A new sleeping pill that turns off peoples’ ‘awake’ switch rather than sedating them has been approved by the Australian Department of Health and will likely hit shelves early in 2017.
‘Belsomra’ was rejected by Australian officials last year after the Therapeutic Goods Administration found it to be only “modestly” effective while potentially causing dangerous next-day drowsiness, “abnormal sleep behaviours” and suicidal tendencies.
But the drug, officially approved for Australian use on November 16, has excited clinicians for its completely novel way of putting us to sleep – by blocking “orexin”, a recently-discovered neurotransmitter that keeps us awake.
Of three specialists to speak with The New Daily, two were cautiously positive about Belsomra, but all agreed medication played too big a role in treating insomnia.
“We really don’t know how effective it will be,” admitted Dr Garun Hamilton, Clinical Chair of the Australasian Sleep Association, who worked on the drug’s clinical trials.
Drowsiness, sleep paralysis, hallucinations
In 2015, the Australian Therapeutic Good Association rejected Belsomra due to efficacy and safety concerns.
The report cited “next day ability to drive, abnormal sleep behaviours, suicidality, effect on individuals with sleep apnoea and the effect of medicines such as antipsychotics, opioids and antidepressants” as potential issues.
According to Quarter Watch, published by The Institute for Safe Medication Practices, Belsomra received over 1000 complaints from American consumers in 2015 – mainly of ineffectiveness, sleep paralysis and hallucinations.
“We were also concerned about the limited clinical testing of suvorexant prior to FDA approval,” wrote Quarter Watch, noting the 10mg dose of the drug had been tested on just 62 patients.
Non-profit organisation Consumer Reports tested Belsomra in 2015, finding it was “expensive, barely helps and poses safety concerns”.
The study found participants who took the drug over a three-month period only fell asleep on average six minutes faster than those who took a placebo.
Striking the balance
“I think that at the end of the day you’ve gotta look at balancing effectiveness and side effects,” Dr Hamilton told The New Daily.
One issue repeatedly raised both in the US and by Australian officials was the lack of clinical testing on patients who are already on anti-depressants, anti-anxiety or anti-psychosis medication.
“People with insomnia usually have (multiple) conditions. You have to look at the whole package,” said Dr Hamilton, while noting the omission was typical practise in clinical testing.
David Cunnington, sleep physician and director of the Melbourne Sleep Disorder Clinic, said Belomra was “scientifically very exciting”.
He said compared with traditional sedative sleeping tablets such as benzodiazepines (found in brands tamazepam and diazepam), Belsomra users were less likely to feel drowsy the next day.
“I’m cautious [about Belsomra], but no more than I am with any other new drug,” Dr Cunnington said.
Angela Smith, director of the Melbourne Natural Medicine Clinic, said sleeping pills were a bandaid fix to a bigger problem.
“I don’t know anyone who feels good on a sleeping tablet, no matter what it is,” she told The New Daily, arguing a more holistic approach to insomnia was needed.
“I’ve dealt with chronic insomniacs who just refuse to take [sleeping pills] – they just don’t feel good,” she said.
Ms Smith said she encouraged patients to deal with the root of their insomnia – whether it be everyday stresses, anxiety or abnormal sleeping patterns.