Home Ingredients Melotime™ (Sustained-Release Melatonin)
Sleep Health

Melotime™ (Sustained-Release Melatonin)

Evidence Level
Limited
2 Clinical Trials
5 Documented Benefits
2/5 Evidence Score

Melotime™ is a sustained-release melatonin ingredient from Nutriventia in India. Its capsule holds coated melatonin granules designed, the maker says, to release melatonin gradually across an 8 hour night. In one maker-funded, placebo-controlled trial in 59 healthy adults with poor sleep, a 2 mg capsule taken nightly for 28 days improved sleep efficiency on overnight sleep recordings, along with total sleep time and self-rated sleep quality. Part of that gap came from sleep getting worse in the placebo group. A small single-dose study of a 5 mg capsule measured a later, lower peak and a longer half-life than immediate-release melatonin, which are blood level markers, not sleep outcomes. Prolonged-release melatonin is a prescription medicine in the EU (Circadin), a different product.

Studied Dose Sleep: one 2 mg capsule (4.44 mg granules) once nightly, 30 to 60 minutes before bed, for 28 days. Blood levels: a single 5 mg capsule taken fasting in the morning. No longer trial or other dose has been published.
Active Compound Melatonin (N-acetyl-5-methoxytryptamine) in sustained-release granules made by Nutriventia. In the sleep trial each capsule held 4.44 mg of granules equal to 2 mg of melatonin; the absorption study used a 5 mg capsule. The maker calls its release system Nutriventia EDGE and describes it as patented; the trial papers do not list the release materials.

Benefits

Sleep efficiency on overnight sleep recordings

In 59 healthy adults aged 30 to 60 with poor sleep, a 2 mg capsule nightly for 28 days raised sleep efficiency, the primary outcome, by 3.5 points while it fell 6.3 points on placebo, and total sleep, a secondary outcome, rose 24 minutes versus a 39 minute drop. Much of the gap reflects worsening on placebo. One small maker-funded trial.

Supported by Trial 1

Time to fall asleep and time awake during the night

In the same 28 day trial, measured by home sleep recordings, time to fall asleep fell by about 10 minutes on the capsule and rose by about 17 minutes on placebo, and time awake after first falling asleep fell by about 15 minutes versus a 25 minute rise on placebo. These were secondary outcomes in one maker-funded trial.

Supported by Trial 1

Self-rated sleep quality and daytime alertness

On the Pittsburgh Sleep Quality Index, scores improved by 5.6 points on the capsule versus 0.7 on placebo by day 28, with a difference from day 7. In sleep diaries, fewer people on the capsule took daytime naps and more reported feeling alert during the day. These were secondary, self-reported outcomes in one maker-funded trial.

Supported by Trial 1

Well-being scores in adults with poor sleep

On the WHO-5 Well-Being Index, a short questionnaire on mood and energy, scores rose by 13.3 points on the capsule versus 0.8 on placebo at day 28, with no clear difference at day 7. This was a secondary, self-reported outcome in the same 28 day trial funded by the maker.

Supported by Trial 1

Blood melatonin levels after a single sustained-release dose

In 16 healthy fasting adults, one 5 mg capsule gave a peak about half that of 5 mg immediate-release melatonin, reached later, with a half-life of 5.1 versus 1.0 hours and about 28 percent lower total exposure. Levels 4 to 8 hours after dosing were higher but not significantly. These are blood markers, not sleep outcomes.

Supported by Trial 2

Mechanism of action

1

Sustained-release granules

The maker and its trial papers describe coated granules that release part of the melatonin early and the rest gradually over about 8 hours, tapering before waking. In a single-dose study, melatonin peaked later and lower and was cleared more slowly than from an immediate-release capsule, which fits a slower release; the release materials are not named in the papers.

2

Night-time timing signal

Melatonin is a hormone made by the pineal gland. Its levels rise in the evening and fall toward morning, and it helps keep the sleep-wake cycle in step with day and night. A sustained-release form aims to keep blood levels up for more of the night rather than giving a short early peak.

