Wakix
- Generic Name: pitolisant tablets
- Brand Name: Wakix
Wakix (Pitolisant Tablets) side effects drug center
Wakix Side Effects Center
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.
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)
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 Reaction | WAKIX (n=152) % | Placebo (n=114) % |
| Headache* | 18 | 15 |
| Insomnia* | 6 | 2 |
| Nausea | 6 | 3 |
| Upper respiratory tract infection* | 5 | 3 |
| Musculoskeletal pain* | 5 | 3 |
| Anxiety* | 5 | 1 |
| Heart rate increased* | 3 | 0 |
| Hallucinations* | 3 | 0 |
| Irritability | 3 | 2 |
| Abdominal pain* | 3 | 1 |
| Sleep disturbance* | 3 | 2 |
| Decreased appetite | 3 | 0 |
| Cataplexy | 2 | 1 |
| Dry mouth | 2 | 1 |
| Rash* | 2 | 1 |
| * 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)
&Copy; 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.