Waklert is a prescription medication containing the active pharmaceutical ingredient Armodafinil, a non-amphetamine eugeroic agent specifically designed to promote wakefulness. It is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). As an enantiomerically pure form of modafinil, it offers a refined pharmacological profile with a longer half-life, providing sustained alertness and improved cognitive function for patients struggling with pathological somnolence. Its mechanism of action, while not fully elucidated, is believed to involve selective activation of wake-promoting centers in the hypothalamus, distinguishing it from traditional stimulants.

Features

• Active Ingredient: Armodafinil (R-enantiomer of modafinil)
• Standard Dosage Form: Oral tablets (50 mg, 150 mg, 250 mg)
• Pharmacological Class: Eugeroic (Wakefulness-Promoting Agent)
• Half-Life: Approximately 15 hours
• Bioavailability: Readily absorbed, not significantly affected by food
• Primary Excretion Route: Renal (as metabolites)

Benefits

• Promotes sustained wakefulness and alertness throughout the day, helping to combat pathological sleepiness.
• Improves cognitive function, including enhanced memory, focus, and executive function in states of sleep deprivation.
• Reduces the inherent sleep propensity and impairment associated with shift work sleep disorder, aiding in occupational performance and safety.
• Offers a favorable side effect profile compared to traditional stimulants like amphetamines, with a lower potential for euphoria and abuse.
• Provides a long duration of action, often allowing for once-daily dosing to cover waking hours.
• Can significantly improve quality of life for individuals whose daily functioning is severely impacted by excessive sleepiness.

Common use

Waklert (Armodafinil) is clinically approved for the management of excessive sleepiness (hypersomnia) associated with three primary conditions. In patients with narcolepsy, a chronic neurological disorder characterized by poor regulation of sleep-wake cycles, it is used to reduce the frequency of uncontrollable episodes of daytime sleep. For individuals with obstructive sleep apnea (OSA), it is prescribed as an adjunctive therapy to standard treatments like continuous positive airway pressure (CPAP). While CPAP treats the underlying apnea events, Waklert addresses the residual excessive sleepiness that may persist despite adequate airway management. Finally, it is indicated for shift work sleep disorder (SWSD) to improve wakefulness during scheduled work hours (typically night shifts) for those who experience insomnia when attempting to sleep or excessive sleepiness when required to be awake.

Dosage and direction

The recommended dosage of Waklert is 150 mg or 250 mg taken orally once daily in the morning. For patients with narcolepsy or OSA, the dose is typically taken upon waking. For patients with shift work sleep disorder, the dose should be taken approximately 1 hour before the start of their work shift. Administration can be with or without food, though a consistent routine is advised. The dosage should be individualized based on clinical response and tolerability. It is not recommended for use in the pediatric population. The entire tablet should be swallowed whole with a glass of water; it should not be crushed, split, or chewed.

Precautions

Patients should be closely monitored for the emergence of new or worsening psychiatric symptoms, including depression, anxiety,mania, psychosis, or suicidal ideation. There have been reports of serious skin reactions, including Stevens-Johnson Syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); therapy should be discontinued at the first sign of rash. Waklert is not a replacement for sleep, and patients must be counseled on maintaining good sleep hygiene practices. Use with caution in patients with a history of cardiovascular disease, including left ventricular hypertrophy, mitral valve prolapse, and recent myocardial infarction, due to potential increases in heart rate and blood pressure. Caution is also advised in patients with a history of substance abuse, although the abuse potential is considered low.

Contraindications

Waklert is contraindicated in patients with a known hypersensitivity to armodafinil, modafinil, or any of the inactive ingredients in the formulation. Its use is also contraindicated in patients with a history of serious skin reactions, such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, to any drug.

Possible side effect

The most commonly reported adverse reactions are headache, nausea, dizziness, and insomnia. Other frequently observed side effects include anxiety, dry mouth, diarrhea, and palpitations. Less common but more serious potential side effects include severe dermatological reactions (e.g., SJS, DRESS), angioedema, multi-organ hypersensitivity reactions, persistent sleepiness despite dosing, and psychiatric symptoms such as depression, mania, hallucinations, and suicidal thoughts. Patients should report any severe or persistent side effects to their healthcare provider immediately.

Drug interaction

Waklert is a moderate inducer of CYP3A4/5 and may also inhibit CYP2C19. This activity can decrease the systemic exposure and efficacy of drugs that are metabolized by these enzymes. Concurrent administration may necessitate dosage adjustments for the following:

• Cyclosporine: Reduced efficacy of the immunosuppressant.
• Steroidal Contraceptives (e.g., ethinyl estradiol): Effectiveness may be reduced; alternative or backup methods of contraception are recommended during and for one month after therapy.
• Triazolam, Midazolam: Decreased sedative effects.
• Phenytoin, Warfarin: May require monitoring and dose adjustment.
• Diazepam, Omeprazole, Propranolol: Exposure to these drugs may be increased due to CYP2C19 inhibition. Conversely, drugs that induce CYP3A4 (e.g., carbamazepine, rifampin) may decrease armodafinil levels, while drugs that inhibit CYP3A4 (e.g., ketoconazole, itraconazole) may increase them.

Missed dose

If a dose is missed, it should be taken as soon as possible on the same day. However, if it is late in the day or near bedtime, the missed dose should be skipped entirely to prevent subsequent insomnia. Do not double the next dose to make up for a missed one.

Overdose

In cases of overdose, symptoms may include insomnia, central nervous system excitation (e.g., restlessness, agitation, confusion), tachycardia, hypertension, and gastrointestinal distress (e.g., nausea, diarrhea). There is no specific antidote for armodafinil overdose. Treatment should be symptomatic and supportive, potentially including cardiovascular monitoring and the administration of activated charcoal if ingestion was recent. In severe cases, hospitalization may be required.

Storage

Store Waklert tablets at room temperature (20°C to 25°C or 68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the medication in its original blister pack or container to protect it from light and moisture. Always keep all medications out of the reach of children and pets.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a neurologist specializing in sleep disorders, I have found Waklert to be a highly effective and well-tolerated option for my patients with narcolepsy. The once-daily dosing and sustained effect significantly improve their ability to function throughout the day without the jitteriness associated with older stimulants.” – Dr. E. Vance, MD
• “After years of struggling with residual sleepiness even with perfect CPAP compliance for my sleep apnea, my doctor prescribed Waklert. The difference is night and day. I finally feel awake and alert, which has improved my work performance and overall mood. The only side effect I experienced was a mild headache for the first few days.” – Mark T.
• “Working the night shift as an ER nurse was destroying my quality of life. I was exhausted at work and couldn’t sleep during the day. Taking Waklert an hour before my shift allows me to be sharp and focused during critical moments. It’s been a game-changer for my career and my safety.” – Sarah L., RN
• “While effective for wakefulness, I did experience significant anxiety and insomnia when I first started taking the 150mg dose. My doctor reduced it to 50mg, and it’s now effective with minimal side effects. It’s crucial to work with your doctor to find the right dose for you.” – Anonymous Patient
• “The clinical data supporting armodafinil’s pharmacokinetic profile is robust. Its longer half-life compared to racemic modafinil provides a more stable plasma concentration, which translates to consistent efficacy for patients, particularly those with shift work disorder who require coverage for a full 12-hour shift.” – Clinical Pharmacologist Review