Clinical trials

1
Melotime 2 mg for Sleep in Adults with Poor Sleep: 28 Day Maker-Funded RCT
PubMed

Randomized, double-blind, placebo-controlled parallel trial at two sites in Pune, India (April to September 2025); one Melotime capsule (4.44 mg sustained-release granules equal to 2 mg melatonin, named in the methods) or an identical placebo nightly for 28 days; registered CTRI/2025/04/085087; funded by Nutriventia, which also made the capsules; Shefali Thanawala, Rajat Shah (with ownership interests) and Alphy Lopes are Nutriventia employees, and the contract research organization author received consulting fees from Nutriventia; per-protocol efficacy analysis (Thanawala et al. 2026, Clocks Sleep)

62 healthy adults aged 30 to 60 with poor sleep quality (PSQI above 5) and no diagnosed sleep disorder (30 on the capsule, 32 on placebo); 59 completed (28 and 31).

Sleep efficiency on home polysomnography, the primary outcome, changed by +3.49 points on the capsule versus -6.30 on placebo (p = 0.001; Cohen's d 0.9). Among secondary outcomes, total sleep time changed by +23.8 versus -39.3 minutes (p = 0.001), time to fall asleep by -10.3 versus +16.7 minutes (p = 0.031) and time awake after sleep onset by -14.9 versus +24.7 minutes (p = 0.001); NREM and REM time also differed. PSQI scores improved more from day 7 (day 28: -5.61 versus -0.65, p = 0.001) and WHO-5 well-being from day 14. Several sleep measures worsened in the placebo group, which the authors could not fully explain, and the baseline recording was a single night at screening. The many secondary comparisons were tested at p < 0.05 with no correction for multiple comparisons, and a registered secondary outcome (subject and physician global assessment) was not reported. Five people on the capsule (headache, dizziness) and six on placebo reported mild adverse events, none judged related.

2
Melotime 5 mg vs Immediate-Release Melatonin, Single Dose (Blood Levels Only)
PubMed

Open-label, randomized, two-period crossover, single-dose pharmacokinetic study at one clinical research unit in Coimbatore, India (August to September 2022), 7 day washout; one 5 mg Melotime sustained-release capsule (named in the introduction) versus one 5 mg immediate-release melatonin capsule, taken fasting in the morning; registered CTRI/2022/08/044837; funded by Nutriventia; Shefali Thanawala and Rajat Shah (with ownership interests) are Nutriventia employees and the study site author received consulting fees from Nutriventia (Thanawala et al. 2024, Pharmaceutics)

16 healthy adults aged 18 to 45 (8 men, 8 women); all completed both periods.

Peak plasma melatonin was lower on the sustained-release capsule (geometric mean ratio 49.43 percent, 90% CI 38.32 to 63.77) and total exposure was lower (AUC0-t ratio 71.87 percent, 90% CI 63.16 to 81.79). Peak came later (1.26 versus 0.87 hours) and the half-life was longer (5.10 versus 1.01 hours, calculated in 11 of 16 people on the test capsule). Levels from 4 to 8 hours were higher on the sustained-release capsule, but the authors report these differences were not significant (p > 0.05). One mild vomiting episode followed the immediate-release capsule. Blood level markers only; sleep was not measured.

Side effects and drug interactions

Common Potential side effects

In the 28 day trial of 2 mg nightly, five people on the capsule reported nine mild adverse events (headache and dizziness) and six on placebo reported eight (headache and dizziness); none were serious or judged related, and blood tests and vital signs did not change. Safety beyond 28 days has not been studied for this ingredient.
Drowsiness: the EU product information for the prescription prolonged-release melatonin Circadin states it may cause drowsiness and has a moderate influence on the ability to drive and use machines. Do not drive while still drowsy.
The same product information lists effects such as headache, dizziness, irritability, restlessness, abnormal dreams and nightmares among reported adverse reactions; in the 28 day trial of this ingredient only mild headache and dizziness were reported.
Pregnancy and breastfeeding: the Circadin product information does not recommend melatonin in pregnancy or while breastfeeding, and the trials of this ingredient excluded pregnant and breastfeeding women.
The Circadin product information does not recommend prolonged-release melatonin for people with autoimmune diseases or liver impairment, because of no data or slower clearance.
Accidental ingestion: yearly US poison center reports of melatonin ingestions in children and teens rose 530 percent from 2012 to 2021; store melatonin out of children's reach.
Children: the Circadin product information states that safety and efficacy in people under 18 have not been established, and this ingredient has been tested only in adults; use in children only with a clinician.

