melatonin
Orphan DrugEMA Approved, FDA OTC
Description
Melatonin is a hormone that regulates circadian rhythms and sleep-wake cycles. In Smith-Magenis syndrome, patients have inverted melatonin secretion patterns, and exogenous melatonin administration helps normalize sleep disturbances. It has orphan designation for Smith-Magenis syndrome in Europe.
Indications & Therapeutic Use
sleep disorders in Smith-Magenis syndrome, insomnia, circadian rhythm disorders
Linked Diseases:
Smith-Magenis syndrome
D058496
Global Availability (9 countries)
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Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
melatonin
| Generic Name | melatonin |
| Brands | 1 brand available |
| Active Ingredient | melatonin |
| Drug Class | sleep disorders in Smith-Magenis syndrome |
| Manufacturer | Neurim Pharmaceuticals |
| Dosage Forms | oral tablet 2mg, 5mg; prolonged-release tablet 2mg; oral liquid 1mg/mL |
| Medical Code | N05CH01 |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Lead Time | 7 days |
| Reg. Status | EMA Approved, FDA OTC |
| Clinical Trial | NCT01906866 |
| Countries | 9 countries |
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations10 Validated Nodes