microcephaly.

Results of the Nuvigil/Provigil Pregnancy Registry

The Nuvigil/Provigil Pregnancy Registry included up to 300 people. They were exposed to either of these sleep-disorder medications while pregnant, or they had been exposed within six weeks prior to becoming pregnant.

This chart provides clear evidence of Provigil and Nuvigil birth defects. It shows why pregnant women should not take either drug, and why women who could potentially become pregnant should use effective contraception if they are taking either sleep-disorder medication.

The registry’s 2018 Annual Report revealed a link between “major congenital malformations” and using either modafinil or armodafinil. According to Teva Pharmaceuticals:

Provigil or Nuvigil birth defects occurred in approximately 15% of cases where either medication was used during, or right before, pregnancy.

By comparison, the rate of major birth defects is 3% for the general population.

Other Common Provigil and Nuvigil Side Effects

There are other common Provigil and Nuvigil side effects, which range in severity. Some of the frequent mild side effects shared by these two drugs include headache, nausea, insomnia and dizziness.

The FDA states that Provigil also can cause diarrhea, anxiety, back pain and indigestion. The website Healthline states Nuvigil can cause diarrhea and anxiety as well, and Provigil can cause congestion.

There are more severe Provigil and Nuvigil side effects. Some of the more common ones include severe rashes (a condition called “Stevens-Johnson Syndrome”), chest pain and difficulty breathing.

Psychological Disorders From Taking Provigil or Nuvigil

There are psychological or mental disorders associated with using either Provigil or Nuvigil. According to numerous online medical sources, the most common disorders are:

Depression

Anxiety

Nervousness

Hallucinations

Suicidal thoughts

Provigil and Nuvigil Side Effects, Birth Defects, and Injuries