1. What is NUVIGIL ® and what is it used for?
NUVIGIL® is in the form of a white or whitish oval tablet. It is presented as 30 tablets in each box, blister pack.
NUVIGIL® is used to increase wakefulness in adult patients with hypersomnia prone to sleep disorders caused by one of the following diagnosed sleep disorders.
• Narcolepsy (sleeping sickness)
• Obstructive sleep apnea; NUVIGIL® is used in combination with other medical treatments for this sleep disorder. NUVIGIL® does not replace a CPAP (continuous positive airway pressure) machine or any other treatment prescribed by your doctor. It is important that you continue to take these treatments as prescribed by your doctor.
• Sleep disorder due to shift work
NUVIGIL® will not improve these sleep disorders. NUVIGIL® will help with the sleepiness caused by these sleep disorders, but it may not completely stop your sleepiness. NUVIGIL® is not a substitute for adequate sleep. Follow your doctor’s advice on good sleep habits and the use of other treatments.
2. What are the possible side effects?
Like all medicines, there may be side effects in people who are sensitive to the substances in NUVIGIL®.
If any of the following occur, stop using NUVIGIL® and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:
• Serious rash and severe allergic reaction
– Skin rash, hives, mouth sores, skin blisters and peeling
– swelling of the face, eyes, lips, tongue or throat
– Trouble swallowing and breathing
– fever, shortness of breath, swollen feet, yellowing of the skin or whites of the eyes, or dark urine
These are all very serious side effects. If you have any of these, you have a serious allergy to NUVIGIL. You may need emergency medical attention or hospitalization.
• Mental symptoms
– Mental (psychiatric) symptoms including depression, anxiety (worry), hearing, seeing, feeling or perceiving things that are not present (hallucination), excessive increase in activity and speech (mania), suicidal ideation, aggression and other mental problems
• Symptoms of heart problems
– Heart problems including chest pain, abnormal heartbeats and trouble breathing. These are all very serious side effects. You may need emergency medical attention or hospitalization.