Nuvigil

Sleepiness, Narcolepsy, Sleep Disorders, Circadian Rhythm
Treatment
5 FDA approvals
14 Active Studies for Nuvigil

What is Nuvigil

ArmodafinilThe Generic name of this drug
Treatment SummaryArmodafinil is a prescription medication used to treat excessive sleepiness associated with obstructive sleep apnea, narcolepsy, or shift work disorder. It is the R-enantiomer of the wakefulness-promoting agent modafinil and has been approved by the FDA since 2007. Armodafinil has been shown to help improve driving simulator performance in people with shift work disorder. The drug is manufactured by Cephalon Inc (a subsidiary of Teva Pharmaceutical Industries Ltd).
Nuvigilis the brand name
image of different drug pills on a surface
Nuvigil Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Nuvigil
Armodafinil
2009
66

Approved as Treatment by the FDA

Armodafinil, commonly known as Nuvigil, is approved by the FDA for 5 uses which include Shift-work related sleep disturbance and Somnolence .
Shift-work related sleep disturbance
Helps manage Shift-work related sleep disturbance
Somnolence
Helps manage Somnolence
Narcolepsy
Helps manage Narcolepsy
Sleep Disorders, Circadian Rhythm
Helps manage Shift-work related sleep disturbance
Sleepiness
Helps manage Somnolence

Effectiveness

How Nuvigil works in the bodyNuvigil (armodafinil) is a stimulant that helps people stay awake and alert for longer periods of time. We don't know exactly how it works, but it does not interact with several key receptors and enzymes that are related to wake/sleep regulation. Armodafinil does bind to the dopamine transporter and stops dopamine from being reabsorbed, which likely plays a role in its effects.

When to interrupt dosage

The prescribed measure of Nuvigil is contingent upon the recognized condition, including Narcolepsy, Shift-work related sleep disturbance and Somnolence. The amount of dosage is contingent upon the approach of administration outlined in the below table.
Condition
Dosage
Administration
Sleepiness
, 250.0 mg, 50.0 mg, 100.0 mg, 200.0 mg, 150.0 mg
Oral, , Tablet, Tablet - Oral
Narcolepsy
, 250.0 mg, 50.0 mg, 100.0 mg, 200.0 mg, 150.0 mg
Oral, , Tablet, Tablet - Oral
Sleep Disorders, Circadian Rhythm
, 250.0 mg, 50.0 mg, 100.0 mg, 200.0 mg, 150.0 mg
Oral, , Tablet, Tablet - Oral

Warnings

There are 20 known major drug interactions with Nuvigil.
Common Nuvigil Drug Interactions
Drug Name
Risk Level
Description
Anagrelide
Major
The metabolism of Anagrelide can be increased when combined with Armodafinil.
Bendamustine
Major
The metabolism of Bendamustine can be increased when combined with Armodafinil.
Cabozantinib
Major
The metabolism of Cabozantinib can be decreased when combined with Armodafinil.
Capecitabine
Major
The metabolism of Capecitabine can be decreased when combined with Armodafinil.
Capmatinib
Major
The serum concentration of Capmatinib can be decreased when it is combined with Armodafinil.
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Nuvigil Novel Uses: Which Conditions Have a Clinical Trial Featuring Nuvigil?

Currently, 13 trials are underway to assess the potential of Nuvigil to alleviate Shift-work related sleep disturbance, Somnolence and Narcolepsy.
Condition
Clinical Trials
Trial Phases
Sleep Disorders, Circadian Rhythm
4 Actively Recruiting
Not Applicable, Phase 3, Phase 1
Narcolepsy
2 Actively Recruiting
Not Applicable, Phase 1
Sleepiness
4 Actively Recruiting
Not Applicable, Phase 3

Nuvigil Reviews: What are patients saying about Nuvigil?

