Melatonin now available over the counter

Monday, 28 June 2021

A recent change has occurred to the scheduling of the drug melatonin. Melatonin can help with sleep difficulties and is now available over the counter to people over 55 years of age. It is compounded by pharmacies in varying strengths and sold under various brand names with a strength of 2mg and modified release. Melatonin still requires a prescription from your doctor to be dispensed for people under 55 years, or for long-term use.

What is melatonin?

Melatonin is a natural chemical that is produced in the body to help regulate our sleep-wake cycle, the circadian rhythm. Darkness causes the body to start producing melatonin naturally, this signals to the brain that it is time for sleep. Light on the other hand, signals to the body to decrease melatonin production and to prepare to wake up.

Melatonin in the body naturally increases about two hours prior to going to sleep. It helps to establish body conditions suitable to begin sleeping.

Melatonin can help to alleviate difficulty with sleep in two ways:

  • When you have trouble getting to sleep, melatonin will help to make you feel sleepy.
  • To help reset your body clock when it is not aligned with time of day, such as in jet lag or when sleep is delayed such as ‘night owls’ who stay awake late into the evening.

Causes of insomnia

Insomnia is when a person has difficulty sleeping despite having adequate opportunity and have an environment conducive to sleep. Sleep complaints may include:

  • Difficulty in falling to sleep or maintaining sleep.
  • Waking up too early.
  • Feeling unrefreshed after sleeping or waking too early.
  • Or feeling fatigued and experiencing difficulty with concentrating due to sleep issues.

Lifestyle factors may trigger or worsen sleep issues, these include:

  • Evening habits not conducive to healthy sleep behaviours like going to bed with the television running or screen time in bed.
  • Drinking substances such as alcohol, coffee, cola or energy drinks.
  • Experiencing stressful events such as family, financial or anxiety causing events.
  • Shift work, jet lag or having a sedentary lifestyle.

Medication can also have an effect on sleep and cause insomnia. These medications may include:

  • Beta-blockers such as atenolol or metoprolol.
  • Diuretics such as furosemide and spironolactone.
  • Stimulants such as dexamphetamine, methylphenidate or pseudoephedrine.

If you are concerned that your medication is keeping you awake, talk to your pharmacist or doctor about alternatives.

Accessing appropriate treatment

Melatonin has now been rescheduled as a Pharmacist Only medicine and is available for short term treatment of insomnia in adults over 55 years of age.

What is available?

Melatonin in modified release tablets containing 2mg or less of melatonin in packs containing no more than 30 tablets will be available.

Melatonin that is specially compounded in pharmacies is not available over the counter.

Who is it available to and under what conditions?

The conditions must all be met to obtain melatonin over the counter from your pharmacist:

  • Melatonin must be used as monotherapy (the only medication) for insomnia.
  • The person is over 55 years of age.
  • Treatment is for insomnia of less than three weeks duration.

Adults over 55 years that require ongoing treatment with melatonin are still required to see their general practitioner (GP) for a prescription.

How to use melatonin

Your pharmacist will decide if melatonin is suitable for you by asking you a range of questions about your sleeping issues.

When taking melatonin:

  • Be aware that melatonin is used to promote sleep and can impair mental alertness, possibly even the next day. Do not drive or operate machinery if mental alertness is affected.
  • Take the medication after food, at least one to two hours before bed.
  • Swallow whole, do not crush the medication.
  • Take as a single dose at bedtime.
  • Do not use for longer than three weeks without review from your GP.
  • Do not use with other medications such as sedating antihistamines.

Adverse effects that have been reported with use of melatonin occur at a rate similar to placebo.

Healthy sleep behaviours

Medications are only of benefit to help with sleep when healthy sleep behaviours have been addressed. This includes:

  • Exercising regularly.
  • Maintaining a regular bedtime.
  • Avoiding daytime naps.
  • Reducing stimulation such as screen time from television or using your phone one hour before bed.
  • Reducing drinking fluids before bed and avoiding alcohol and caffeine before bed.
  • Sleeping in a room that is dark, quiet and with a comfortable temperature (not too cold or hot).
  • Using relaxation techniques to reduce stress such as meditation, mindfulness or deep breathing exercises before bed.

When is melatonin not available?

Melatonin will only be supplied over the counter when these conditions are met. This means a prescription will still be required to supply melatonin:

  • To children and adults under 55 years.
  • When more than one sleep medication is being used, even if you are over 55 years.
  • And used for a longer period of time.

Your pharmacist may request that you see your GP for a review to discuss your sleep issues.

Melatonin is not a long-term solution to treat sleeping issues, in this case you should see your GP or pharmacist for a review and suggestions to help implement strategies to improve your sleep.


By Alison Crow Pharmacist, CDE

Keywords: medication

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