If you have a long-term sleep disorder that causes excessive daytime sleepiness (EDS), you may need to take medicines to manage your symptoms. The different medicines available for these conditions work in different ways to help you feel less sleepy during the day.
Nuvigil (armodafinil), which is taken during the day, is approved to help with EDS in people with narcolepsy, obstructive sleep apnea, or shift work sleep disorder.
How Does Nuvigil Work for Certain Chronic Sleep Disorders?
Although many people struggle with drowsiness and getting enough sleep at some point in their lives, some people have sleep disorders that cause chronic (long-term) issues with sleep. These sleep disorders can cause people to feel very tired and even fall asleep during the day, so they are often referred to as conditions that cause excessive daytime sleepiness (EDS).
One of these disorders, narcolepsy, causes extreme sleepiness during the day, which makes it hard to focus and stay awake. As a result, many people with narcolepsy fall asleep without warning, even if they are in the middle of an activity. Many people with narcolepsy also experience something called cataplexy. During a cataplexy attack, a person suddenly loses muscle control. This can cause all types of issues, depending on which muscles are affected, from drooping eyelids to a hard time speaking to not being able to move at all. These attacks are most often caused by strong emotions and typically last for about one to two minutes.
Some people who work unusual hours, such as a night shift, may develop shift work sleep disorder (SWSD). People with this condition often have trouble falling asleep or staying asleep. They also often feel very tired when they are at work overnight or in the early morning hours. Many people who switch to an unusual work schedule will experience sleep issues for a few weeks as their bodies begin to adjust. But people with SWSD still have trouble falling asleep and staying awake after three or more months.
Obstructive sleep apnea (OSA) is another common cause of long-term sleep issues. In people with OSA, part of the airway becomes blocked during sleep. This causes the lungs to work harder and can lead to the body getting less oxygen during sleep. OSA can cause many different health issues, including extreme sleepiness during the day.
Getting more sleep at night does not always help with the symptoms of these conditions, so treatment may include different types of medicines. Nuvigil contains a medicine called armodafinil, which helps to reduce sleepiness by stimulating the brain. It is not entirely clear exactly how Nuvigil works as a stimulant. It seems to copy the activity of brain chemicals that act like adrenaline and increase the activity of another brain chemical called dopamine.
How Do I Use It?
Nuvigil is a tablet that is taken by mouth once every day. People with narcolepsy or obstructive sleep apnea (OSA) should take this medicine in the morning after waking up. People with shift work sleep disorder (SWSD) should take this medicine about one hour before they go to work.
It is important to take this medicine exactly as prescribed. If you take Nuvigil too close to when you want to go to bed, you may have trouble falling asleep. Some people may benefit from setting an alarm to remind them to take the medicine. If you think that you may need to change the time of day that you take your Nuvigil, speak with your health care provider before making any changes.
How Was It Studied for Narcolepsy and What Were the Benefits?
One study was done to see if Nuvigil was safe and effective for adults with excessive sleepiness caused by narcolepsy. All of the people in this study had narcolepsy and two-thirds (66%) also had cataplexy attacks.
The people in the study were between the ages of 18-65, with an average age of 35-40. A little more than half (56%) were female, about three-quarters (73%) were White, and about one-fifth (17%) were Black. The race of the other people in the study was reported as “other” or “missing.”
The people in this study took Nuvigil or placebo every morning for 12 weeks. They did not know whether they were taking the medicine or the placebo. No one was allowed to take other medicines to treat their daytime sleepiness.
This study measured efficacy using a test called the Maintenance of Wakefulness Test (MWT). This test measures how long a person can stay awake while seated in a recliner in a dark room between the hours of 9 a.m. and 3 p.m. The people in the study and their health care providers also completed many other surveys and scales to measure changes in their symptoms.
After 12 weeks in the study:
- People taking Nuvigil were able to stay awake for an extra 1.9 minutes, on average, than they were before the study started. On the other hand, people taking placebo were able to stay awake for 1.9 minutes LESS than they were before the study started. These results show that Nuvigil is effective for reducing excessive daytime sleepiness in people with narcolepsy.
- People taking Nuvigil had lower sleepiness scores than people taking placebo. Some people had their scores drop so low that they were no longer considered to have excessive sleepiness. This happened for 21%-28% of people taking Nuvigil and 7% of people taking placebo.
- Health care providers were more likely to see an improvement in overall health in the people taking Nuvigil. About 69%-73% of people taking Nuvigil were rated as “improved,” compared to 33% of people taking placebo.
How Was It Studied for Obstructive Sleep Apnea (OSA) and What Were the Benefits?
Two studies were done to see if Nuvigil was safe and effective for adults with excessive sleepiness caused by OSA. Everyone in the study had OSA and still had excessive sleepiness even though they had been using an airway pressure device (CPAP) every night while sleeping for at least a month before the study started.
All of the people in these studies were between the ages of 18-65, with an average age of 50. Almost three-quarters (72%) of them were male and most (85%) were White. The race of the other people in the study was reported as “other.”
The people in these studies took Nuvigil or placebo every morning for 12 weeks while continuing to use their airway pressure device every night. They did not know whether they were taking the medicine or the placebo.
This study measured efficacy using the same tests as the study in people with narcolepsy.
After 12 weeks in these studies:
- People taking Nuvigil were able to stay awake for an extra 1.7 to 2.3 minutes, on average, than they were before the study started. On the other hand, people taking placebo were able to stay awake for 1.5 minutes LESS than they were before the study started. This means that Nuvigil helped people to stay awake longer when seated in a comfortable position in a dark room during the day.