5Patient Review
9/30/2016
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
This medication has been a life-saver, helping me to stay awake and alert while driving at early morning hours during the week. I have experienced no adverse side effects from taking Nuvigol for over a year, and my sleep patterns have also dramatically improved.
5Patient Review
10/5/2019
Nuvigil for Recurring Sleep Episodes During the Day
I've only taken the nuvigil twice and both times I experienced anxiety, sweating, and more anxiety. I'm hoping this is just a normal side effect that will pass with time. So far, it's keeping me awake which is great. But I worry about the other effects.
5Patient Review
6/1/2017
Nuvigil for Sleepiness Due To Shift Work Sleep Disorder
The pro of this drug is that it really helped me stay awake during the day. The con was that I got horrible headaches and felt exhausted by the end of the day.
5Patient Review
1/17/2016
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
5Patient Review
7/21/2016
Nuvigil for Sleepiness Due To Shift Work Sleep Disorder
This medication has helped me a lot. It's easy to remember to take it in the morning, and I haven't had any problems with side effects.
5Patient Review
6/9/2017
Nuvigil for Recurring Sleep Episodes During the Day
I take this medication a half hour before my night shift, and it allows me to stay fully alert and focused for the entire duration.
4.3Patient Review
7/1/2016
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
Nuvigil is great for me because I'm very sensitive to stimulants. It doesn't make me anxious or give me palpitations like other drugs do; instead it just keeps me more awake and full of energy.
4Patient Review
7/13/2018
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
Though it's a bit pricey, I found this treatment completely worth the investment.
3.7Patient Review
2/6/2016
Nuvigil for Sleepiness Due To Shift Work Sleep Disorder
I experienced great results for the first two days of taking this medication. However, after that I started having migraines, dizziness, breathing difficulties, and an irregular heartbeat. Needless to say, I won't be continuing to take it.
3.3Patient Review
5/7/2019
Nuvigil for Sleepiness Due To Shift Work Sleep Disorder
I started taking this once daily, but then began experiencing heart palpitations, chest tightness and shortness of breath. My cardiologist ruled out any underlying cardiac conditions, but all of my symptoms were related to this medication. I'm now much more careful about when I take it and have had no further problems.
3.3Patient Review
12/7/2020
Nuvigil for Recurring Sleep Episodes During the Day
I've been using this medication for about a month now, and it seems to be working well. I have noticed that I'm not as emotionally stable as I used to be, and I get easily triggered when someone interrupts me. Also started getting headaches about a week ago, but those could be unrelated.
1.7Patient Review
4/5/2016
Nuvigil for Recurring Sleep Episodes During the Day
I find that this medication is most effective on the days when I don't take it and just sleep all day.
1Patient Review
9/25/2021
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
I didn't have a good experience with this medication. It made me feel jittery, angry, and extremely sleepy, and I also got headaches from it.
1Patient Review
10/22/2020
Nuvigil for Sleepiness Due To Obstructive Sleep Apnea
Nuvigil was helpful for me at first, but it's stopped being effective in the last year or so. I'm currently discussing alternatives with my doctor.
1Patient Review
1/11/2016
Nuvigil for Recurring Sleep Episodes During the Day
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Patient Q&A Section about nuvigil

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Nuvigil make you feel?

"The doctor warned me that Nuvigil could make me feel "jittery". As someone who is naturally jittery and takes an anti-anxiety medication, I was skeptical. I decided to do a sleep study to see if the drug would help me."

Answered by AI

What is Nuvigil used to treat?

"Armodafinil helps to reduce extreme sleepiness that is caused by narcolepsy and other sleep disorders, like when you stop breathing during sleep (obstructive sleep apnea)."

Answered by AI

Is Nuvigil the same as Adderall?

"What is the difference between Armodafinil and Adderall?

Armodafinil is similar to Adderall in that they can both improve wakefulness and alertness; however, they work differently in the brain and affect different chemicals. Armodafinil is classified as a controlled medication differently than Adderall."

Answered by AI

What does Nuvigil do to the brain?

"Nuvigil and Provigil help to Wake people up by stimulating certain areas of the brain. These drugs can be used to treat narcolepsy, Sleep apnea, and shift work disorder."

Answered by AI

Clinical Trials for Nuvigil

Image of NYU Langone Health in New York, United States.

Transcranial Photobiomodulation for Obstructive Sleep Apnea

55 - 75
All Sexes
New York, NY
Obstructive sleep apnea (OSA) is a sleep disorder that is commonly treated using positive airway pressure, yet 50% of patients still experience residual sleepiness after successful therapy. A potential neuromodulation strategy that can decrease residual sleepiness is transcranial photobiomodulation (tPBM). tPBM is a neuromodulatory treatment that uses red and/or near infrared light to penetrate the cortex and can alter both cerebral metabolism and blood flow. However, this potential has never been explored before directly in sleep disordered individuals. This project aims to explore the effect of tPBM on sleepiness and understand the potential neural mechanism of tPBM in OSA. The short-term goal of this project is to collect pilot data, which is the first of its kind, and suggest tPBM as a potential modulator of sleepiness in OSA.
Waitlist Available
Has No Placebo
NYU Langone HealthNaomi Gaggi
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PROSOMNIA Sleep Therapy for Chronic Insomnia

18 - 65
All Sexes
Aventura, FL
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.
Phase 1
Waitlist Available
PROSOMNIA Sleep Health and Wellness (+1 Sites)Nyree Penn, MHSc., CAA, Master of Health ScienceNyree Penn
Have you considered Nuvigil clinical trials? We made a collection of clinical trials featuring Nuvigil, we think they might fit your search criteria.Go to Trials
Have you considered Nuvigil clinical trials? We made a collection of clinical trials featuring Nuvigil, we think they might fit your search criteria.Go to Trials
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Sleep Apnea Treatments for Sleep Apnea with COPD

60 - 89
All Sexes
Detroit, MI
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
Recruiting
Has No Placebo
John D. Dingell VA Medical Center, Detroit, MISusmita Chowdhuri, MD MS
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