Wakix

Last updated on RxList: 10/21/2020
Wakix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Wakix?

Wakix (pitolisant) is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

What Are Side Effects of Wakix?

Common side effects of Wakix include:

  • insomnia,
  • nausea, and
  • anxiety

Dosage for Wakix

The recommended dosage range for Wakix is 17.8 mg to 35.6 mg daily.

What Drugs, Substances, or Supplements Interact with Wakix?

Wakix may interact with certain antidepressants, seizure medications, rifampin, antihistamines, antiarrhythmics, hormonal contraceptives, midazolam, and cyclosporine. Tell your doctor all medications and supplements you use.

Wakix During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Wakix; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to Wakix during pregnancy. Wakix may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with Wakix and for at least 21 days after discontinuing treatment. It is unknown if Wakix passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Wakix (pitolisant) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Why do we sleep? See Answer
Wakix Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or pounding heartbeats;, fluttering in your chest;
  • shortness of breath; or
  • sudden dizziness (like you might pass out).

Common side effects may include:

  • nausea;
  • anxiety; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Wakix (Pitolisant Tablets)

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow
Wakix Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • QT Interval Prolongation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the clinical trials for narcolepsy, 172 patients were treated with WAKIX in placebo-controlled trials for up to 8 weeks and in open-label extension trials for up to 5 years. In trials in which WAKIX was directly compared to placebo, 6 of the 152 patients (3.9%) who received WAKIX and 4 of the 114 patients (3.5%) who received placebo discontinued because of an adverse event.

Most Common Adverse Reactions

In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at least twice the rate of placebo) with the use of WAKIX were insomnia (6%), nausea (6%), and anxiety (5%).

Table 1 presents the adverse reactions that occurred at a rate of ≥2% in patients treated with WAKIX and more frequently than in patients treated with placebo in the placebo-controlled clinical trials in narcolepsy.

Table 1: Adverse Reactions that Occurred in ≥2% of WAKIX-Treated Patients and More Frequently than in Placebo-Treated Patients in Three Placebo-controlled Narcolepsy Studies

Adverse ReactionWAKIX
(n=152)
%
Placebo
(n=114)
%
Headache*1815
Insomnia*62
Nausea63
Upper respiratory tract infection*53
Musculoskeletal pain*53
Anxiety*51
Heart rate increased*30
Hallucinations*30
Irritability32
Abdominal pain*31
Sleep disturbance*32
Decreased appetite30
Cataplexy21
Dry mouth21
Rash*21
* The following terms were combined:
Abdominal pain includes: abdominal discomfort; abdominal pain; abdominal pain upper
Anxiety includes: anxiety; nervousness; stress; stress at work
Hallucinations includes: hallucination; hallucination visual; hypnagogic hallucination
Headache includes: cluster headache; headache; migraine; premenstrual headache; tension headache
Heart rate increased includes: heart rate increased; sinus tachycardia; tachycardia
Insomnia includes: initial insomnia; insomnia; middle insomnia; poor quality sleep
Musculoskeletal pain includes: arthralgia; back pain; carpal tunnel syndrome; limb discomfort; musculoskeletal pain; myalgia; neck pain; osteoarthritis; pain in extremity; sciatica
Rash includes: eczema; erythema migrans; rash; urticaria
Sleep disturbance includes: dyssomnia; sleep disorder; sleep paralysis; sleep talking
Upper respiratory infection includes: pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; upper respiratory tract inflammation; viral upper respiratory tract infection

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of WAKIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

General disorders and administration site conditions: fatigue

Immune system disorders: hypersensitivity (anaphylaxis)

Investigations: weight increased

Nervous system disorders: epilepsy

Psychiatric disorders: abnormal behavior, abnormal dreams, anhedonia, bipolar disorder, depression, depressed mood, nightmare, sleep disorder, suicide attempt, suicidal ideation

Skin and subcutaneous tissue disorders: pruritus

Read the entire FDA prescribing information for Wakix (Pitolisant Tablets)

© Wakix Patient Information is supplied by Cerner Multum, Inc. and Wakix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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