Participant Characteristics
Twenty-four interviews were conducted with pharmacists (n=19) and intern pharmacists (n=5) practising in Australian community pharmacies between July and September 2022. The mean duration of the interview was 26.4 minutes (SD=6.5, Range=18 to 49 minutes). Participants had a mean age of 30 years (SD=9.1, Range=22 to 51) and were primarily female (66.7%, n=16). The majority were registered pharmacists (62.5%, n=15) working in franchise pharmacies (58.4%, n=14) and reported dealing with an average of 16 sleep complaints per day (SD=29.3, Range=3 to 150). Most pharmacists (70.8%, n=17) considered melatonin a hormonal agent, and half (50.0%, n=12) had not undergone targeted training before the down-scheduling. All participants reported increased melatonin inquiries, while the sale of other S3 sleep aids remained unchanged for 83.3% of participants (n=20) (Table 1).
Knowledge, Beliefs, and Attitudes
From Fig. 1, 91.7% (n=22) of pharmacists/intern pharmacists endorsed sleep health as a frequent concern in practice with two-thirds agreeing that sleep is an important concern among patients with comorbid conditions. Interestingly, all participants agreed that melatonin is safer than prescription sleep aids, but 37.5% (n=9) of pharmacists/intern pharmacists did not agree that melatonin was better than existing OTC sleep aids. With respect to the provision of melatonin, 91.7% (n=22) of participants were confident in counselling patients in the use of melatonin, but only 20.8% (n=5) were comfortable with widening melatonin use to all age groups. Interest in undertaking further continuing professional activities to learn about the effects of melatonin on sleep was endorsed by 87.5% (n=21) of participants. With respect to counselling, all participants endorsed counselling on the timing of melatonin administration. Advice against crushing the tablet was the next most frequently endorsed (79.2%, n=19), followed by sleep hygiene techniques and warnings about impaired concentration/driving (70.8%, n=17). Only 29.2% (n=29) endorsed providing patient information on melatonin (Fig. 2).
Interpretive Analysis
Analysis of qualitative data revealed 3 key emergent themes. Tables 2-4 provides a summary of the thematic synthesis and illustrative quotes for emergent themes.
Theme 1: Role of Melatonin: Beliefs and Attitudes
Sub-theme 1.1 Role of Melatonin: Regulating rather than Inducing Sleep
Participants described melatonin as a hormone that the body produces to regulate the circadian rhythm. Specifically, for the sleep-wake cycle, melatonin "tells the body it's time to go to bed" (P09, 30F). Pharmacists/intern pharmacists described the mechanism by which exogenous melatonin worked as "topping up natural levels" (P24, 51F) to regulate sleep rather than inducing sleep. Participants also attributed the onset of insomnia in older adults to age-related declines in melatonin levels. Beliefs about melatonin informed participants' perception of its role in managing insomnia. Pharmacists/ intern pharmacists perceived melatonin’s onset of effects to be gradual, describing its main function as "promot[ing] a good sleeping cycle" (P17, 30M), which would be suitable for chronic insomnia to recalibrate sleep. In contrast, melatonin played a smaller role in acute insomnia, noting that patients typically wanted quick symptom relief afforded by the fast onset of action from sedating antihistamines.
Subtheme 1.2 Comparing Sleep Aids
Melatonin was considered a separate category of sleep aids, perceived as less pharmacologically active than existing OTC and prescribed sleep aids. However, this reduced activity contributed to a more favourable safety profile for high-risk patient groups (i.e., elderly who are at increased risk of falls). Specifically, pharmacists highlighted the lower risk of residual sedation and that “you [can’t] really get tolerance with melatonin, because it's endogenous" (P06, 22M). Participants also referred to many instances of observing escalating doses and inappropriate long-term use of sedating antihistamines and/or benzodiazepines in practice. This further reinforced participants’ views that melatonin would be less susceptible to abuse. Although melatonin was often regarded as "natural” (P15, 23F), participants distinguished between proprietary melatonin and herbal sleep aids (e.g., valerian). Their responses highlighted ongoing concerns for herbal products, noting the inconclusive evidence base and variations between a large product base where "there are so many formulations" and being uncertain about "the ideal strength" (P05, 51M). Taken together, pharmacists felt less confident about recommending complementary products unless the patient directly requested it.
Theme 2: Preparing for Down-Scheduling: "Learning on the Job"
Subtheme 2.1 Pharmacists' Perception of Melatonin Down-Scheduling
In general, pharmacists/intern pharmacists responded positively to the down-scheduling of melatonin. S3 was perceived as an appropriate balance between public access and mitigating risks associated with self-treatment. While melatonin was considered relatively safe, pharmacists strongly believed their involvement was necessary to establish therapeutic appropriateness and deter patients from self-medicating without supervision from a healthcare professional. In contrast, only one participant (P10, 28M) felt that melatonin should remain a prescription-only item. This participant was concerned about the larger pack size (i.e., 30 tablets) misrepresenting the recommended short-term 3-week treatment when melatonin is supplied by a pharmacist without a prescription. [29, 30] Further, this participant also noted that a longer-than-intended duration of treatment could potentially delay other more appropriate care by a doctor.
