What is the most important information I should know about modalert?

Use caution when driving, operating machinery, or performing other hazardous activities. Modalert may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities. It is best to avoid alcohol while taking modalert. Alcohol or modalert may have altered effects if taken together.

Modalert may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking modalert, and for one month after stopping modalert, if prevention of pregnancy is desired.

Modalert may be habit forming. You should discuss the abuse and dependence potential of modalert with your doctor. Do not stop taking modalert without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.

What is modalert?

The exact way that modalert works is not known.

Modalert is used to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/hypoapnea syndrome (OSAHS), and shift work sleep disorder (SWSD).

Modalert may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking modalert?

Before taking modalert, tell your doctor if you have

• left ventricular hypertrophy (enlarged left heart ventricle);
• chest pain, irregular heartbeats, or other symptoms of mitral valve prolapse due to central nervous system stimulant use;
• a recent history of a heart attack;
• high blood pressure;
• angina (chest pain);
• abused medicines called stimulants or street drugs;
• a history of mental illness;
• kidney disease; or
• liver disease.

You may not be able to take modalert, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Modalert is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take modalert without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether modalert passes into breast milk. Do not take modalert without first talking to your doctor if you are breast-feeding. If you are older than 65 years of age, you may be more likely to experience side effects from modalert. You may require a lower dose or special monitoring during treatment.

How should I take modalert?

Take modalert exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Modalert can be taken with or without food.

Modalert is usually taken once a day. Follow your doctor's instructions.

It is important to take modalert regularly to get the most benefit.

Modalert is not a replacement for sleep. Modalert may reduce the signs of sleepiness, but may not completely treat this problem. Some drowsiness may continue. Potentially hazardous activities such as driving or operating machinery should only be performed if the level of wakefulness achieved is sufficient to permit such activities.

Other treatments such as CPAP (continuous positive airway pressure) use should be continued as directed by your doctor if you have obstructive sleep apnea/hypoapnea syndrome (OSAHS) and are taking modalert.

Modalert may be habit forming. You should discuss the abuse and dependence potential of modalert with your doctor. Do not stop taking modalert without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment. Store modalert at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember as directed by your doctor. A missed dose taken late in the waking day may cause insomnia. If you don't remember until it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a modalert overdose may include excitation, agitation, insomnia, sleep disturbances, anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, nausea, and diarrhea.

What should I avoid while taking modalert?

Use caution when driving, operating machinery, or performing other hazardous activities. Modalert may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities. It is best to avoid alcohol while taking modalert. Alcohol or modalert may have altered effects if taken together.

Modalert may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking modalert, and for one month after stopping modalert, if prevention of pregnancy is desired.

What are the possible side effects of modalert?

If you experience any of the following uncommon but serious side effects, stop taking modalert and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• irregular heartbeats;
• low or high blood pressure; or
• shortness of breath.

Other, less serious side effects may be more likely to occur. Continue to take modalert and talk to your doctor if you experience

• headache;
• infection;
• nausea, decreased appetite, or diarrhea;
• chills;
• dry mouth;
• runny nose;
• sore throat;
• nervousness;
• anxiety;
• dizziness;
• insomnia;
• depression; or
• numbness or tingling.

Modalert may be habit forming. You should discuss the abuse and dependence potential of modalert with your doctor. Do not stop taking modalert without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect modalert?

Modalert may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking modalert, and for one month after stopping modalert, if prevention of pregnancy is desired.

Before taking modalert, tell your doctor if you are taking any of the following drugs:

• a monoamine oxidase inhibitor (MAO inhibitor) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil);
• a tricyclic antidepressant such as clomipramine (Anafranil) or desipramine (Norpramin);
• another CNS stimulant such as amphetamine-dextroamphetamine (Adderall), methylphenidate (Ritalin, Methylin, Metadate ER, Concerta), pemoline (Cylert), and others;
• phenytoin (Dilantin);
• carbamazepine (Tegretol);
• phenobarbital;
• rifampin (Rifadin, Rimactane);
• ketoconazole (Nizoral);
• itraconazole (Sporanox);
• cyclosporine (Neoral, Sandimmune);
• theophylline (Theolair, Theochron, Theo-Bid, Theo-Dur, Elixophyllin, Slo-Phyllin, and others);
• warfarin (Coumadin);
• diazepam (Valium); or
• propranolol (Inderal).

You may not be able to take modalert, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with modalert. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.