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Narcolepsy

Narcolepsy is a chronic brain disorder that involves poor control of sleep-wake cycles. People with narcolepsy have episodes of extreme daytime sleepiness and sudden, irresistible bouts of sleep (called "sleep attacks") that can occur at any time, and may last from seconds or minutes

Prevalence

50/100,000

165,500

US Estimated

256,750

Europe Estimated

Age of Onset

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ICD-10

G47.4

Inheritance

Autosomal dominant

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Autosomal recessive

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Mitochondrial/Multigenic

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X-linked dominant

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X-linked recessive

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Rare View

Narcolepsy is a disorder that disrupts sleep-wake processes. Its primary symptom is excessive daytime sleepiness (EDS), which occurs because the brain is unable to properly regulate wakefulness and sleep. The cause of narcolepsy isn't well understood but may involve genetic factors and abnormal signaling in the brain. Narcolepsy causes sudden attacks of sleep. Sudden loss of muscle tone and hallucinations might occur.

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5 Facts you should know

FACT

1

The most typical symptoms are excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations

FACT

2

About 70% of those affected also experience episodes of sudden loss of muscle strength, known as cataplexy

FACT

3

There is increasing evidence that narcolepsy is an autoimmune disorder

FACT

4

Type 1 narcolepsy is defined as narcolepsy with cataplexy; Type 2 is narcolepsy without cataplexy

FACT

5

The loss of hypocretin-producing neurons in the hypothalamus is the primary cause of type 1 narcolepsy

Narcolepsy is also known as...

Narcolepsy is also known as...

Gelineau's syndrome; Hypnolepsy; Narcoleptic syndrome; Paroxysmal sleep

What’s your Rare IQ?

Which of the following celebrities suffers from narcolepsy?

Common signs & symptoms

Cataplexy

Excessive daytime somnolence

Excessive daytime sleepiness

Hallucinations

Sensory hallucination

Transient global amnesia

Abnormal rapid eye movement sleep

Abnormality of vision

Abnormality of sight

Slurred speech

Syncope

Fainting spell

Current treatments

The medication(s) listed below have been approved by the Food and Drug Administration (FDA) as orphan products for treatment of this condition. Learn more orphan products.

Modafinil

(Brand name: Provigil) Manufactured by Cephalon, Inc.
FDA-approved indication: Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

Oxybate

(Brand name: Xyrem®) Manufactured by Jazz Pharmaceuticals
FDA-approved indication: Treatment of cataplexy associated with narcolepsy.

Top Clinical Trials

TitleDescriptionPhasesStatusInterventionsMore Information
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic HypersomniaThis study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.Phase 2RecruitingDrug: Modafinil|Drug: Amphetamine-DextroamphetamineClick here for more information
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.Phase 1RecruitingDrug: ADAIR 10 mg IR tablets|Drug: d-amphetamine sulfate|Drug: PlaceboClick here for more information
Clarithromycin Mechanisms in Hypersomnia SyndromesThe purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in two related conditions, narcolepsy without cataplexy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging [MRI] and electroencephalogram [EEG] brainwaves), inflammation, bacteria living in the gut, and cerebrospinal fluid, to better understand how clarithromycin can reduce sleepiness. This study will recruit 92 participants who will be randomized to receive clarithromycin or a placebo for 14 days.Phase 2RecruitingDrug: Clarithromycin|Drug: PlaceboClick here for more information
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without CataplexyThis study is of an investigational drug called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.Phase 2RecruitingDrug: SUVN-G3031|Drug: PlaceboClick here for more information
A Study of TAK-994 in Adults With Type 1 and Type 2 NarcolepsyThe main aims of the study are:

To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
To check what dose range provides adequate relief of narcolepsy symptoms.
To check how much TAK-994 stays in the blood of participants, over time.
Phase 2RecruitingDrug: TAK-994|Drug: PlaceboClick here for more information
An Open Label Study of FT218 in Subjects With NarcolepsyAn Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with NarcolepsyPhase 3RecruitingDrug: FT218Click here for more information

Top Treatments in Research

AgentClass/Mechanism of ActionDevelopment StatusCompanyClinical StudiesMore Information
TAK-994Oral orexin agonist - novel, orally available OX2R-selective agonist with >700-fold selectivity against orexin 1 receptor.Phase IITakeda Pharmaceutical CompanyClick here for more informationClick here for more information
FT218Extended-release formulation of sodium oxybatePhase IIIAvadel PharmaceuticalsClick here for more informationClick here for more information
SUVN-G3031Orally-bioavailable Histamine H3 Receptor Inverse AgonistPhase IISuven Life Sciences LimitedClick here for more informationClick here for more information
AXS-12 (reboxetine)Selective norepinephrine reuptake inhibitor thought to modulate noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognitionPhase IIAxsome TherapeuticsClick here for more informationClick here for more information

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