Subtheme 2.2 Preparation for Down-scheduling
Participants recalled little preparation in response to the down-scheduling. The level of perceived preparedness varied depending on the participant's role in the pharmacy. A minority of participants who were pharmacy managers or owners (n=4) responsible for distributing training felt adequately prepared. In contrast, employee pharmacists/intern pharmacists (n=14) expressed a mismatch in expectations in training and support received from the owners of the practice or franchise head office. These participants did not feel adequately supported with clinical information about melatonin during the transition phase, often recalling that they were “ learning on the job” (P03, 23F). Information related to down-scheduling provided by owners or head office emphasized compliance with legislative requirements such as appropriate labelling, stock placement, and restricting access to customers aged 55 and over. The responsibility for clinical up-skilling fell back on the practicing pharmacist.
Participants reported accessing a range of resources to enhance their knowledge, including educational modules created by the Pharmaceutical Society Australia (PSA) and the Pharmacy Guild of Australia, articles published in professional journals, slides used during university training, reading the Consumer Medicines Information, and accessing the Australian Medicines Handbook. Although targeted training modules were designed to assist pharmacists with down-scheduling, few participants were aware of their existence. Even among participants who completed the modules, content recall was challenging. The perceived lack of time and financial support for continuing education were other barriers to training.
Subtheme 2.3 Knowledge Gaps and Training Needs
Pharmacists felt proficient in meeting legislative requirements to address their immediate practice needs. Counselling for patients focused on drug-specific advice (e.g., swallowing tablets whole), with all participants advising patients to take melatonin 1-2 hours before bedtime. However, their responses highlighted uncertainty about melatonin use across different age groups. While pharmacists recalled clinical encounters of dispensing or compounding melatonin formulations for children prior to down-scheduling, prescription of melatonin was perceived as the physicians' remit and never actively questioned beyond " doctor said it was fine" (P07, 26F). The down-scheduling has prompted pharmacists’/intern pharmacists’ interest in understanding the dose-response relationship between melatonin and sleep promotion, the circadian science underpinning the effects of melatonin, and thresholds for melatonin levels to guide dosage titration. Participants also wanted further information to distinguish the use case between immediate- and sustained-release melatonin formulations.
Theme 3: Impact of Down-Scheduling: "Business as Usual"
Subtheme 3.1 Patients Responding to Melatonin Down-scheduling
Pharmacists across practices unanimously anticipated high demand in product-specific requests for melatonin, given the widespread publicity campaigns. Patients responded to the advertising campaigns enthusiastically with direct product requests ranging from 2 to 70 each week.
However, pharmacists felt that the publicity campaigns were "misleading" (P05, 51M) and oversimplified the process for accessing S3 medicines, which contributed to the public's confusion about their eligibility to access melatonin without a prescription. In fact, a small subset of pharmacists (n=3) recalled patients being advised by their doctor to approach their pharmacist about melatonin despite being under 55 years of age. As a result, during the initial phase of the down-scheduling, nearly all requests came from adult patients outside of the eligible age group (i.e., under 55 years of age) with the expectation that melatonin would be supplied.
Subtheme 3.2 Regulating Melatonin Use and Being in the Firing Line
While the guidelines appeared straightforward, patient misconceptions about eligibility placed pharmacists/intern pharmacists in the difficult position of educating patients and denying supply. Altercations that arose when denying the supply of melatonin were a recurring theme among participants during the initial transition period of down-scheduling. One participant reported supplying PR-melatonin in younger adults to avoid patient conflict since they didn't "think there's enough side effects for it (melatonin) to be an issue" (P15, 23F).
Melatonin supply procedures also varied between participants, ranging from entering data into dispensing software for each supply, asking for proof of identity to verify age, to simply relying on patient honesty when reporting their age. The lack of consistency between pharmacies and the extent to which eligibility was applied further contributed to pharmacist-patient tensions where “it gets really ugy..” ( P07, 26F). Since the initial down-scheduling, patients appeared to have circumvented the eligibility criteria by lying about their age, requesting supplies for older family members, or going to different pharmacies. The current supply process also made tracking melatonin use difficult, with one participant suggesting that melatonin could perhaps "be S3R[3]" (P22, 43F); [31] that is, supplies are recorded as if they were a Schedule 4 prescription and entered into an electronic database that provides supply history for a patient. However, in practice, the recommended 3-week treatment duration was rarely enforced as pharmacists were unaware or reassured of therapeutic need based on patients’ history of melatonin use.
Subtheme 3.3 Managing Insomnia: New Drug, Same Approach
The addition of PR-melatonin did not appear to change pharmacists' approach to managing insomnia. Most participants reported little to no change in the sale of other OTC sleep aids or the frequency of patient honesty. For the small subset of pharmacists (n=2) observing a reduction in benzodiazepine prescribing, this was largely attributed to the introduction of SafeScript [32], a real-time prescription monitoring system, rather than an increased awareness of melatonin. Interestingly, despite the down-scheduling, pharmacists rarely recommended melatonin for managing insomnia in criteria-concordant patients unless it was for symptom-based requests (n=10). However, such requests were rare due to the widespread publicity and marketing associated with the down-scheduling, with most patients making direct requests for melatonin. Interestingly, patients already taking another OTC sleep aid (e.g., doxylamine) were resistant to change to melatonin. Factors contributing to resistance included the high costs of melatonin relative to other OTC sleep aids and patients not wanting to discontinue an effective product as "… melatonin isn't strong enough…" (P02, 24F).
[3] Schedule 3 Recordable