Passionflower, CBD and “rest” formulations: the French framework

Passionflower (Passiflora incarnata L.) appears in the order of 24 June 2014 that lists the plants authorised in food supplements in France. Its composition combines flavonoids, harmane alkaloids in small quantities and GABA precursors. The European Pharmacopoeia recognises several forms: dry extract, tincture, dried aerial parts.

The European Medicines Agency (EMA), through its HMPC committee, has published a monograph on *Passiflora incarnata* recognising traditional use for mild symptoms of stress and for sleep. That status concerns only herbal medicines registered in pharmacies. On the food supplement side, no health claim is entered in the register of Regulation (EC) No 1924/2006: a brand may therefore not write "for sleep" or "natural anxiolytic" on its label.

For an evening supplement, melatonin is the only ingredient with a sleep claim recognised by EFSA, under Regulation (EU) No 432/2012: it "contributes to the reduction of time taken to fall asleep" from 1 mg per intake before bedtime. That is why most compliant "rest" formulations in France combine melatonin and passionflower, the latter remaining present without a claim of its own.

For a "rest" gummy combining passionflower and CBD, two locks now apply. First, the Novel Food status of CBD: since 15 May 2026, the Directorate General for Food has been withdrawing from the market ingested products without European validation under Regulation (EU) 2015/2283. Second, the provisionally safe daily dose set by EFSA on 9 February 2026: around 0.0275 mg/kg/day, that is nearly 2 mg for a 70 kg adult, a threshold well below usual commercial dosages. To understand this change in detail, our article on CBD gummies revisits the concrete consequences of the withdrawal.

The French National Institute for Sleep and Vigilance (INSV) and the Haute Autorité de Santé recommend hygiene measures as first line: regular hours, limited screens in the evening, a cool dark bedroom, physical activity during the day, stimulants avoided after 2 p.m. Where insomnia has become established, cognitive behavioural therapy (CBT-I) remains the reference treatment, ahead of any food supplement.

CBD is not a medicine. In case of persistent insomnia, consult a healthcare professional.

Is passionflower a sleeping pill?

No. No marketing authorisation recognises it as such in France. The plants order authorises it as a food ingredient, with no possibility of a therapeutic claim.

Is a passionflower-CBD gummy still sold in France?

Not as regards the ingested CBD part. Since 15 May 2026, these products have been withdrawn from the market for want of a Novel Food authorisation. Supplements with passionflower alone remain authorised, with no sleep mention.

How long before bedtime should a "rest" supplement be taken?

For melatonin formulations, intake is advised around 30 minutes before bedtime. Melatonin may cause drowsiness: avoid driving after taking it.

What alternatives are there for lasting insomnia?

The HAS recommends cognitive behavioural therapy for insomnia as first line, available from a psychologist or a trained doctor, ahead of any recourse to medication.