People with certain types of long-term sleep disorders feel extremely tired during the day, a condition known as excessive daytime sleepiness (EDS). There are many medicines that work in different ways to help make people with these conditions feel less sleepy during the day.
Provigil (modafinil) is a medicine taken during the day that is approved to help with EDS in people who have narcolepsy, obstructive sleep apnea, or shift work sleep disorder.
How Does Provigil 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 have 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 the 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 have 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 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. Provigil contains a medicine called modafinil, which helps to reduce sleepiness by stimulating the brain. It is not entirely clear exactly how Provigil 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?
Provigil 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 an hour before they go to work.
It is important to take this medicine exactly as prescribed. If you take it 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 Provigil, speak with your health care provider before making any changes.
How Was It Studied for Narcolepsy, and What Were the Benefits?
Two studies were done to see if Provigil was safe and effective for adults with excessive sleepiness caused by narcolepsy. Everyone had narcolepsy, and about 80% of the people in the two studies also had cataplexy attacks.
The people in these studies were between the ages of 17 and 68, with an average age of 42. About half (54%) were female and about half (46%) were male, most (83%) were White, 14% were Black or African American, and about 2.5% were Hispanic. The race of the other people in the studies was reported as “other.”
Everyone took Provigil or a placebo every morning for nine 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 or to prevent cataplexy attacks.
Both studies 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 studies and their health care providers also completed many other surveys and scales to measure changes in their symptoms.
After 9 weeks in the studies:
- People taking Provigil were able to stay awake for an extra 2.2 minutes, on average, more than they were before the study started. On the other hand, the people taking a placebo were able to stay awake for 0.7 minutes LESS than they were before the studies started. These results show that Provigil is effective for reducing excessive daytime sleepiness in people with narcolepsy.
- People taking Provigil had lower sleepiness scores than people taking a placebo.
- Health care providers were more likely to see an improvement in overall health in the people taking Provigil. About 58%-72% of people taking Provigil were rated as “improved,” compared to 37%-38% of people taking a placebo.
How Was It Studied for Obstructive Sleep Apnea (OSA), and What Were the Benefits?
One study was done to see if Provigil 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 this study were between the ages of 18 and 70, with an average age of 50. About three-quarters (76%) of them were male. Race was not reported for this study.
The people in this study took Provigil or a placebo every morning for 12 weeks while continuing to use their airway pressure device. 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 the same tests as the study in people with narcolepsy.
After 12 weeks in this study:
- People taking Provigil were able to stay awake for an extra 1.5 minutes, on average, more than they were before the study started. On the other hand, the people taking a placebo were able to stay awake for 1.1 minutes LESS than they were before the study started. These results show that Provigil is effective for reducing excessive daytime sleepiness in people with narcolepsy.
- People taking Provigil had lower sleepiness scores than people taking a placebo. Some people had their scores drop so low that they were no longer considered to have excessive sleepiness. This happened for 38%-45% of people taking Provigil and 17% of people taking a placebo.
- Health care providers were more likely to see an improvement in overall health in the people taking Provigil. About 61%-68% of people taking Provigil were rated as “improved,” compared to 37% of people taking a placebo.
How Was It Studied for Shift Work Sleep Disorder (SWSD), and What Were the Benefits?
One study was done to see if Provigil 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 and 60, with an average age of 38. A little more than half (61%) were male and less than half (39%) were female. Around two-thirds (67%) were White, about one-quarter (25%) were Black, and less than 1% were Asian. The race of the other people in the study was reported as “other.”
The people in this study took Provigil or a placebo about 30-60 minutes before the start of each night shift for 12 weeks. This means that they did not take a dose every night. No one knew 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 2 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 Provigil were able to stay awake for an extra 1.7 minutes, on average, more than they were before the study started. People taking a placebo were able to stay awake for an extra 0.3 minutes, on average, more than they were before the study started. These results show that Provigil is effective for reducing excessive daytime sleepiness in people with narcolepsy.
- Health care providers were more likely to see an improvement in the overall sleepiness of people taking Provigil. About three-quarters (74%) of people taking Provigil were rated as “improved,” compared to 36% of people taking a placebo.
- Compared to those taking a placebo, people taking modafinil also had fewer lapses in attention and reported fewer accidents or near-accidents while commuting to or from work.
How Quickly Will Provigil Work?
If Provigil 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 more alert and more able to stay awake during the day. It is important not to change any of your other medicines while you are taking Provigil. If you have OSA, it is important to keep using your airway pressure device every night.
Do not stop Provigil or change the dose of any of your medicines without talking to your health care provider first. If you are concerned that Provigil is not working for you, speak with your health care provider about your options.
How Can I Prevent or Manage Side Effects?
Provigil 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, liver problems, or substance abuse. This will help them to decide whether it is safe for you to use this medicine.
Some people who take Provigil may have headaches or other types of pain, such as back pain. These types of pain can usually be treated with over-the-counter pain medicines. Talk to your pharmacist to find the best option for you. If you get chest pain while taking Provigil, contact your health care provider right away.
Provigil may cause behavior and mood changes in some people, such as becoming anxious, agitated, nervous, or cranky. 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.
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 have any symptoms that you think may be caused by Provigil, 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, Provigil may make your birth control less effective. Talk with your health care provider about your options. A non-hormonal form of birth control should be used while taking Provigil and for at least one month after stopping the medicine.
Provigil 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 Provigil?
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 Provigil. It is important to know whether Provigil 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 Provigil. Although there are no studies to confirm whether drinking alcohol with Provigil is safe, there are many potential risks with this combination.
What Are Other Unique Considerations to Be Aware Of?
Provigil is a schedule IV medicine, which means it has a high risk of abuse and misuse. You should always keep Provigil 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.