Important Drug interactions

Fluvoxamine: raises melatonin exposure about 17-fold by blocking its breakdown; the Circadin product information says the combination should be avoided.
Other medicines that slow melatonin breakdown, such as quinolone antibiotics (for example ciprofloxacin), cimetidine, the psoralens 5-methoxypsoralen and 8-methoxypsoralen (methoxsalen) and estrogens in contraceptives or hormone therapy, can raise melatonin levels.
Carbamazepine, rifampicin and cigarette smoking can lower melatonin levels.
Sedatives (benzodiazepines, zolpidem, zaleplon, zopiclone) and alcohol: melatonin may add to sedation, and with zolpidem attention, memory and coordination were more impaired; alcohol also reduces its effect on sleep, so avoid combining.
Warfarin: case reports suggest possible harm; monitor INR. People with epilepsy should ask their neurologist first.
The 28 day trial excluded people using medicines or supplements for sleep or anxiety, so combinations were not studied. Tell your doctor or pharmacist about any supplement you take.

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Frequently asked questions about Melotime™ (Sustained-Release Melatonin)

What is Melotime?

It is a sustained-release melatonin ingredient made by Nutriventia in India and used in other brands' supplements. The melatonin is in coated granules meant to release it gradually through the night. Its sleep evidence is one 28 day placebo-controlled trial of a 2 mg capsule, funded and co-authored by the maker.

How much Melotime was used in the studies, and when?

The sleep trial used one 2 mg capsule (4.44 mg of granules) each night, 30 to 60 minutes before bed, for 28 days. The absorption study used a single 5 mg capsule. Follow the product label, and ask a healthcare provider if you take other medicines.

Does sustained-release melatonin work better than regular melatonin?

That has not been tested for this ingredient. In one single-dose blood study, a 5 mg Melotime capsule gave a lower, later peak, a longer half-life and about 28 percent less total exposure than 5 mg of immediate-release melatonin; levels later in the night were higher but not significantly. No trial has compared Melotime with regular melatonin on sleep, and a Cochrane review of jet lag trials found 2 mg of slow-release melatonin relatively ineffective, suggesting a short, higher peak may work better for that use.

Is Melotime the same as prescription prolonged-release melatonin?

No. In the EU, prolonged-release melatonin 2 mg tablets (Circadin) are a prescription medicine for short-term use in adults aged 55 or over with poor sleep quality. Melotime is a different supplement ingredient with its own, smaller evidence base, and results from Circadin trials cannot be assumed to apply to it.

Will Melotime make me groggy the next morning?

The maker markets it as non-drowsy. In its 28 day trial, fewer people on the capsule took daytime naps and more reported feeling alert than on placebo, by sleep diary. Melatonin can still cause drowsiness, so do not drive or use machines until you know how it affects you.

What is Melotime used for?

Melotime is researched primarily for Sleep Health. In 59 healthy adults aged 30 to 60 with poor sleep, a 2 mg capsule nightly for 28 days raised sleep efficiency, the primary outcome, by 3.5 points while it fell 6.

Is Melotime safe, and does it have side effects?

Side effects and cautions reported for Melotime include: In the 28 day trial of 2 mg nightly, five people on the capsule reported nine mild adverse events (headache and dizziness) and six on placebo reported eight (headache and dizziness); none were serious or judged related, and blood tests and vital signs did not change. It may also interact with some medications. Melotime is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Melotime interact with any medications?

Possible interactions include: Fluvoxamine: raises melatonin exposure about 17-fold by blocking its breakdown; the Circadin product information says the combination should be avoided. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Melotime?

