Wakix Side Effects

Generic name: pitolisant

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 28, 2025.

Note: This document provides detailed information about Wakix Side Effects associated with pitolisant. Some dosage forms listed on this page may not apply specifically to the brand name Wakix.

Applies to pitolisant: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy. Ask your doctor for advice about good sleep habits.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Birth control pills may not work while you are using pitolisant (the active ingredient contained in Wakix) To keep from getting pregnant, use another form of birth control during treatment and for at least 21 days after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy exposure registry for patients taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Wakix

Some side effects of pitolisant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Wakix

Along with its needed effects, pitolisant may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pitolisant:

For healthcare professionals

Applies to pitolisant: oral tablet.

General adverse events

The more commonly reported adverse reactions have included insomnia, nausea, and anxiety.^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety, irritability, depression, sleep disturbance, hallucinations, cataplexy
• Uncommon (0.1% to 1%): Agitation, affect lability, abnormal dreams, dyssomnia, middle insomnia, initial insomnia, terminal insomnia, nervousness, tension, apathy, nightmare, restlessness, panic attack, decreased libido, increased libido
• Rare (less than 0.1%): Abnormal behavior, confusional state, depressed mood, excitability, obsessive thoughts, dysphoria, hypnopompic hallucination, depressive symptom, hypnagogic hallucination, mental
• Postmarketing reports: Abnormal behavior, abnormal dreams, anhedonia, bipolar disorder, depression, depressed mood, nightmare, sleep disorder, suicide attempt, suicidal ideation^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness, tremor, vertigo
• Uncommon (0.1% to 1%): Dyskinesia, balance disorder, cataplexy, disturbance in attention, dystonia, on and off phenomenon, migraine, psychomotor hyperactivity, restless legs syndrome, somnolence, epilepsy, bradykinesia, paraesthesia, tinnitus
• Rare (less than 0.1%): Loss of consciousness, tension headache
• Postmarketing reports: Epilepsy^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, vomiting, dyspepsia, abdominal pain, dry mouth
• Uncommon (0.1% to 1%): Diarrhea, abdominal discomfort, upper abdominal pain, constipation, gastroesophageal reflux disease, gastritis, gastrointestinal pain, hyperacidity, oral paraesthesia, stomach discomfort
• Rare (less than 0.1%): Abdominal distention, dysphagia, flatulence, odynophagia, enterocolitis^[Ref]

Other

• Common (1% to 10%): Fatigue
• Uncommon (0.1% to 1%): Asthenia, chest pain, metrorrhagia, feeling abnormal, malaise, edema, peripheral edema
• Rare (less than 0.1%): Pain, spontaneous abortion, sense of oppression, abnormal general physical condition^[Ref]

Cardiovascular

• Common (1% to 10%): Increased heart rate (heart rate increased; sinus tachycardia; tachycardia)
• Uncommon (0.1% to 1%): Extrasystoles, bradycardia, hypertension, hypotension, hot flush, QTc prolongation
• Rare (less than 0.1%): ECG repolarization abnormality, ECG T-wave inversion^[Ref]

At a dose of 35.6 mg/day, QTc increases of 4.2 msec were observed. With exposures 3.8-fold higher a mean QTc increase of 16 msec was observed.^[Ref]

Dermatologic

• Common (1% to 10%): Rash (eczema, erythema migrans, rash, urticaria)
• Uncommon (0.1% to 1%): Sweating, erythema, pruritus, hyperhidrosis
• Rare (less than 0.1%): Toxic skin eruption, photosensitivity, night sweats^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Pollakiuria^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased hepatic enzymes, increased GGT^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Decreased appetite, increased appetite, fluid retention, increased weight, decreased weight
• Rare (less than 0.1%): Anorexia, hyperphagia, appetite disorder^[Ref]

Musculoskeletal

• Common (1% to 10%): Musculoskeletal pain ( arthralgia; back pain; carpal tunnel syndrome; limb discomfort; musculoskeletal pain; myalgia; neck pain; osteoarthritis; pain in extremity; sciatica)
• Uncommon (0.1% to 1%): Arthralgia, back pain, muscle rigidity, muscular weakness, musculoskeletal pain, myalgia, pain in extremity,
• Rare (less than 0.1%): Neck pain, musculoskeletal chest pain, increased creatine phosphokinase^[Ref]

Ocular

• Uncommon (0.1% to 1%): Reduced visual acuity, blepharospasm^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection (pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; upper respiratory tract inflammation; viral upper respiratory tract infection)
• Uncommon (0.1% to 1%): Yawning^[Ref]

See also:

Frequently asked questions

• How does Wakix work for narcolepsy?
• Is Wakix a controlled substance?

Further information

Wakix side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer