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Kleine-Levin syndrome (KLS) is a rare neurological disorder of unknown origin characterized by relapsing-remitting episodes of hypersomnia in association with cognitive and behavioral disturbances.
Features include: Confusion, Vivid hallucination, Excessive hunger (polyphagia), and Episodic hypersomnia.
Organ System | Phenotype Count | Example Features |
|---|---|---|
Brain and nerves | 1 | Vivid hallucination |
Digestive system | 1 | Excessive hunger (polyphagia) |
No approved treatments are currently available for Kleine-Levin syndrome. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for Kleine-Levin syndrome, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for Kleine-Levin syndrome. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: 1-9 in 1,000,000 (Rare).
1 clinical trial registered, 1 recruiting. Interventions under study include other interventions. Research is primarily sponsored by academic and government institutions.
Data assembled from 6 of 12 sources · Last updated Oct 3, 2026, 11:02 PM UTC
Patient Advocacy Groups (PAGs) provide support, resources, and community for patients and caregivers.
Online Mendelian Inheritance in Man
European rare disease database
Genetic and Rare Diseases Info Center
Common questions about Kleine-Levin syndrome
Designated
Exclusivity End |
|---|
Designation Status |
|---|
Lithium carbonate | Lithium carbonate | Laboratoires Delbert SAS | 2024 | — | Designated |
1 trial found
AI-curated news mentioning Kleine-Levin syndrome
Updated Jul 7, 2026
In recognition of Rare Disease Day, NeurologyLive provided updates on various rare neurological diseases, including Kleine-Levin syndrome, amyotrophic lateral sclerosis, and Lennox-Gastaut syndrome. The event aims to raise awareness and support advocacy efforts globally, highlighting the ongoing challenges faced by patients and clinicians.
A case study highlights the resolution of Kleine-Levin syndrome following the resection of an intraventricular neurocytoma. This research contributes to understanding neurosurgical conditions associated with hypersexuality.