NutraSmarts rates the evidence for Melotime as Limited (2 out of 5). It is backed by 2 study summaries and 11 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(11 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Thanawala S, Shah R, Lopes A, Kulkarni M, Jain B, Andhalkar N. Efficacy and Safety of Sustained-Release Melatonin Capsules (2 mg) in Healthy Adults with Poor Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial. Clocks Sleep. 2026;8(2):31. doi: 10.3390/clockssleep8020031.PubMedUsed to support: Randomized, double-blind, placebo-controlled trial at two Pune sites (April to September 2025) of one capsule of 4.44 mg sustained-release melatonin granules equal to 2 mg melatonin, identified in the full text as Melotime, nightly for 28 days in 62 healthy adults aged 30 to 60 with poor sleep quality (59 completed, per-protocol analysis). Home polysomnography sleep efficiency (primary outcome) changed by +3.49 versus -6.30 points on placebo (p = 0.001); total sleep time, sleep onset latency, wake after sleep onset, NREM and REM time, PSQI, WHO-5 and sleep diary measures also favored the capsule. Sleep efficiency was the only registered primary outcome; the other sleep measures were secondary and not corrected for multiple comparisons, and a registered subject and physician global assessment was not reported. Several measures worsened on placebo. Mild headache and dizziness in both groups, none judged related. Registered CTRI/2025/04/085087; funded by Nutriventia, with three Nutriventia employees (one with ownership interests) among the authors and a contract research author paid consulting fees by Nutriventia.
  2. Thanawala S, Abiraamasundari R, Shah R. Comparative Pharmacokinetics of Sustained-Release versus Immediate-Release Melatonin Capsules in Fasting Healthy Adults: A Randomized, Open-Label, Cross-Over Study. Pharmaceutics. 2024;16(10):1248. doi: 10.3390/pharmaceutics16101248.PubMedUsed to support: Open-label, randomized crossover single-dose study in 16 healthy fasting adults comparing a 5 mg sustained-release melatonin capsule, identified in the full text as Melotime, with a 5 mg immediate-release capsule. Peak (ratio 49.43 percent) and total exposure (AUC0-t ratio 71.87 percent) were lower on the sustained-release capsule, peak time was later (1.26 versus 0.87 hours) and half-life longer (5.10 versus 1.01 hours); levels from 4 to 8 hours were higher but not significantly (p > 0.05). One vomiting episode after the immediate-release capsule. Registered CTRI/2022/08/044837; funded by Nutriventia, with two Nutriventia employees (one with ownership interests) among the authors. Blood level markers only.
  3. Nutriventia. Melotime: product page. Nutriventia (manufacturer website, nutriventia.com). 2026;Accessed November 2026..SourceUsed to support: Not PubMed indexed; maker's own statements. Describes Melotime as sustained-release melatonin on the maker's patented Nutriventia EDGE platform, designed to mimic the body's melatonin curve and give about 8 hours of release with tapering, and markets it with claims of no next-day drowsiness. Cites only the 5 mg pharmacokinetic study. The page describes the ingredient as 100 percent melatonin with no additives while its FAQ mentions food-grade excipients, and it states no per-serving dose.
  4. European Medicines Agency. Circadin (melatonin): EPAR medicine overview. European Medicines Agency (ema.europa.eu). 2026;EU marketing authorization 29 June 2007. Accessed November 2026..SourceUsed to support: Not PubMed indexed. Official EU page stating that Circadin is a 2 mg prolonged-release melatonin tablet authorized for short-term treatment of primary insomnia in people aged 55 or over, that it can only be obtained with a prescription, and that it can cause drowsiness. Supports the statement that prolonged-release melatonin is a prescription medicine in the EU. Circadin is a different product from Melotime.
