






Wakelix 4.45 Tablet
Product Summary :
Wakelix 4.45 Tablet is a psychostimulant that is used to treat excessive daytime sleepiness or cataplexy in people aged 6 years and older. It acts on H3 receptors to increase histamine activity in the brain and help reduce symptoms of narcolepsy. It is usually taken once daily in the morning upon waking. Some common side effects in adults may include insomnia, nausea, and anxiety. Wakelix 4.45 Tablet must not be used in people with severe liver disease.Written By Dr. Nikita Saini, MBA, MDS,
Reviewed By Dr. Dheeraj Kumar Sharma, PhD, M.Pharm,
Last updated on 12 Oct 2026 | 01:03 AM (IST)
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General Information







Product introduction
Wakelix 4.45 Tablet should be taken exactly as prescribed by the doctor. It is taken once daily in the morning upon waking. Your doctor may increase your dose gradually depending on the response and tolerability. If you ever miss a dose, take the next dose the following morning rather than taking an extra dose.
The most common side effects in adults may include insomnia, nausea, and anxiety. However, in children, the most common side effects may include headache and insomnia.
Wakelix 4.45 Tablet should not be used in people with known hypersensitivity to pitolisant and in people with severe liver diseases. Always tell your doctor about all medicines you are taking before starting treatment.
Uses of Wakelix Tablet
- Treatment of Narcolepsy (Uncontrollable daytime sleepiness)
Benefits of Wakelix Tablet
Wakelix 4.45 Tablet helps in the management of excessive daytime sleepiness or cataplexy associated with narcolepsy in patients who are 6 years and older. It can help reduce episodes of EDS, reduce the chances of disrupted sleep, and improve sleep quality.
Side effects of Wakelix Tablet
- Insomnia (difficulty in sleeping)
- Nausea
- Anxiety
- Headache
How to use Wakelix Tablet
How Wakelix Tablet works
Dosage
The dose of Wakelix 4.45 Tablet depends on the patient's age, response to treatment, tolerability, kidney and liver function, and other medicines being taken. In adults, it is generally started at a lower dose and gradually increased as advised by the doctor. Wakelix 4.45 Tablet is taken by mouth once daily in the morning upon waking.
Quick tips
- Wakelix 4.45 Tablet is usually taken once daily in the morning upon waking or exactly as advised by the doctor.
- Do not take an extra dose if you miss a dose. Take the next dose the following morning.
- Inform your doctor about all medicines you take, particularly medicines that can affect the QT interval.
- Tell your doctor if you have kidney or liver disease, as dose adjustment or additional monitoring may be required.
- Wakelix 4.45 Tablet may reduce the effectiveness of hormonal contraceptives. Use an alternative non-hormonal contraceptive method during treatment and for at least 21 days after stopping the medicine.
- Consult your doctor before using Wakelix 4.45 Tablet while you are pregnant or breastfeeding.
Safety advice

Alcohol

Pregnancy

Breast feeding

Driving

Kidney

Liver

Frequently asked questions
Fact Box
Chemical Class
Habit Forming
Therapeutic Class
Action Class
References
- Pitolisant [prescribing information]. Bethesda (MD): National Library of Medicine; 2026 [cited 2026 Sep 23]. Available from:
- National Institute of Diabetes and Digestive and Kidney Diseases. Pitolisant. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012- [updated 2021 Aug 18; cited 2026 Sep 23]. Available from:
- Guevarra JT, Hiensch R, Varga AW, Rapoport DM. Pitolisant to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy: rationale and clinical utility. Nat Sci Sleep. 2020;12:709-719. doi:10.2147/NSS.S264140. Available from:
- Pitolisant [Prescribing information]. MIMS India. [Accessed Sep 23 2026]. Available from:
- Pitolisant [Product monograph]. Drugs.com. [Accessed Sep 23 2026]. Available from:
- National Institute of Neurological Disorders and Stroke. Narcolepsy. Bethesda (MD): National Institute of Neurological Disorders and Stroke; [cited 2026 Oct 1]. Available from:




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Manufacturer details
Address: A)Formulation Division, Unit-04, Sy. No's. (Parts of) 884, 885, 929, 930, 932, 933, 935, 937-941 & 951.Mekaguda (Village), Nandigama (Mandal), Ranga Reddy (District), Pin Code - 509 228, Telangana, India.
Marketer details
Address: Formulation Division, Unit-04, Sy. No's. (Parts of) 884, 885, 929, 930, 932, 933, 935, 937-941 & 951.Mekaguda (Village), Nandigama (Mandal), Ranga Reddy (District), Pin Code - 509 228, Telangana, India.
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