Night2 Sleep Spray

Curated from: Sire – Men’s Health Clinic

Night2 Sleep Spray

Product and Safety Information

Disclaimer: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.

What does Night2 Sleep Spray contain?

The active ingredient in Night2 Sleep Spray is melatonin. One spray of Night2 Sleep Spray (0.2mL of liquid) contains an equivalent of 0.3mg of melatonin. One bottle of Night2 Sleep Spray contains 12 mL of oral liquid.

Night2 Sleep Spray also contains the excipients: Stabiliser E473, Preservative E211, Sequestrant E386, Thickener E422, Pineapple Flavour, Humectant E1520, Sweetener E955, Ammonium Glycyrrhizate, Purified water

What is melatonin?

Melatonin belongs to a natural group of hormones produced by the pineal gland in the brain to control the sleep-wake cycles. The enzymes responsible for melatonin synthesis are activated and depressed by light and dark cycles. Release of melatonin follows a circadian rhythm generated by the suprachiasmatic nuclei in response to daylight alterations.

How does Night2 Sleep Spray work?

Night2 Sleep Spray is used to promote healthy and quality sleep.

When taken as a supplement, the function of melatonin is to mimic the effects of the natural hormone. Most of the actions of melatonin are mediated through the binding and activation of melatonin receptors.

Apart from regulating sleep-wake cycle it also plays a role in mood, learning and memory, immune activity, dreaming, fertility and reproduction. In addition, melatonin is also an effective antioxidant. Reduced melatonin production has also been proposed as a likely factor in the significantly higher cancer rates in night workers.

Features of Night2 Sleep Spray:

Unlike currently available formulations Night2 Sleep Spray contain nanoparticles which show rapid gastric emptying thereby increasing rate of absorption
The nanoparticles in Night2 Sleep Spray are unaffected by varying stomach and intestinal tract pH conditions
The nanoparticles in Night2 Sleep Spray is unaffected by fed-fast variation hence predictable oral bioavailability
Nano-encapsulation of melatonin in Night2 Sleep Spray improves stability of melatonin
Nano-encapsulation of melatonin makes Night2 Sleep Spray highly palatable

How should I take Night2 Sleep Spray?

Oral use. One to two sprays to be taken daily before bedtime.

Otherwise, take this medicine exactly as how your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Directions for use

Remove the plastic cap (Fig. 1)
Priming: hold the container upright. Point the black spray opening in a safe direction away from your face and other people. Fully press down on the pump with your forefinger. Release the pump and let the pump return to the starting position.
Hold the container upright with forefinger on top of the grooved button (Fig 2)
Open the mouth and bring the container as close to it as possible (Fig 3)
Press the button firmly to make sure that a full dose of Night2 Sleep Spray is sprayed directly into your mouth under your tongue.
Let the pump return to the starting position (for next dose repeat step 5&6)
Close the bottle with cap (Fig 4)
Avoid swallowing immediately after administering the spray
Following administration don’t rinse mouth for 2-5 minutes

Do NOT inhale Night2 Sleep Spray

Contraindications

Night2 Sleep Spray is contraindicated in patients with a known hypersensitivity to any ingredient of the product (see WHAT DOES NIGHT2 SLEEP SPRAY CONTAIN?)

Precautions

Keep out of the reach of children.

Night2 Sleep Spray should be used with caution in patients suffering with renal impairment, bleeding disorders, depression, hypertension and seizure disorder.

Night2 Sleep Spray may increase blood sugar levels in patients with diabetes. It can also alter immune function in individuals on immunosuppressive therapies or those who have undergone transplants.

Drowsiness

Night2 Sleep Spray may cause drowsiness. Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.

Effects on ability to drive and operate machinery

Night2 Sleep Spray has moderate influence on the ability to drive and use machines. Nevertheless, patients should avoid engaging in hazardous activities (such as driving or operating machinery) after taking Night2 Sleep Spray.

Effects on fertility

No significant effects on fertility or reproductive performance were observed in rats given oral melatonin prior to mating through to early gestation at doses over 900-fold the recommended clinical dose, based on body surface area.

Use in pregnancy

No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended.

Use in lactation

Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk. There are data in animal models including rodents, sheep, bovine and primates that indicate maternal transfer of melatonin to the foetus via the placenta or in the milk. Therefore, breast-feeding is not recommended in women under treatment with melatonin.

Renal insufficiency

The effect of any stage of renal insufficiency on melatonin pharmacokinetics has not been studied. Caution should be used when melatonin is administered to such patients.

Hepatic impairment

Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment. Therefore, Night2 Sleep Spray is not recommended for use in patients with hepatic impairment.

Carcinogenicity

An oral lifetime carcinogenicity study with melatonin in rats showed an increased incidence of thyroid follicular cell adenomas in males at doses around 700-fold the recommended clinical dose, based on body surface area. No neoplastic tissue histopathology was examined at lower doses and therefore the no-effect dose could not be determined. These effects were associated with liver enzyme induction in this species and are unlikely to be relevant to humans.

Genotoxicity

Results from a standard battery of in vitro and in vivo assays showed no evidence of a genotoxic potential for melatonin.

Interactions with other medicines

Tell your healthcare provider if you take any of the following because these drugs may interact with Night2 Sleep Spray.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Pharmacokinetic interactions

Hepatic enzymes

Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations. The clinical relevance of the finding is unknown. If induction occurs, plasma concentrations of concomitantly administered drugs can be reduced.

Melatonin does not appear to induce CYP1A enzymes in vitro at supra[1]therapeutic concentrations. Therefore, interactions between melatonin and other active substances as a consequence of melatonin’s effect on CYP1A enzymes are not likely to be significant.

Melatonin’s metabolism is mainly mediated by CYP1A enzymes. Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible: Quinolones – CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure. Carbamazepine and rifampicin – CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin.

Fluvoxamine – Caution should be exercised in patients on fluvoxamine, which increases melatonin levels (17-fold higher AUC and 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19. The combination should be avoided.

5- or 8-methoxypsoralen – Caution should be exercised in patients on 5- or 8- methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism.

Cimetidine – Caution should be exercised in patients on cimetidine, a CYP2D inhibitor which increases plasma melatonin levels by inhibiting its metabolism.

Cigarette smoking – Cigarette smoking may decrease melatonin levels due to induction of CYP1A2. Oestrogens – Caution should be exercised in patients on oestrogens (e.g. contraceptives or hormone replacement therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2.

Other – There is a large amount of data in the literature regarding the effect of adrenergic agonists/antagonists, opiate agonists/antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion. Whether or not these active substances interfere with the dynamic or kinetic effects of Night2 Sleep Spray or vice versa has not been studied.