Waklert

Waklert is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

Limitations of Use

In OSA, Waklert is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Waklert for excessive sleepiness.

Waklert (Waklert) is a medication that promotes wakefulness.

Waklert is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Waklert may also be used for purposes not listed in this medication guide.

Dosage In Obstructive Sleep Apnea (OSA) And Narcolepsy

The recommended dosage of Waklert for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.

In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose.

Dosage In Shift Work Disorder (SWD)

The recommended dosage of Waklert for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modification In Patients With Severe Hepatic Impairment

In patients with severe hepatic impairment, the dosage of Waklert should be reduced.

Use In Geriatric Patients

Consideration should be given to the use of lower doses and close monitoring in geriatric patients.

How supplied

Dosage Forms And Streng

• 50 mg – round, white to off-white tablet with C on one side and “205” on the other
• 150 mg – oval, white to off-white tablet with C on one side and “215” on the other
• 200 mg – rounded, rectangular, white to off-white tablet with C on one side and “220” on the other
• 250 mg – oval, white to off-white tablet with on one side and “225” on the other

Storage And Handling

Waklert® (Waklert) Tablets are available as follows:

50 mg: Each round, white to off-white tablet is debossed with C on one side and “205” on the other. NDC 63459-205-30 – Bottles of 30

150 mg: Each oval, white to off-white tablet is debossed with C on one side and “215” on the other. NDC 63459-215-30 – Bottles of 30

200 mg: Each rounded, rectangular, white to off-white tablet is debossed with C on one side and “220” on the other. NDC 63459-220-30 – Bottles of 30

250 mg: Each oval, white to off-white tablet is debossed with C on one side and “225” on the other. NDC 63459-225-30 – Bottles of 30

Storage

Store at 20°- 25C (68°- 77°F).

Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised April 2015

See also:
What is the most important information I should know about Waklert?

You should not use this medication if you are allergic to Waklert or modafinil (Provigil).

Before using Waklert, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, a heart valve disorder, a history of mental illness, a history of drug or alcohol addiction, or if you have recently had a heart attack.

Waklert may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Stop taking Waklert and call your doctor if you have a skin rash, no matter how mild. A medicine similar to Waklert has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.

There may be other drugs that can interact with Waklert. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Use Waklert as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Waklert comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Waklert refilled.
• Take Waklert by mouth with or without food.
• Your doctor will tell you what time of day to take Waklert. Do not change the time of day you take it without talking to your doctor.
• If you miss a dose of Waklert, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Waklert.

Use: Labeled Indications

Narcolepsy: To improve wakefulness in patients with excessive sleepiness associated with narcolepsy.

Obstructive sleep apnea: To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea (OSA).

Limitations of use: In OSA, Waklert is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Waklert for excessive sleepiness.

Shift-work disorder: To improve wakefulness in patients with excessive sleepiness associated with shift-work disorder.

See also:
What other drugs will affect Waklert?

Effects of Waklert on CYP3A4/5 Substrates

The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by Waklert via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with Waklert.

The effectiveness of steroidal contraceptives may be reduced when used with Waklert and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with Waklert and for one month after discontinuation of Waklert treatment.

Blood levels of cyclosporine may be reduced when used with Waklert. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with Waklert.

Effects of Waklert on CYP2C19 Substrates

Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by Waklert via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with Waklert.

Warfarin

More frequent monitoring of prothrombin times/INR should be considered whenever Waklert is coadministered with warfarin.

Monoamine Oxidase (MAO) Inhibitors

Caution should be used when concomitantly administering MAO inhibitors and Waklert.

Drug Abuse And Dependence

Controlled Substance

Waklert contains Armodafinil, a Schedule IV controlled substance.

Abuse

Although the abuse potential of Waklert has not been specifically studied, its abuse potential is likely to be similar to that of modafinil. In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like. Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior).

The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).

See also:
What are the possible side effects of Waklert?

Applies to Waklert: oral tablet

As well as its needed effects, Waklert (the active ingredient contained in Waklert) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Waklert, check with your doctor immediately:

Less common:

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficult or labored breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• frequent urination
• headache, severe and throbbing
• increased volume of pale, dilute urine
• itching, scaling, severe redness, soreness, or swelling of the skin
• rash
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• tightness in the chest
• trembling or shaking of the hands or feet
• wheezing

If any of the following symptoms of overdose occur while taking Waklert, get emergency help immediately:

Symptoms of overdose:

• Anxiety
• blurred vision
• chest pain or discomfort
• confusion about identity, place, and time
• diarrhea
• dry mouth
• headache
• hyperventilation
• irritability
• lightheadedness, dizziness, or fainting
• nausea
• nervousness
• pounding in the ears
• restlessness
• seeing, hearing, or feeling things that are not there
• sleeplessness
• slow heartbeat
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness

Minor Side Effects

Some Waklert side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Acid or sour stomach
• belching
• chills
• cough
• depression
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• general feeling of discomfort or illness
• heartburn
• indigestion
• joint pain
• loss of appetite
• loss of interest or pleasure
• mood or mental changes
• muscle aches and pains
• runny nose
• shivering
• sore throat
• stomach discomfort, upset, or pain
• sweating
• thirst
• tiredness
• trouble concentrating
• vomiting
• weight loss

Waklert is the enantiopure of the wakefulness-promoting agent modafinil (Provigil), and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Research has shown that Waklert significantly improves driving simulator performance in patients with SWD. Waklert consists of the (−)-R-enantiomer of the racemic modafinil. Waklert is produced by the pharmaceutical company Cephalon Inc. (a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.) and was approved by the U.S. Food and Drug Administration (FDA) in June 2007.