  5. European Medicines Agency. Circadin: summary of product characteristics (EPAR product information). European Medicines Agency (ema.europa.eu). 2025;Product information document (PDF file dated July 2025; the text revision date field is blank). Accessed November 2026..SourceUsed to support: Not PubMed indexed. Other product (Circadin 2 mg prolonged-release tablets, not Melotime). States that melatonin may cause drowsiness and has a moderate influence on driving; that fluvoxamine raises melatonin AUC 17-fold and Cmax 12-fold and should be avoided; that quinolones, cimetidine, 5- or 8-methoxypsoralen and estrogens may raise levels and carbamazepine, rifampicin and smoking may lower them; that alcohol reduces its effect and that it may enhance the sedation of benzodiazepines and zolpidem-type hypnotics; that use in pregnancy, breastfeeding, autoimmune disease and liver impairment is not recommended; and lists adverse reactions including headache, dizziness, irritability, abnormal dreams and nightmares.
  6. Wade AG, Ford I, Crawford G, McConnachie A, Nir T, Laudon M, Zisapel N. Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Med. 2010;8:51. doi: 10.1186/1741-7015-8-51.PubMedUsed to support: Other product (prolonged-release melatonin, the product licensed in Europe, not Melotime). Randomized double-blind trial in 791 adults aged 18 to 80 with primary insomnia: over 3 weeks, sleep latency fell more than on placebo in elderly patients (-19.1 versus -1.7 minutes, p = 0.002) but not in patients selected for low melatonin output; improvements were maintained over 6 months with no signs of tolerance, and adverse events did not differ meaningfully from placebo.
  7. Luthringer R, Muzet M, Zisapel N, Staner L. The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia. Int Clin Psychopharmacol. 2009;24(5):239-49. doi: 10.1097/YIC.0b013e32832e9b08.PubMedUsed to support: Other product (prolonged-release melatonin 2 mg, not Melotime). Randomized double-blind trial in 40 patients aged 55 or older with primary insomnia: after 3 weeks, polysomnography sleep onset latency was 9 minutes shorter than on placebo (p = 0.02), sleep structure was not negatively affected, daytime psychomotor performance was not impaired, and no rebound effects were seen on withdrawal. Context for prolonged-release melatonin sleep trials using polysomnography.
  8. Lemoine P, Nir T, Laudon M, Zisapel N. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res. 2007;16(4):372-80. doi: 10.1111/j.1365-2869.2007.00613.x.PubMedUsed to support: Other product (prolonged-release melatonin 2 mg, not Melotime). Randomized placebo-controlled trial in 170 primary insomnia outpatients aged 55 or older: over 3 weeks, quality of sleep and morning alertness improved more than on placebo, with no evidence of rebound insomnia or withdrawal effects after stopping. Context for the next-morning alertness question.
  9. Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One. 2013;8(5):e63773. doi: 10.1371/journal.pone.0063773.PubMedUsed to support: Other products (melatonin in general, not Melotime). Nineteen placebo-controlled trials, 1,683 subjects with primary sleep disorders: melatonin shortened sleep latency by 7.06 minutes and increased total sleep time by 8.25 minutes, with a modest improvement in sleep quality; the authors call the effects modest but not fading with continued use. Context for the size of melatonin's sleep effects.
  10. Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database Syst Rev. 2002;(2):CD001520. doi: 10.1002/14651858.CD001520.PubMedUsed to support: Other products (melatonin in general, not Melotime). Cochrane review noting case reports suggesting that people with epilepsy and patients taking warfarin may come to harm from melatonin. It also reports that 2 mg slow-release melatonin was relatively ineffective for jet lag, suggesting a short-lived higher peak works better for that use. Supports the warfarin and epilepsy interaction note and the sustained-release FAQ.
  11. Lelak K, Vohra V, Neuman MI, Toce MS, Sethuraman U. Pediatric Melatonin Ingestions - United States, 2012-2021. MMWR Morb Mortal Wkly Rep. 2022;71(22):725-729. doi: 10.15585/mmwr.mm7122a1.PubMedUsed to support: Other products (melatonin in general, not Melotime). US National Poison Data System: 260,435 melatonin ingestions in people aged 19 or younger were reported in 2012 to 2021 and the annual number rose 530 percent, with more hospitalizations and serious outcomes, mainly from unintentional ingestions in children aged 5 or younger. Supports the accidental ingestion note.