Melatonin (melatonin)
Hypnotics Oral Tablet; Oral Tablet,Disintegrating; Sublingual Tablet, Sublingual
Last reviewed · Source: First Databank (FDB) drug data
Overview
USES: Melatonin has been used for trouble sleeping (insomnia). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time.
Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives.
Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
Generic name: melatonin
Drug class: Hypnotics
Therapeutic class: Central Nervous System Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Melatonin
Indications
No indications are available for this drug.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Melatonin/Strong Cyp1a2 Inhibitors
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Strong CYP1A2 inhibitors may significantly increase the area-under-curve (AUC) of melatonin by inhibiting CYP1A2.(1,2) Fluvoxamine, a strong CYP1A2 inhibitor, has also been shown to increase endogenous melatonin levels.
CLINICAL EFFECTS: The concurrent administration of melatonin and strong CYP1A2 inhibitors may result in significantly increased melatonin levels and subsequent side effects.(1-3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The UK manufacturer of melatonin recommends against the concurrent use of melatonin and CYP1A2 inhibitors.(1) The Australian manufacturer of melatonin states concurrent use of melatonin and CYP1A2 inhibitors should be avoided.(2) Patients should be monitored for increased effects of melatonin when melatonin and CYP1A2 inhibitors are used concurrently.
DISCUSSION: In a study, fluvoxamine increased the area-under-curve (AUC) and concentration maximum (Cmax) of melatonin by 17-fold and 12-fold, respectively.(2) In a case report, a 51 year old female with chronic primary insomnia who received 5 mg melatonin at bedtime and 75 mg fluvoxamine in the afternoon experienced increased nocturnal sleep, from 2.5 hours (drug free) to 4.2 hours (melatonin alone) up to 5.5 hours per night (melatonin with fluvoxamine). Both melatonin and fluvoxamine alone increased melatonin levels; however administration of melatonin alone increased melatonin levels more than fluvoxamine alone. Concurrent use of melatonin and fluvoxamine increased melatonin levels 20-fold when compared to the administration of melatonin alone.(3) In a study involving five males, 5 mg of melatonin daily was given for one week, then 50 mg of fluvoxamine was added (administered three hours apart. The AUC of melatonin increased at least nine-fold (p<0.05). The Cmax increased at least six-fold in melatonin (p<0.01), versus the Cmax in patients who received melatonin alone.(4) Strong CYP1A2 inhibitors include: enasidenib, fluvoxamine, and viloxazine.(5)
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
- Autoimmune disease
- Systemic lupus erythematosus
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
More Frequent
- Dizziness
- Headache disorder
- Sedation hangover effect
Less Frequent
- Abdominal pain with cramps
- Acute cognitive impairment
- CNS depression
- Concentration difficulty
- Depression
- Hypotension
- Irritability
- Nausea
- Symptoms of anxiety
- Tremor
- Vomiting
Rare or Very Rare
- Panic disorder
Precautions
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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