- People taking Nuvigil had lower sleepiness scores and lower fatigue scores than people taking placebo.
- Health care providers were more likely to see an improvement in the overall health of people taking Nuvigil. About 71%-74% of people taking Nuvigil were rated as “improved,” compared to 37%-53% of people taking placebo.
How Was It Studied for Shift Work Sleep Disorder (SWSD) and What Were the Benefits?
One study was done to see if Nuvigil was safe and effective for adults with excessive sleepiness caused by SWSD. All of the people in the study worked at least five night shifts each month and had moderate or severe sleepiness on work nights.
The people in the study were between the ages of 18-65, with an average age of 39. About half (53%) were male and about half (47%) were female. Around two-thirds (65%) were White, about one-quarter (26%) were Black, and less than 2% were Asian or Pacific Islander. The race of the other people in the study was reported as “other.” More than one-quarter (28%) of the people in the study dropped out before the study ended, but none of these dropouts were due to a lack of benefit.
The people in this study took Nuvigil or placebo about 30-60 minutes before the start of each night shift for 12 weeks. This means that they did not take the medicine every night. On average, they took a dose on about 20% of the nights during the 12 weeks in the study. They did not know whether they were taking the medicine or the placebo.
This study measured efficacy using a test called the Multiple Sleep Latency Test (MSLT). This test measures how long a person can stay awake while seated in a recliner in a dark room between the hours of midnight and 8 a.m. The people in the study and their health care providers also completed many other surveys and scales to measure changes in their symptoms.
After 12 weeks in the study:
- People taking Nuvigil were able to stay awake for an extra 3.1 minutes, on average, than they were before the study started. People taking placebo were able to stay awake for an extra 0.4 minutes, on average, than they were before the study started. This means that Nuvigil helped people to stay awake longer when seated in a comfortable position in a dark room between midnight and 8 a.m.
- People taking Nuvigil had lower sleepiness scores than people taking placebo.
- Health care providers were more likely to see an improvement in the overall symptoms of people taking Nuvigil. About 79% of people taking Nuvigil were rated as “improved,” compared to 59% of people taking placebo.
How Quickly Will Nuvigil Work?
If Nuvigil is working for you, you may notice a change in how sleepy you feel within the first month. If you have narcolepsy or OSA, it may take two to three months to notice the full effects of the medicine, such as feeling less tired and more able to stay awake during the day. It is important not to change any of your other medicines while you are taking Nuvigil. If you have OSA, it is important to keep using your airway pressure device every night.
Do not stop taking Nuvigil or change your dose without talking to your health care provider first. Stopping Nuvigil suddenly may cause serious side effects. If you are concerned that the medicine is not working, speak with your health care provider about your options.
How Can I Prevent or Manage Side Effects?
Nuvigil may not be the right option for some people. Let your health care provider know about any medical conditions you have had in the past, including mental health disorders, heart problems, high blood pressure, liver problems, or substance abuse. This will help them to decide whether it is safe for you to use this medicine.
Nuvigil may cause behavior and mood changes in some people, such as becoming anxious, agitated, nervous, or irritable. Some people have also become depressed and have had suicidal thoughts. Following a daily schedule that includes exercise and a well-balanced diet can help with this. It may also help to write down how you are feeling and keep track of your moods and mental state.
Some people who use Nuvigil may have changes in their heart rate or blood pressure. Your health care provider may monitor your heart rate and blood pressure during your regular office visits or ask you to monitor them at home. Let your health care provider know if your heart rate or blood pressure increases while you are using this medicine.
Nuvigil may cause headaches that can usually be treated with over-the-counter (OTC) pain medicines. Talk to your pharmacist to find the best option for you. If you experience other forms of serious pain, such as chest pain, contact your health care provider right away.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Nuvigil, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Are There Any Interactions With Other Medicines?
If you are using a hormonal birth control method, Nuvigil may make your birth control less effective. Talk with your health care provider about your options. A nonhormonal form of birth control should be used while taking Nuvigil and for at least one month after stopping the medicine.
Nuvigil can also alter the blood levels of many other medicines. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them to find the best treatment plan for you.
Is There Anything Else I Should Avoid While Using Nuvigil?
Due to your sleep disorder, your health care provider may have already warned you to be cautious about driving, operating heavy machinery, or doing any other activities that require alertness and coordination.
You should continue to use caution with these activities even after you have started taking Nuvigil. It is important to know whether Nuvigil is working for you, and whether it causes any side effects such as dizziness, before you make any changes to your daily activities. Some signs that you are not safe to drive or perform these activities include being very dizzy, drowsy, unusually clumsy, or falling asleep unexpectedly.
It is best to avoid drinking alcohol while you are taking Nuvigil. Although there are no studies to confirm whether drinking alcohol with Nuvigil is safe, there are many potential risks with this combination.
What Are Other Unique Considerations to Be Aware Of?
Nuvigil is a schedule IV medicine, which means it has a high risk of abuse and misuse. You should always keep Nuvigil in a safe, locked place and should not share it with other people. Let your health care provider know if you have a history of substance abuse or misuse, including with alcohol, opioids, or recreational drugs.
Nuvigil can also cause physical dependence, which means that stopping the medicine may cause symptoms of withdrawal. Some people have reported shaking, sweating, chills, nausea, vomiting, confusion, and a rapid heartbeat after stopping Nuvigil suddenly. If you are considering stopping your medicine, speak with your healthcare provider first.
